Respironics BIPAP Pro
Contents
1. Home Care Provider BiPAP Pro Setup Instructions Bi level System Bina E www respironics com Always use these instructions along with With Bi Flex the User Manual when assembling or The BiPAP Pro Bi level system is intended for the adjusting this equipment treatment of adult obstructive sleep apnea only System Contents Electrical Requirements BiPAP Pro User With Manual AC Power Consumption 100 to 240 VAC 50 60 Hz 1 0 A max DC Power Consumption 12 VDC 4 0 A max Type of protection against electric shock Class II Equipment Degree of protection against electric shock Type BF Applied Part Degree of protection against ingress of water Ordinary Equip ment IPX0 Pressure Range 3 to 20 cm H O in 1 cm H O increments Mode of Operation Continuous Pollen Filters Optional Ultra fine Filter lexible Tubing ft 1 83 m x 22 mm I D Included with the BiPAP Pro is the Encore Data Management software SmartCard feature that records device usage Another feature is the FOSQ Quality of Life questionnaire Your patients can periodically complete this questionnaire and send either you or their health care professional their answers recorded on the SmartCard The FOSQ questionnaire is detailed in the enclosed Sleep Apnea Solutions brochure Symbols O Pressure ON OFF 0123 A Ramp a Table of Contents Type BF Applied Part Warnings amp Cautions cccceeeeeeee 2 D2. Class Il Double Insulated ContraindicationS c ccsesseeseees 2 IPXO Ordinary Equipment PACCOSSOMOS citietcceicsccvcrscescttoxnaranwnmnsescs 3 System Setup uN Attention consult STE La LOt g aaa 4 accompanying documents Therapy Display Screens 6 CE European CE Marking pee Adjustment Screens be Warnings amp Cautions CAUTION WARNING Indicates the possibility for injury to the user or the operator CAUTION Indicates the possibility of damage to the device Contraindications US federal law restricts this device to sale by or on the order of a physician This device is intended for adult use only This device is not intended for life support CPAP and bi level devices have the potential to allow rebreathing of exhaled air To reduce this potential observe the following Use Respironics circuit accessories Do not wear the mask and headgear for more than a few minutes while the device is not operating Do not block or try to seal the vent holes in the exhalation port As with most CPAP and bi level devices At low CPAP pressures some exhaled gas CO may remain in the mask and be rebreathed Do not use this device if the room temperature is warmer than 95 F 35 C If this device is used at room temperatures warmer than 95 F 35 C the temperature of the airflow may exceed 106 F 41 C This could cause irritation to your airway This equipment is not suitab
3. Yes To Mode change the mode press the button below No until the correct mode appears Press the button below Yes to confirm the setting Mode Bi level Yes No Choose the c If you chose the Bi level mode the Comfort Control Comfort Control feature will appear It allows you to set the transition Parameter time from EPAP to IPAP Because Comfort Control is not a prescribed setting this parameter is adjustable so that the patient can find the most comfortable setting Comfort Control parameters appear in the diagram to the right A setting of Off will result in normal BiPAP transition from EPAP to IPAP Settings of 1 2 and 3 will progressively increase the amount of time between EPAP and IPAP You may change this param eter at any time If the setting is correct press the button below Yes To change the setting press the button below 1 until the correct setting appears Press the button below Yes to confirm the setting NOTE The user can also adjust the Comfort Control param eter See the BiPAP Pro User Manual for more informa tion Comfort 1 Yes System Setup Therapy Menu Display Screens Or Choose the d If you chose the Bi Flex mode the Bi Flex level will Bi Flex appear The Bi Flex feature adjusts bi level therapy Level by inserting a small amount of pressure relief during IPAP the latter stages of inspiration and during active exhalation
4. automatically transferred into the device and erased from the SmartCard The SmartCard will then start to collect patient data Downloading Data Programming a SmartCard Changing Settings Using a SmartCard WARNING System Setup SmartCard You can download data from the SmartCard by one of two methods 1 Connect the BiPAP Pro with the SmartCard installed directly to a Windows compatible computer using the Encore software Communications Cable available from Respironics Connect one end to the Communications connector on the back of the BiPAP Pro Connect the remaining end to the computer s communication port 2 Open the patient s file in the Encore software or create a new patient file Choose Extract Data from the Communications menu You can view the extracted data using the Encore software Or 1 Connect a Respironics SmartCard reader writer directly to a Windows compatible computer following the instructions included with the reader writer Remove the SmartCard from the BiPAP Pro and insert it into the reader writer 2 Open the patient s file in the Encore software or create a new patient file Choose Extract Data from the Communications menu You can view the extracted data using the Encore software To program the SmartCard with a patient s prescription 1 Connect a Respironics SmartCard reader writer directly to a Windows compatible computer following the instructions in
