RESmart BPAP 25A Auto Bi-Level User Manual
Contents
1. Test Pressure CMH20 Average flow at the patient connection port L min Accessories The RESmart BPAP are not sold with mask tubing or bacterial filters Accessories may be purchased separately The RESmart product line is designed to accommodate standard CPAP tubing 22mm for easy interconnectivity of masks and air tubing WARNINGS AND CAUTION 1 This device is restricted to sale by or on the order of a physician 2 Ensure that the SD card is inserted into the device before you turn on RESmart BPAP device 3 In order to avoid impairing SD card or the data saved in it please do not insert or pull out the SD card when the device is connected to a power source RESmart BPAP 25A User Manual Unpacking the System Includedwith your RESmart unit No ltem Number RESmart BPAP Power cord Carrying Case with shoulder strap User Manual Provider Instructions Flexible tubing Extra Filter M1020 oOo N DOO KF W P Humidifier Plug 9 SD Card SN Record Serial Number IMPORTANT Ifany of the above parts are missing contact yourhome care provider To order any accessories notincluded with this system contact your home care provider Home Care Provider Contact Information RESmart BPAP 25A User Manual Available Therapies The RESmart BPAP is available in the model 25A which delivers the following therapies CPAP Delivers Continuous Positive Airway Pressure CPAP m2. Off Auto On Backup RR BPAP Mode BPM CPAP Compliance RESmart BPAP 25A User Manual Glossary Apnea Hypopnead Index A bi level mode which responds to both your inhalation and exhalation The differential pressure of IPAP and EPAP are preset by your homecare provider While in Auto mode the device will automatically adjust the IPAP and EPAP when it detects an apnea event When this feature is enabled the device automatically discontinues therapy whenever the mask is removed With this feature the device automatically initiates therapy when you begin breathing on the device This feature is always enabled Backup Respiration Rate A bi level mode that responds to 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 you do not inhale IPAP and EPAP are preset by your homecare provider When the apnea is longer than 10 seconds the device will start Backup Respiration Rate with a frequency of 10 times per minute to support respiration Breaths per Minute Continuous Positive Airway Pressure Best 30 day Adherence Score A percentage of the best consecutive 30 days of usage that meets the CPAP LCD Using an adherence threshold of 4 hours or more of continuous use each night the Best 30 Day Adherence Score will show the best adherence percentage achieved for any rolling period of 30 consecutiv
3. Problem Solution s The pressure being delivered feels different Check the altitude setting to be sure it is set to your altitude Change the altitude setting if necessary If the altitude setting is correct contact your home care provider for directions on having the RESmart BPAP serviced Please have the device s serial number ready when you call The airflow from the RESmart BPAP seems warm Replace or clean the filter Make sure the RESmart BPAP is away from bedding or curtains that could block the flow of air around the RESmart BPAP Make sure the RESmart BPAP is away from heating equipment e g forced air vents radiators The noise level of the RESmart BPAP has changed to include unusual or harsh sounds during operation Contact your home care provider for directions on having the RESmart BPAP serviced Please have the device s serial number ready when you call The RESmart BPAP will not turn on Make sure that the RESmart BPAP is plugged into a working outlet Contact your home care provider for directions on having the RESmart BPAP serviced Please have the device s serial number ready when you call Pressing the ramp button does not reduce the air pressure Contact your home care provider Ramp may not have been prescribed for you The RESmart BPAP has been dropped into water or fluids have gotten into the enclosure Discontinue use Disconnect the powe
4. WARNING To avoid electrical shock unplug the RESmart BPAP before cleaning Do not immerse the RESmart BPAP in any fluids 1 Disconnect the flexible tubing from the RESmart BPAP Gently wash the flexible tubing in a solution of warm water and a mild detergent Rinse the tubing thoroughly and air dry 2 Wipe the outside of the RESmart BPAP with a cloth slightly dampened with water and a mild detergent Let the RESmart BPAP dry before plugging in the power cord 22 RESmort BPAP 25A User Manual 3 Inspect the RESmart device and all circuit parts for any damage after cleaning Replace any damaged parts 4 For details on cleaning your mask and accessories refer to the cleaning instructions packaged with the accessories Reordering Contact your home care provider to order accessories or replacement filters Service The RESmart BPAP system does not require routine servicing The RESmart unit contains electrical and or electronic equipment When necessary dispose of the RESmart and accessories in accordance with localregulations WARNING If the RESmart device malfunctions contact your home care provider immediately Never attempt to open the RESmart BPAP s enclosure Repairs and adjustments must be performed by 3B Medical Inc authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage If necessary contact your local auth