5. or contact Respironics Repairs and adjustments must be performed only by trained personnel fully acquainted with this equipment Service performed by unqualified personnel or installation of unauthorized parts could cause personal injury invalidate the warranty or result in costly damage If you need technical assistance call Respironics Technical Service Department 1 800 345 6443 US Customer Service or 1 724 387 4000 International Customer Service J RESPIRONICS INC RESPIRONICS C 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewerbestrasse 17 0123 15668 8550 USA 82211 Herrsching Germany 12 1007221 LG 5 25 01
6. the beginning part of exhalation In the EPAP diagram to the right the bold lines represent Bi Flex in comparison to the dashed line representing normal BiPAP therapy Bi Flex levels of 1 2 or 3 progres sively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of Pme expiration If the setting is correct press the button below Yes To change the setting press the button below 1 until the correct setting appears Press the button below Yes to confirm the setting NOTE If the Bi Flex setting chosen does not correspond to the patient s breathing rate adjust the setting for a more natural breathing rate NOTE The user can also adjust the Bi Flex level setting See the BiPAP Pro user manual for more information Set the IPAP e The IPAP and EPAP pressure settings will be displayed and EPAP If the pressure setting is correct press the button below Yes IPAP Pres 12 Yes 1 Pressures To change the pressure press the button below 1 until the correct pressure is displayed Press the button below Yes to confirm the setting IPAP Range 3 to 20 cm H O 1 cm H O increments EPAP Range 3 to IPAP setting 1 cm H O increments EPAP Pres 10 Yes 1 NOTE If CPAP therapy is desired set the IPAP and EPAP to the same pressure setting NOTE The IPAP setting cannot be set lower than the EPAP setting Once the IPAP setting has reac
7. 5 Range 5 to 45 minutes 5 minute increments Set the h The minimum ramp pressure will be displayed The patient also has Minimum access to this setting in the Patient Setup Menu Min Ramp P 5 Ramp If the minimum ramp pressure is correct press the button es bis Pressure below Yes To change the minimum ramp pressure press the button below 1 until the correct pressure is displayed Press the button below Yes to confirm the setting Range 3 cm H O to EPAP pressure setting 1 cm H O increments i The mask alert setting will be displayed When turned On the Mask Alert mask alert will sound whenever a large continuous leak such as Mask Alert 0n Setting mask removal has been detected in the circuit and the correct Yes No pressure cannot be delivered to the patient The patient also has access to this setting in the Patient Setup Menu If the setting is correct press the button below Yes To change the setting press the button below No Press the button below Yes to confirm the setting Auto On Setting Auto Off Setting Therapy Hours Setting Save and Exit Settings IMPORTANT l The therapy hours will be displayed This screen displays the m You have completed all of the settings System Setup Therapy Menu Display Screens j The Auto On setting will be displayed The Auto On feature allows the airflow to automatically turn on when the patient N begins brea
8. 989 96 1425 1426 The use of positive airway pressure therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection This therapy is not for use with patients whose upper airways are by passed Should your patient have any of these conditions a physician will determine if Bi level therapy is appropriate WARNING DC Power CAUTION Using an Ultra fine Filter Supplemental Oxygen WARNING WARNING WARNING WARNING WARNING Accessories Do not connect any equipment to the BiPAP Pro unless recommended by Respironics or the health care professional Verify that an exhalation port is present to exhaust CO from the circuit If circuit accesso ries other than those recommended by Respironics are connected to the BiPAP Pro then pressures must be verified Use of these accessories may alter the pressure received reducing the effectiveness of treatment Recommended Patient Circuit e Respironics Nasal Mask with integrated exhalation port or Respironics mask with separate exhalation port such as the Whisper Swivel IT e Respironics 6 ft 1 83 m reusable flexible tubing e Respironics Headgear for the mask not shown The Respironics DC Power Cord can be used to operate the BiPAP Pro noe system in a stationary recreational vehicle boat or motor home g The Respironics DC Battery Adapter Cable enables the BiPAP Pro system to be operated from a 12 VDC free standing b
9. IPAP Pressure After several seconds the bottom line of the display screen will flash Ramp EPAP You can now press the ramp button to change the display to the EPAP setting ae Press the button below 1 or 1 to raise or lower the EPAP pressure After several seconds the bottom line of the display IPAP Pres 12 screen will flash Ramp Exit You can now press the Ramp 1 1 button to exit the Pressure Adjustment Menu IPAP Range 3 to 20 cm H O 1 cm H O increments EPAP Range 3 to IPAP setting 1 cm H O increments 10 System Setup Pressure Adjustment Menu Display Screens Service CAUTION Total Operation Time NOTE If CPAP therapy is desired set the IPAP and EPAP to the same pressure setting NOTE The IPAP setting cannot be set lower than the EPAP setting Once the IPAP setting has reached 20 pressing the 1 button will return both the IPAP and EPAP setting to 3 cm H O NOTE The delivered pressure will increase or decrease as the setting is increased or decreased The BiPAP Pro system does not require routine servicing If you notice any unexplained changes in the performance of this device if it makes unusual or harsh sounds if it has been dropped or mishandled if the enclosure is broken or if water has entered the unit discontinue use and contact your homecare provider To display the total operation time press the button below Usage The usage hours will b
10. a detailed look at patient Z usage This data may be useful in tracking patient compliance Resetting the therapy hours will not erase the total operation time or other patient data To continue adding therapy hours to the current total press the button below Keep To erase the therapy hours press the button below Erase The total therapy hours will now read 0 0 Press the button below Yes to confirm the setting To exit the Therapy Setup Menu press the button below Yes Save and Exit Yes No To make further changes to the settings press the button below No You will return to the beginning of the Therapy Setup Menu If a power interruption occurs before you exit the Therapy Setup Menu the changes will not be saved To make further setting changes after you have exited the Therapy Setup Menu you must unplug the power cord from the BiPAP Pro for a few seconds and repeat the instructions System Setup Therapy Menu Display Screens 2 Prepare the BiPAP Pro for delivery a Verify the settings Optional Pressure Verification via Manometer A water column manometer can be connected at the end of the 6 ft patient tubing for additional pressure verification When the blower is turned on the current pressure will be displayed in the upper right corner of the screen b Follow the instructions in the BiPAP Pro User Manual to install the filter s and connect the patient circuit c Fill out the in
11. attery only DC Power is not intended to be used as battery backup DO NOT connect the DC Power System while the BiPAP Pro is operating on AC power System damage may occur You can use the optional ultra fine filter in addition to the pollen filter for more complete filtration of very fine particles The ultra fine filter will be most beneficial to those who are sensitive to tobacco smoke or other substances with small particles Please note the warnings that appear next when the patient is using oxygen with the BiPAP Pro system Oxygen should be administered only on the order of a health care professional The oxygen supply must comply with local regulations for oxygen use When using oxygen with this system a Respironics Pressure Valve part number 302418 must be placed in line with the patient circuit When using oxygen with the BiPAP Pro system turn the BiPAP Pro on before turning the oxygen on Turn the oxygen off before turning the BiPAP Pro off This will prevent oxygen accumulation in the BiPAP Pro Oxygen accelerates fires Keep the BiPAP Pro 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 BiPAP Pro or the oxygen Accessories SmartCard WARNING WARNING Using the SmartCard If administering fixed flow supplemental oxygen the inspired oxygen will vary depending on the IPAP and EPAP settings the patient breathing rate and the l
12. cluded with the reader writer Remove the SmartCard from the BiPAP Pro and insert it into the reader writer 2 Open the patient s file in the Encore software or create a new patient file Choose SmartCard Wizard from the Communications menu Following the prompts complete the patient s prescription The patient s name and prescription will be saved to the SmartCard 3 Remove the SmartCard from the reader writer If desired write the patient s name on the front of the card To change the settings in the BiPAP Pro using a programmed SmartCard 1 Make sure the BiPAP Pro unit is plugged in Insert the programmed SmartCard into the slot on the left side of the BiPAP Pro logo side facing up When the Blower Off screen displays there will also be pTower off sage an arrow in the upper right corner indicating that the card is inserted correctly 2 Turn the airflow on to verify the new prescription setting The card can now be removed or you can leave the card in the BiPAP Pro to record Blower On gt device usage Once the prescription settings have been transferred to Usage Pere N the BiPAP Pro they will be deleted from the SmartCard This section provides detailed instructions for the Therapy Menu Display Screens and the Pressure Adjustment Menu Display Screens DO NOT use the BiPAP Pro if the display is erratic Contact Respironics Prescribed therapy settings can only be set using the Thera