5. or operator e The instructions inthis manual are notintended to supersede established medical protocols e This device isintended for adult use only e This device is not intended for life support e BPAP devices have the potential to allow rebreathing of exhaled air e Contact your health care professional if symptoms of sleep apnea recur e Using the RESmart BPAP at an incorrect elevation setting could result in airflow pressures higherthan the prescribed setting Always verify the elevation setting when traveling or relocating To reduce this potential observe the following e Use BMC circuit accessories e Donotwear the mask and headgear for more than a few minutes while the device isnot operating e Donot block ortry to sealthe vent holes inthe exhalation port e As with most BPAP devices ATlowBPAP pressures some exhaled gas CO2 may remain inthe mask and be rebreathed e Do not use this device if the room temperature is warmer than 86 F 30 C If this device is used at room temperatures warmer than 86 F 30 C the temperature of the airflow may exceed 106 F 41 C This could cause irritation to your airway e This equipment is not suitable for use inthe presence of a flammable anesthetic mixture in combination with oxygen or air orinthe presence of nitrous oxide e lf you notice any unexplained changes in the performance of the RESmart BPAP ifitis making Unusualorharshsounds if it has been dropped or mishandled
6. 3B T RESmart BPAP 25A System User Manual 3B Solutions in Sleep Therapy www 3Bproducts com RESmart BPAP 25A User Manual Table of Contents SYO OMS ovis ross toca ANATA INDIE ATHIONS TOF USC sanss tanueiine eee 2 WINING Be CAUTIONS uineis aii EE at 3 SPESCIICCTIONS eioi rindia a aii 5 Unpacking the System sessessessessessessrssessrssessrssessessessrssessrsse 7 Available TherdpieS sssesssesssesssessresseessressressressesssessressees 8 System FEOTUNES neneiia a eE AA 9 First TIMO SeU sianenaneanae ai 10 MIANO MME FE memenrerrerrre errr aaa 10 DEVICE SCTINGS cs uteinlnndahalannlahadiaues 13 Assembling ThE CIPCUIt ee eeccescesseeteeeeeeseeeseesseeeeeees 17 Adding a HUMIGIPIOS sis cccsccsesisecssscscorssseaseteassesessepeaaecess 18 AG GING OXYGEN iscasacssscdsndessensrdsssenssdessensrdesscosndasseeandees 19 ROUNE US Eiso errutea uE 20 CONNECTING TNE Creul esssesssesesereneresdi 20 Adjusing the Circul ssssssscsessseserenesenoi 20 USING ihe RAMP BUMON wide ted inde niet 20 Turning the SYSTEM OFF assssssesssssesssssesrsssesrsssesssssesssss 20 Leth 0 lig I a ican ree eng ee ee 21 ROUTING MGINIENANCES ox iasscisciaiainnnniAinnannian 22 Cleaning the FIter cccscsssesssssssesesesssesssessseseeenes 22 Cleaning the SyStEMM c cssccsssssscsssscssessssesssssssesseeees 22 Reordering secessacseccs eacssccslecsecescasseceacataeassasseacslaaeasseateones 23 SETVICS E E E A aera E E 23 Travelin
7. Level e Level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient bur st IEC 61000 4 4 Surge IEC 61000 4 5 6 kV contact 8 kV air 2 kV for power supply lines 1kV for input outp U t lines 1kV differential mode 2 kV commo n mode 6 kV contact 8 kV air 2 kVfor power supply lines 1 kVfor input outp ut lines kV differenti al mode 2 kV commo n mode 27 Electromagnetic Environment guidance Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Main power quality should be that of a typical home or hospital Main power quality should be that of a typical home or hospital Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Urt gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dipin Ur for 5 cycles 70 Urt 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ut for 5s RESmart gt BPAP 25A User Manual lt 5 Ut gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ur gt 95 dip in Ur for5s 28 Main power quality should be that of a typical commercial or hospital environment lf the userof the RESmart requires continued operation during power main interrupti
8. aintains a constant level of pressure throughout the breathing cycle If your health care professional prescribed ramp for you you can press the Ramp button to reduce the pressure and then gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably BPAP Delivers dual Continuous Positive Airway Pressures at set levels for inhalation and exhalation which affords added comfort during treatment Shown With Humidifier Auto BPAP Automatically adjusts dual therapy pressures for inhalation and exhalationwithin prescribed pressure ranges determined byyour physician or healthcare provider RESmort BPAP 25A User Manual System Features Handle AC Inlet Display Screen le User Buttons mmunication Humidifier Controller co Bios Connector Air Outlet Filter Cap amp Filter Device Serial Medical Product Note Bottom Display Screen All system settings total operating time and therapy hours will aopear here User Buttons These buttons can be used to turn on off the system and change the system settings Humidifier Controller This controller turns the Integrated Heated Humidifier on off and allows the heat setting to be adjusted This button allows access to iCode data when the device is turned off Air Outlet Connect the flexible tubing coaxial 22 mm here Handle This handle is for lifting and carrying the device Medical Product Note For e
9. ase at airport security stations there is a note on the bottom of the RESmart BPAP stating that it is medical equipment It may help if you also take this manual with you when you travel AC Inlet Connect disconnect the AC power cord here SD Card Slot Used to insert the SD card As a memory medium the SD card can record and save all patient treatment data Communications Connector For clinical use with the Data Management Software Connect the communications cable here RS232 Cable Filter Cap amp Filters The foam filter screens out normal household dust and pollens The filter cap is designed to reduce noise from the RESmart BPAP RESmart BPAP 25A User Manual First Time Setup Patient WARNING Do not use the RESmart BPAP system until an appropriate professional adjusts the settings Note to home care provider Before beginning setup be sure that you have available the RESmart Setup Instructions Clinician s Provider s Setup instructions are not included in this manual DO NOT connect any equipment to the RESmart BPAP unless recommended in this manual or by your health care provider CAUTION If the RESmart BPAP has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature approximately 2 hours before beginning setup Place the RESmarf BPAP on a firm flat surface l Install the Filter Place the foam filter into the filter area on the back of the RESmar
10. creen LED screen where all device settings will appear as well as iCode data and last night s sleep report User Buttons These buttons can be used when entering the Patient and Clinician s menus to change the RESmart BPAP settings User Buttons are used to go to the previous next option and operate as up and down keys to change the settings Ramp Button is used to confirm the setting change Start Stop Button will allow you to exit the Setup Menu without saving Will turn on off the blower Pressure Start Stop Button Use this button to start stop the airflow DO NOT start the airflow until the circuit tubing is connected Heated Humidifier Button Use this button when the optional Integrated Heated Humidifier has been prescribed This button will control the optional heated humidifier s output This button will also provide iCode data when humidifier is off See iCode IMPORTANT The humidifier button is active only when an Integrated Heated Humidifier is connected or when the RESmart BPAP is in the Setup Menu Refer to the Integrated Heated Humidifier s instruction for additional information Ramp Button When the airflow is turned on use this button to restart the ramp cycle which lowers the airflow pressure and then gradually increases it This will allow you to fall asleep more comfortably When the airflow is turned off use this button to access the patient menu and to retrieve the previous night s sleep
11. data Note The ramp feature is not prescribed for all users Ramp Timer Ramp Starting Treatment Pressure Pressure 11 RESmort BPAP 25A User Manual Ramp Starting Pressure Ramp P The starting pressure after blower is turned on Default setting is 4 cmH20 Treatment Pressure Min APAP The Physician prescribed pressure which is the baseline for system automatic adjustment after ramp time Default setting is 4 cmH20 Ramp Timer The ramp time from starting pressure to system automatic adjustment This enables the patient to comfortably move from wakefulness to sleep and can be adjusted in 5 minute increments Default setting is 10 minutes IMPORTANT Pressing the ramp button when the airflow is turned on will lower the airflow pressure if prescribed and then will gradually increase it IV Patient Menu Set Up Starting the Device Standby After power on system status will appear on display screen as below Work Mode o6 S Mode og P1 P2 Work Mode The starting Mode Default setting is S Mode P1 EPAP when device work on Mode S Default setting is 6hPa P2 IPAP when device work on Mode S Default setting is 8hPa Using the Ramp Button Pressing the ramp button will reduce the air pressure when you are trying to fall asleep The air pressure will gradually increase until your prescription pressure is reached If your physician prescribed ramp for you pressing the button will reduce the pressure and then grad
12. e days of use within a 90 day time frame 32 EPAP IPAP iCode LPM OSA P95 RESmart BPAP 25A User Manual Expiratory Positive Airway Pressure Inspiratory Positive Airway Pressure A feature that gives access to compliance and therapy management information using encrypted codes The iCode consists of six separate codes day 7 day 30 day 60 day 90 day 180 day displayed inthe patient menu and retrieved by pressing the humidifier buttonwhen the device is not being used Liters per minute Obstructive Sleep Apnea The 95th percentile pressure P95 is the level of pressure exceeded only 5 of the time Patient Setup Menu The display mode inwhich you can change patient adjustable device settings such as the ramp starting pressure Pressure Settings Treat P Ramp P Ramp Ramp T Reslex Rise Time INCPAP mode Treat P isthe designated fixed prescription pressure setting The designated starting pressure forramp A feature that may increase patient comfort when therapy isstarted The ramp feature reduces pressure andthen gradually increases the pressure to the prescription setting so you can fall asleep more comfortably This setting is the time at which the pressure ramp begins Atherapy feature that provides pressure relief during exhalation if enabled by your home care provider The time it takes for the device to change from EPAP to IPAP You can adjust this time for yo