13. e displayed for 10 seconds and Blower Off gt then return to the main screen Usage Menu L N Total Operation Time Display N M 100 T 12345 6 Exit B 12345 6 N M The amount of memory space available The SmartCard records patient usage information e g a history of pressure settings times the system was used for therapy Some health care professionals and home care providers record this information to assist in the patient s CPAP treatment When 000 is displayed the memory is full and the current data will start to overwrite the oldest data Remind your patient to check this number periodically if you wish to download the stored data before it is overwritten The data can be downloaded using the Respironics Encore software version 3 0 or higher NOTE The SmartCard must be installed for the patient usage to be recorded If the SmartCard is not installed the screen will display M 11 Service T The therapy hours are the total number of hours the BiPAP Pro has operated at therapeutic pressure including ramp time Like a trip meter in a car the therapy hours can be reset to give a detailed look at patient usage B The total blower time is the number of hours the BiPAP Pro has been in use This total includes factory testing time Exit Returns the display to the main screen If the BiPAP Pro begins to function incorrectly refer to the Troubleshooting section of the User Manual
14. eak rate Substantial leaks around the mask may also reduce the inspired oxygen concentration The oxygen flow into the patient circuit must not exceed 15 L min and the oxygen pressure must not exceed 50 psi When using the Respironics Pressure Valve place the valve in line with the patient circuit and connect the oxygen as shown here To Controlled Oxygen Source Pressure Os Enrichment Valve Attachment The BiPAP Pro is delivered with applicable Respironics software and SmartCard installed The SmartCard is a plastic card similar in size and shape to a normal credit card However instead of holding information on a magnetic stripe it holds it in a small silicon chip embedded in the card When installed into a BiPAP Pro device the SmartCard records the date time ramp usage and duration of each use minimum storage capacity 9 months When capacity is reached the oldest data is overwritten Using the Encore software version 3 0 or higher the usage data can be downloaded and viewed If the card is not installed the device usage will not be recorded When SmartCard a SmartCard is installed an arrow will be displayed in the upper right corner of the screen The SmartCard can also be programmed with the patient s prescription by using applicable Respironics software and the SmartCard reader writer available from Respironics When the programmed SmartCard is inserted into the BiPAP Pro the prescription settings are
15. formation form in the back of the BiPAP Pro User Manual and review the manual with the patient FOSQ The BiPAP Pro is programmed to allow the users to take a Functional Outcomes of Sleep Questionnaire FOSQ FOSQ is a quality of life test designed specifically for people with sleep disorders The results allow health care professionals to see how therapy has improved the quality of their patient s life By having the patients complete the questionnaire periodically they can provide valuable information about the effectiveness of their treatment Using the BiPAP Pro device to answer the questions the SmartCard will record the answers The card can then be removed from the device and mailed to the doctor for evaluation using the Encore software Refer to the Sleep Apnea Solutions brochure included with this package for further information NOTE The user has access to the FOSQ test See the BiPAP Pro User Manual for more information Pressure Adjustment Menu Display Screens Adjust the The Pressure Adjust Menu enables the medical IPAP and provider to adjust the IPAP and EPAP Pressure EPAP settings while the airflow is turned on The ramp Pressures button is disabled while you are in this menu After the airflow is turned on enter the Pressure Adjustment Menu by holding the two top user buttons down until the IPAP pressure screen is dis played Press the button below 1 or 1 to raise or lower the