13. for single patient use by prescription in the home or hospital institutional environment on adult patients It is to be used on patients gt 66lbs 30kg for whom positive airway pressure therapy has been prescribed The system can deliver bilevel therapy or auto bilevel therapy Contraindications The RESmart BPAP device should not be used if you have an insufficient respiratory drive to endure brief interruptions in non invasive ventilation therapy The BPAP is not a life support ventilator and may stop operating with power failure or in the unlikely event of certain fault conditions If you have any of the following conditions tell your doctor before using the BPAP e Acute sinusitis or inner ear infection e Conditions predisposing to a risk of aspiration of gastric contents e Epitaxis causing a risk of pulmonary aspiration e Hypotension or significant intravascular volume depletion e Inability to maintain a patent airway or adequately clear secretions e Pneumothorax or pneuMomediastinum e Recent cranial trauma or surgery Caution should be used when prescribing BPAP for susceptible patients such as those with cerebral spinal fluid leaks abnormalities of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1989 96 1425 1426 Contact your health care professional if you have any questions concerning your therapy RESmoart BPAP 25A User Manual WARNING Indicates the possibility for injury to the user
14. g with RESMAN nnen a aT 24 WOWBISSMOOTIAG surasane niaii E 25 EMC REQUIFEMENTS cscccesscccsssccsssecsssecessecesseeesstecsseecees 26 COSA aa vss E TEE EA EE E 32 LITE WGITGIALY viszccscevesnes sdecesoeavsvexeadetessocessntd EE 35 iCode is a trademark of BMC Medical Co Ltd 3B and Solutions in Sleep Therapy are trademarks of 3B Products LLC RESmart is a registered trademark of BMC Medical Co Ltd RESmoart BPAP 25A User Manual Symbols Control Buttons D Pressure Start Stop A Ramp Start v Humidifier On Off iCode aI User Button User Button Device A Attention Consult Accompanying Documents Type BF Applied part o Class II Double Insulated AC Power IPX1 Drip Proof Vertical SN Serial Number of the Product wd Manufacturer RESmoart BPAP 25A User Manual Important Read and understand the entire User Manual before operating this system Ifyou have any questions concerning the use of this system contact your home care provider or health care professional CAUTION Federal law restricts this device to sale by or on the order of a physician Indications for Use The 3B and BMC RESmart BPAP system is a Bi level PAP Bi level Positive Airway Pressure device designed for the treatment of adult Obstructive Sleep Apnea OSA The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device These devices are intended
15. if the enclosure is broken orif water has entered the enclosure disconnect the power cord and discontinue use Contact your home care provider e To avoid electrical shock disconnect the power cord before cleaning DO NOTimmerse the device in any fluids e To remove AC power disconnect the power cord from the electrical outlet e The use of accessories other than those specified or recommended by the manufacturer may adversely impact performance of the device e Inspect the power cord often for any signs of damage Replace a damaged cord immediately e DO NOT use the RESmart BPAP if the display is erratic Contact your homecare provider for further instructions RESmoart BPAP 25A User Manual CAUTION Indicates the possibility of damage to the device e Makesure the RESmart BPAP iskept away from any heating or cooling equipment e g forced air vents radiators air conditioners Also make sure that bedding curtains or other items are not blocking the filter or vents of the device Air must flow freely around the device for the system towork properly e Tobacco smoke may cause tar build up within the RESmart BPAP that may result inthe device malfunctioning IMPORTANT Additional warnings and cautions are located throughout this manual as they apply WARNING DO NOT connect any equipment to the RESmart BPAP unless recommended by BMC oryour health care provider CAUTION Ifthe RESmart BPAP hasbeen exposedto e
16. ion port Whenthe RESmart BPAPisturned off there will not be enough fresh air provided through the mask and exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can insome circumstances lead to suffocation This warning applies to most PAP devices 17 RESmort BPAP 25A User Manual WARNING If you are using a full face mask i e a mask covering both your mouth and your nose the mask must be equipped with an anti asphyxia valve Accessories Contact your home care provider for additional information on the accessories available for the RESmart BPAP When using optional accessories always follow the instructions enclosed with the accessories Adding a Humidifier The Integrated Heated Humidifier is available from your home care provider The humidifier may reduce nasal dryness andirritation by adding moisture and heat if applicable to the airflow WARNING The RESmart unit should only be connected to the humidifiers or accessories specified in this Manual Connection of other Items may result in injury or damage to the RESmart unit 18 RESmart BPAP 25A User Manual Using Oxygen with Device Oxygen may be added at the mask connection Please note the warnings listed belowwhen using oxygenwith the RESmart BPAP WARNING The oxygen supply must comply with the localregulations for medicaloxygen Turn the RESmart BPAP on before turning the oxygen on Tur
17. is automatically generated and users can not change it This screen is only for reference Your home care provider may periodically ask you for this information Use Days 0 Exit the Settings The settings are complete Press the user button to access the SAVE setting and Ramp Button to save all changes and exit the settings menu Save 15 RESmart BPAP 25A User Manual Reviewing Sleep Data The RESmart allows review of the prior night s sleep data To access your data make sure that the blower is not running by pressing the stop start button Press the Ramp Start button and scroll through the display using the buttons The data displayed consists of completion time Compl P95 95th percentile of the airway pressure over time AHI apnea hypopnea index and SNI snore index View Your Sleep Report with iCode Step 1 Press the humidifier button to retrieve your iCode string Continuously pressing the humidifier button steps through all iCode values iCode 1 day 7 day 30 day 60 days etc Step 2 To generate a report go to www bmc iCode com There are three mandatory fields required to generate a report the device serial number retrieval date and iCode string All other fields are optional and may be entered depending on the requirements for the report For instructions on viewing your sleep report go to the Patient Portal at www 3bproducts com o
18. ither very hot or very cold temperatures allow it to adjust to room temperature approximately 2 hours before beginning setup WARNING DO NOT use the RESmart BPAP if the display is erratic Contact your home care provider for further instructions RESmart BPAP 25A User Manual Specifications Device Size Dimensions 8 66 x 7 6 x 4 4 220 x 194 x 112mm with Integrated Heated Humidifier Weight 3 5 Ibs 2 2 kg 4 8 Ibs 3 kg 6 6 Ibs with Integrated Heated Humidifier Product Use Transport and Storage Operation Transport and Storage Temperature 41 F to 86 F 5 to 30 C 4 F to 131 F 20 to 55 C Humidity lt 80 Non condensing lt 93 Non condensing Atmospheric Pressure 860 to 1060 cmH20 500 to 1060 cmH20O Mode of Operation Continuous Work Mode CPAP Auto BPAP BPAP SD Card Capacity 2G bytes AC Power Consumption 100 240V AC 50 60Hz 95VA max Type of Protection Against Electric Shock Class Il Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection Against Ingress of Water IPX1 Drip Proof Vertical Pressure Range 4 to 25 cmMH20 in 0 5 cmH20 increments Pressure Stability 4 to 25 CMH20 1 cmMH20 Altitude setting Manual setting level 0 2 Automatic altitude compensation for therapy pressure 5 RESmart BPAP 25A User Manual Sound Pressure Level lt 30 dB when the device is working at a pressure of 10 cmH20O Maximum Flow
19. m Ability To Use Smartphone Apps MM For use with all RESmart BPAP models As simple as taking a picture Absolutely free of charge Take a photo of the display and generate a sleep report Automatically email physician or provider GET IT ON 4 Download on the P gt Google play App Store 16 RESmort BPAP 25A User Manual VI Assembling the Circuit interface Mask Tousethesystem you willneedthe following accessories in order to assemble the recommended circuit 11 Maskwith integrated exhalation port 12 6ft 1 83 m flexible Tubing included 13 Headgear forthe mask a Connect the flexible tubing to the airoutlet onthe front of the RESmart BPAP b If you are using a mask with a built in exhalation port connect the mask s connector to the flexible tubing If you are using a mask with a separate exhalation port connect the flexible tubing to the exhalation port Position the exhalation port so that the vented air is blowing away from your face Connect the mask s connector to the exhalation port WARNING Do not block or otherwise try to seal the air openings vent holes on the exhalation port Explanation of the warning The RESmart BPAP is intended to be used with masks and circuits that have an exhalation port designed to exhaust C02 fromthe circuit When the RESmart BPAP is turned on and functioning properly new air from the RESmart BPAP flushes the exhaled airoutthrough the exhalat
20. mitter in watts W according tothe transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from RESmart BPAP 25A User Manual fixed RFtransmitter as determinedbyan electromagnetic site survey should be less than the compliance levelin each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applied NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and 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 RESmart is used exceeds the applicable RF compliance level above the RESmart should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the RESmart gt Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m 31 AHI Apnea Auto BPAP Auto