16. hed 20 cm H O pressing the 1 button will return both the IPAP and EPAP setting to 3 cm H O Choose the f Choose the ramp style Bi level Linear or None Ramp Style If the ramp style is correct press the button below Yes To change the ramp style press the button below No until the correct style is displayed Press the button below Yes to confirm the setting Ramp Bi level Yes No NOTE If the ramp style is set to None the following ramp settings will not appear Go to step i System Setup Therapy Menu Display Screens Airflow Turned On Airflow Turned On Ramp Button Ramp Button IPAP Pressed IPAP Pressed Pressure Pressure ra EPAP Pressure EPAP lL Pressure Minimum Minimum Ramp Ramp Pressure Pressure 0 cm H20 0 cm H20 Ramp Time Ramp Time Minutes Minutes Bi level Ramp Linear Ramp Recommended for patients with higher EPAP Recommended for patients with lower settings Maintains the pressure differential EPAP settings or when there is a large between the IPAP and EPAP settings differential between the IPAP and EPAP settings Set the g Ramp Time will appear Ramp Time If the Ramp Time is correct press the button below Yes To change the Ramp Time press the button below 5 until the correct time is displayed Press the button below Yes Ramp Time 15 to confirm the setting Yes
17. le for use in the presence of a flammable anesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide To avoid electrical shock disconnect the power cord before cleaning DO NOT immerse the BiPAP Pro in any fluids If you notice any unexplained changes in the performance of this device if it makes unusual or harsh sounds if it has been dropped or mishandled if the enclosure is broken or if water has entered the unit discontinue use and contact your home care provider Tobacco smoke may cause tar build up that may result in the BiPAP Pro malfunctioning The BiPAP Pro must be positioned on its base for proper operation When assessing the relative risks and benefits of using this equipment the clinician should understand that this device can deliver pressures of up to 20 cm H O Also in the unlikely event of certain fault conditions a maximum pressure of 30 cm H O is possible Studies have shown that the following pre existing conditions may contraindicate the use of positive airway pressure therapy for some patients e Bullous Lung Disease e Pathologically Low Blood Pressure e Pneumothorax e Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure Caution should be used when prescribing CPAP for susceptible patients such as those with cerebral spinal fluid CSF leaks abnormalities of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1
18. py Menu and the Pressure Adjustment Menu To prevent patients from tampering with the settings the directions to access these menus should not be revealed to the patient System Setup Therapy Menu Display Screens The green signal light will come on when the unit is ready for use The light goes out when the airflow is turned on A flashing light signals a system error Eige Check the Routine Use Screen Messages section of the user manual for further instructions Display Screen Respironics 2001 v x y Setup Tip During System Setup press the left user button to confirm a correct setting press the right user button to change an incorrect Ram setting Holding the right user button down will cause the values to change more quickly Pressure On Off Button Therapy Menu Display Screens 1 Enter the Therapy Setup Menu by holding the two top user buttons down while plugging in the power cord Hold the buttons down until the unit beeps You cannot turn the airflow on when you are in this Menu When you exit this menu the Patient Setup Menu will be displayed Choose the a Choose the display language Display If the language setting is correct press the button below Language Yes To change the language press the button below No until the correct language is displayed Press the button below Yes to confirm the setting Choose the b If the mode is correct press the button below
19. thing through the connected circuit Some mask types and circuit configurations may prevent the BiPAP Pro from 7 reS No a automatically turning on The Pressure On Off button can always be used to turn the airflow on If the setting is correct press the button below Yes To change the setting press the button below No Press the button below Yes to confirm the setting k Auto Off will appear The Auto Off feature allows the airflow N to automatically turn off when the BiPAP Pro does not detect Auto Off Off breathing through the connected circuit This is usually because Yes No the mask has been removed or the tubing has become discon nected Some mask types and circuit configurations may prevent the BiPAP Pro from automatically turning off The Pressure On Off button can always be used to turn the airflow off If the setting is correct press the button below Yes To change the setting press the button below No Press the button below Yes to confirm the setting NOTE During setup if you are using a water column manometer to verify the pressure setting make sure this setting is in the Off position Otherwise the airflow will automatically turn off unless it detects breathing through the circuit total number of hours the patient has used the BiPAP Pro at Thp Hrs 12345 6 pressure including ramp time Like a trip meter in a car the Keep Erase therapy hours can be reset to give
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