21. n the oxygen off before turning the RESmart BPAP off Explanation of Warning When the RESmart BPAP is turned off but the oxygen flow is still turned on oxygen may accumulate within the RESmart BPAP enclosure and create a fire risk Turning the oxygen off before turning the RESmart BPAP off will prevent oxygen accumulation in the RESmart BPAP and will reduce the risk of fire This warning applies to most PAP devices Oxygen accelerates fires Keep the RESmart BPAP and the oxygen container away from heat open flames any oily substance orothersources of ignition DO NOTsmoke in the area near the RESmart BPAP or the oxygen container 19 RESmart BPAP 25A User Manual Connecting the Circuit Interface Mask and Tubing 1 Connect the circuit by attaching tubing to air outlet on the device or on the integrated humidifier airoutlet IMPORTANT Before each use examine the flexible tubing for any damage or debris If necessary clean the tubing toremove the debris Replace any damaged tubing a Connect the maskto the headgear following the instructions included with the headgear b Put on the mask and headgear and breathe normally through your nose The airflow should automatically start when you begin breathing through the circuit Ifthe airflow does not start within four breaths press the pressure start stop button on the top of the RESmart BPAP When operating the system with some mask types orsome circ
22. ng is only effective when the Auto Off setting is disabled Default setting is Disable Alert Disable 14 RESmart BPAP 25A User Manual Setting Reslex This setting monitors the inhale and exhale timing in therapy the pressure will be lower when exhale so the patient will feel more comfortable The pressure setting can be changed between level 0 to 3 The default setting 0 indicates that the feature is disabled Reslex 0 Setting the Delay Off When the optional RESmart Heated Humidifier is used this setting allows the air flow continue for about 15 minutes at very low pressure about 2hPa after the RESmart BPAP is turned off This will blow off the left vapor and protect the RESmart BPAP Default setting is Enable DelayOff Enable Setting the RiseTime Rise time settings are adjustable by the patient and the provider from O off to 3 Rise time varies from 150 msec to 400msec dependent on patient setting and the pressure differential from IPAP to EPAP The rise time setting should be adjusted according to the patient comfort level Default setting is 2 Risetime 2 Setting the Date The current date is displayed and can be modified if needed Note Check and confirm this Date Setting frequently to ensure the usage log is correct Date Use Days The number of nights the RESmart BPAP was used for therapy for more than 4 hours will appear The number
23. ons it is recommended that the RESmart be powered from an uninterruptible power supply or from battery RESmart gt BPAP 25A User Manual If the pressure deviates more than is indicated in the device specification itmay Power be necessary to frequency position the RESmart 50 60Hz further from sources of magnetic field 3A m 0 3 A m Power frequency magnetic fields The power frequency magnetic field should be measured inthe intended installation location to ensure that it is sufficiently low NOTE Uristhe AC main voltage prior to application of the test level IEC 61000 4 8 29 RESmart gt BPAP 25A User Manual Guidance and manufacturer s declaration electromagnetic immunity The RESmart is intended for use in the electromagnetic environment specified below The user of the RESmart should make sure that it is used in such an environment Immunit y Test Conducted 61000 4 6 Radiated RF IEC 61000 4 3 Complianc e Level Electromagneti c Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the RESmart including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 2VP d 1 2 VP 80 MHz to 800 MHZ d 2 3VP 800 MHz to 2 5 GHz where P isthe maximum output power rating of the trans
24. orized dealer or 3B Medical nc for technical support and documents If you notice any unexplained changes in the performance of the RESmart BPAP if it is making unusual or harsh sounds if it has been dropped or mishandled if the enclosure is broken or if water has entered the enclosure discontinue use Contact yourhome care provider 23 RESmart BPAP 25A User Manual Traveling with RESmart When you are traveling the carrying case is for carry on luggage only The carrying case will not protect the system if it is stored as checked baggage Security Stations For convenience at security stations there is a note on the bottom of the RESmart device stating that it is medical equipment It may be helpful to bring this manual along with you to help security personnel understand the RESmart BPAP Checking the Power Cord If you are traveling to a country with a line voltage different than the one you are currently using a different power cord or an international plug adapter may be required to make your power cord compatible with the power outlets of the country to which you are traveling Contact your home care provider for additional information 24 RESmart BPAP 25A User Manual Troubleshooting The table below lists common problems you may have with the RESmart BPAP and possible solutions to those problems If none of the corrective actions solve the problem contact your homecare provider
25. r cord from the AC wall outlet Contact your home care provider for directions on having the RESmart BPAP serviced Please have the device s serial number ready when you call 25 RESmart gt BPAP 25A User Manual EMC Requirements Guidance and manufacturer s declaration electromagnetic emissions The RESmart is intended for useinthe electromagnetic environment specified below The RESmart user should ensure that itis usedin such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The RESmart uses RF energy only for its CISPR 1 Class B internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Group 1 The RESmart is suitable for use in CISPR 11 Class B all establishments including domestic establishments and Harmoni Class A those directly connected to C the public low voltage power emissions supply network that supplies IEC 61000 3 2 buildings used for domestic purposes Voltage Class D fluctuation 5 flicker emissions IEC 61000 3 3 26 RESmart gt BPAP 25A User Manual Guidance and manufacturer s declaration electromagnetic immunity The RESmart isintended for use inthe electromagnetic environment specified below The RESmart user should makesure thatitis used in such an environment Immunity Test IEC 60601 Complianc Test
26. r this warranty contact your local authorized dealer or 3B Medical Inc 21301 US Highway 27 N Lake Wales FL 33859 T 863 226 6285 F 863 226 6284 For additional information please visit our Patient Portal at www 3bproducts com icodeconnect com Web based cloud for report generation and storage www bmc icode com Website for iCode data report retrieval C 0123 V 1 1113 35
27. rt Heated Humidifier is used this setting can change the temperature and humidity of airflow between level 0 to 5 Default setting is 3 Heater 3 Setting the Altitude The altitude setting can be changed between level 0 to 2 Default setting is 0 0 less than 2 460 ft lt 750 m 1 2 460 to 4 921 ft 750 m to 1500 m 2 4 924 to 8 202 ft 1501 m to 2500 m over 8 202 ft The airflow pressure may not be accurate Contact your home care provider to have your pressure setting adjusted Altitude 0 Setting Auto ON When the RESmart BPAP is standby and wearing mask your deep breath will start airflow automatically Default setting is Enable Auto On Enable Setting Auto Off When the mask is removed the RESmart BPAP will stop airflow automatically Default setting is Disabled Auto Off Disable Setting the LCD Light This setting allows you to adjust the LCD light among Auto On and Off Default setting is Auto Auto LCD light will be turned on when any button pressing and turned off after few seconds On LCD light will be turned ON always Off LCD light will be turned OFF always Light Auto Setting the Alert This setting allows you to turn on off the patient disconnect alert When a large continuous air leak such as mask removal has been detected in the circuit this setting enables disables the audible alert a beeping sound This setti
28. t wih the blue side facing out CAUTION The foam filter must be in place at all times when the RESmart BPAP is operating IMPORTANT Remove powertlothe device by disconnecting the power cord from the electrical outlet WARNING Inspect the power cord often for any signs of damage Replace a damaged cord immediately Il Attach the Integrated Heated Humidifier Please see the RESmart Integrated Heated Humidifier User Manual enclosed with your device lll Connect Power Cord Plug the socket end of the power cord into the AC inlet on the back of the RESmart BPAP Plug the pronged end of the power cord into an electrical outlet System status will appear on the RESmart BPAP screen The RESmart BPAP is powered on for use when the power cord is connected Pressing the Start Stop Button TON turns the blower on off CAUTION Make sure the RESmart BPAP is away from any heating or cooling equipment e g forced air vents radiators air conditioners Also make sure that bedding curtains or other items are not blocking the filter or vents of the device Air must flow freely around the device for the system to work properly Standby 10 RESmart BPAP 25A User Manual When you plug the device into a power source it will be in Standby mode The blower will not engage unless you put your mask on or you press the start stop button After powering on the system status will appear on display screen as described below Display S
29. ts of the RESmart BPAP Air must flow freely around the RESmart device for the system to work properly e f the airflow from the RESmart BPAP feels cold reposition the circuit tubing so that it runs under your bed covers to reduce heat loss while you sleep e If interruption of the power supply occurs during system function the audible alert a beeping sound will start and continue Restoration of the power supply will stop the audible alert e After interruption and restoration of the power supply the RESmart BPAP will automatically resume the working status before interruption 21 RESmart BPAP 25A User Manual Routine Maintenance Replacing the Filter It is recommended that the air filter be changed every 30 days 1 Remove the filter cap by gently pressing on its bottom 2 Remove the foam filter by gently pulling around the edges of the filter Remove and replace with blue side facing out 3 Replace filter cap so that the small opening on the cap is facing down Insert the cap s tabs into the filter area opening CAUTION Operating the RESmart BPAP with a dirty filter may keep the system from working properly and may cause damage to the device Never install a wet filter in the device We recommend that you clean the filter in the morning and alternate using the filter provided with the system to ensure enough drying time for the cleaned filter Cleaning the System Clean the mask and tubing daily
30. ually increase ramp the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably Note The ramp feature is not prescribed for all users Press the Ramp button on the top of the RESmart BPAP You can use the Ramp button as often as you wish during the night Turning the System OFF Remove the mask and headgear Press the pressure start stop button on the top of the RESmart BPAP to stop the airflow Or if the Auto Off setting has been enable the airflow will automatically turn off 12 RESmart BPAP 25A User Manual IMPORTANT The humidifier button is active only when a RESmart Heated Humidifier is connected or when the RESmart BPAP is in the Setup Menu Refer to the RESmart Heated Humidifier s instructions for additional information Helpful Hints e If the alert tone sounds press any button on the RESmart BPAP to silence the alert tone Refer to the Troubleshooting Section of the manual for further instructions e Make sure that bedding curtains or other items are not blocking the filter or vents of the RESmart BPAP Air must flow freely around the RESmart BPAP for the system to work properly e If the airflow from the RESmart BPAP feels cold reposition the circuit tubing so that it runs under your bed covers to reduce heat loss while you sleep e If interruption of the power supply occurs during system working the audible alert a beeping sound will start and contin
31. ue Restoration of the power supply will stop the audible alert e After interruption and restoration of the power supply the RESmart BPAP will resume with the working status before interruption automatically Selecting Patient Device Settings RESmart BPAP Display Screen User Button User Button Heated Ramp Button Humidifier Button Pressure Start Stop Button Depress the Ramp button for 3 seconds The airflow must be turned OFF Your are now in the Patient Menu Set up You will need to go through each option by pushing the or Button The cursor will blink and values may be changed using the User Buttons Confirm the setting by pressing the ramp again and the cursor will stop blinking Setting changes are not finalized until they are saved by pressing the ramp button on the Save screen at the end of the menu option cycle Press user buttons to access the menu settings Proceed through the following settings 1 Heater 2 Altitude 3 Auto On 4 Auto Off 5 Light 6 Alert 7 Reslex 8 Delay Off 9 Date 10 Use Days 11 Save WARNING DO NOT use the RESmart BPAP if the display is erratic Contact your home care provider for further instructions 13 RESmart BPAP 25A User Manual IMPORTANT If at any time you wish to exit the setup menu press the Pressure Start Stop Button and the display will go back to the system standby screen Setting the Humidifier When the optional RESma
32. uit configurations the airflow may NOT automatically start Adjusting the Circuit 2 Adjust the circuit Lie down on your bed and adjust the flexible tubing so itis free to move if you turn inyour sleep Adjust the mask and headgear until you have a comfortable fit andthere are no airflow leaks intoyour eyes Using the Ramp Bution Pressing the ramp buttonwill reduce the air pressure when you are trying to fall asleep The air pressure will gradually increase until your prescription pressure isreached If your physician prescribed ramp for you pressing the button will reduce the pressure and then gradually increase ramp the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably Note The ramp feature is not prescribed for all users 3 Press the Ramp button onthe top of the RESmart BPAP You can use the Ramp button as often as you wish during the night Turning the System OFF 4 Remove the mask and headgear Press the pressure start stop button onthe top of the RESmart BPAP tostop the airflow Or if the Auto Off setting has been enable the airflow will 20 RESmart BPAP 25A User Manual automatically turn off Helpful Hints e If the alert tone sounds press any button on the RESmart BPAP to silence the alert tone Refer to the Troubleshooting section of the manual for further instructions e Make sure that bedding curtains or other items are not blocking the filter or ven
33. ur comfort 33 SNI Standby Units Use Days Use Time RESmart BPAP 25A User Manual Snore Index The state of the device when power is applied but flow is turned off cmH20 or hPa Total days where use exceeds 4 hours Total hours this device been used 34 RESmart BPAP 25A User Manual Limited Warranty 3B Medical Inc warrants that the RESmart BPAP will be free of all defects in workmanship and materials and will perform according to specifications for a period of two 2 years of sale from the sale of the device and 90 days on any accessories If the product fails to perform in accordance with the product specifications 3B Medical Inc will repair or replace at its option the defective material or part This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship 3B will issue an RMA Return Merchandise Authorization within 24 hours of receipt of written notification of a failed or defective unit Failed defective units must be returned within 30 days of the RMA date This warranty coverage is applicable to all 3B BMC CPAP Auto CPAP and Auto Bi Level devices The warranty policy does not cover any damages caused as a result of alteration intentional damage modification or unauthorized repair of the device 3B reserves the right to amend this policy at any time To exercise the rights unde
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