User Manual
Contents
1. Make sure that the RESmart BPAP 25 25A is plugged into a working outlet Contact your home care provider for directions on having the RESmart BPAP 25 25A 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 25 25A has been dropped into water or fluids have gotten into the enclosure Discontinue use Disconnect the power cord from the AC wall outlet Contact your home care provider for directions on having the RESmart BPAP 25 25A serviced Please have the device s serial number ready when you call P18 RESmart 2 BPAP 25 25A User Manual V2 1 6 Accessories 6 1 Adding a Humidifier The InH2 Heated Humidifier is available from your home care provider The humidifier may reduce nasal dryness and irritation 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 6 2 Adding Oxygen Oxygen may be added at the mask connection Please note the warnings listed below when using oxygen with the RESmart BPAP 25 25A WARNING The oxygen supply must comply with the local regulations for medical oxygen WARNING Turn the RESmart BPAP2. Pressure Stability Static Pressure Stability 4 to 25 hPa 0 5 hPa Dynamic Pressure Stability 4 to 25 hPa 1 0 hPa Altitude Compensation Manually setting level 0 1 2 Automatic altitude compensation Sound Pressure Level lt 30 dB when the device is working at the pressure of 10 hPa RESmart e BPAP 25 25A User Manual V2 1 Specifications cont Maximum Flow Test Pressure hPa 4 10 15 20 25 Average flow at the patient connection port L min 56 62 64 66 63 P24 RESmart e BPAP 25 25A User Manual V2 1 Appendix A EMC Requirements Guidance and manufacturer s declaration electromagnetic emissions The RESmart is intended for use in the electromagnetic environment specified below The user of the RESmart should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The RESmart 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 RF emissions Group 1 CISPR 11 Class B RF emissions Group 1 CISPR 11 Class B Harmonic emissions The RESmart is suitable for use in all establishments IEC 61000 3 2 Class A including domestic establishments and those directly connected to the public low voltage power supply network Voltage fluctuations that supplies buildings used for domestic purposes flicker emi
3. 25 25A on before turning the oxygen on Turn the oxygen off before turning the RESmart BPAP 25 254 off Explanation of Warning When the RESmart BPAP 25 25A is turned off but the oxygen flow is still turned on oxygen may accumulate within the RESmart BPAP 25 25A enclosure and create a fire risk Turning the oxygen off before turning the RESmart BPAP 25 25 off will prevent oxygen accumulation in the RESmart BPAP 25 25A and will reduce the risk of fire This warning applies to most BPAP devices WARNING Oxygen accelerates fires Keep the RESmart BPAP 25 25A 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 RESmart BPAP 25 25A or the oxygen container Contact your home care provider for additional information on the accessories available for the RESmart BPAP 25 25A When using optional accessories always follow the instructions enclosed with the accessories P19 RESmart e BPAP 25 25A User Manual V2 1 7 Cleaning and Maintenance 7 1 Cleaning the Filter The foam filter should be cleaned at least once every two weeks under normal usage and replaced with a new one every six months CAUTION CAUTION Operating the RESmart BPAP 25 25A with a dirty filter may keep the system from working properly and may cause damage to the device 1 Remove the filter cap by gently pressing on its bottom 2 Change the filter a R
4. DD nn gp pa xp gyxyxogg giMMIMbMEZD DK HNH ma 20 TI v ri r DA11 HN N A E N E N N E tice a a E MN N aa 21 7 4 Traveling with RESmart A E T AE EAE S 21 ECUTUY SIAUONS irern E E E E E EE E acted E EEE ES EE 21 7 6 Checking the Power COT nani ye yiya ye seye ya nio k a Vana Va n AA k CADE ROERE E BENE W GEEN 22 SC CLIC VD NN E E E a rrr nn 23 endix A EMC Requirements i siyana naa AVANA A VE e MAW HEW AV VAN V n v EA Sass 25 RESmart InH2 are registered trademarks of BMC Medical Co Ltd BMC Medical Co Ltd 2011 P1 RESmart e BPAP 25 25A User Manual V2 1 1 Introduction 1 1 System Contents After unpacking the system make sure you have everything shown here No Item Num 1 RESmart BPAP 25 25A 1 2 Power Cord 1 3 Carrying Case 1 4 User Manual 1 IMPORTANT If any of the above parts are missing contact your home care provider Note If your system includes a humidifier you will receive additional items with your package See the instructions included with your humidifier for more information 1 2 Intended Use The RESmart BPAP System is a BiPAP Bi level Positive Airway Pressure device which is intended to provide non invasive ventilation for patients with obstructive sleep apnea OSA either in the hospital or at home The RESmart BPAP 25 25A is to be used only on the instruction of a licensed health care professional Your home care pro
5. LTD 5 F North No 2 Building No 9 Shixing Street Shijingshan District Beijing 100041 P R China Tel 86 10 51663880 Fax 86 10 51663880 Ext 810 EU AUTHORISED REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany Tel 0049 40 2513175 Fax 0049 40 255726
6. recur e Using the RESmart BPAP 25 25A at an incorrect elevation setting could result in airflow pressures higher than the prescribed setting Always verify the elevation setting when traveling or relocating P4 RESmart 2 BPAP 25 25A User Manual V2 1 Warnings Cautions and Contraindications cont 1 3 2 Cautions Caution indicates the possibility of damage to the device CAUTION e Tobacco smoke may cause tar build up within the RESmart BPAP 25 254 that may result in the RESmart BPAP 25 25A malfunctioning The use of accessories other than those specified with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components may result in increased emissions or decreased immunity of the equipment or system e This device is restricted to sale by or on the order of a physician Additional warnings and cautions are located throughout this manual as they apply 1 3 3 Contraindications The BPAP 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 otitis media conditions predisposing to a risk of aspiration of gastric contents e epistaxis causing a
7. risk of pulmonary aspiration hypotension or significant intravascular volume depletion e Inability to maintain a patent airway or adequately clear secretions e pneumothorax or pneumomediastinum recent cranial trauma or surgery P5 RESmart e BPAP 25 25A User Manual V2 1 1 4 System Overview ao amp nyo Handle r2 Display Medical Screen Product Note User Buttons bottom lllilliill Humidifier AC Inlet Controller Communications FO Connector ALO Bet Filter Cap Humidifier amp Filter Power AC Inlet Connect disconnect the AC power cord here Air Outlet Connect the flexible tubing coaxial 22 mm here Communications Connector For clinical use with the Data Management Software Connect the communications cable here Display Screen All system settings total operating time and therapy hours will appear here Filter Cap amp Filters The foam filter screens out normal household dust and pollens The filter cap is designed to reduce the noise from the RESmart BPAP 25 25A Humidifier Controller This controller turns the InH2 heated humidifier on off and allows the heat setting to be adjusted The humidifier is an optional accessory that may be purchased separately Humidifier Power This socket provides the power to the InH2 heated humidifier Medical Product Note For ease a
8. 25A settings To start the setup menu press and hold the ramp button until the setup menu appear about 5 seconds when system standby The airflow must be turned OFF IMPORTANT WARNING IMPORTANT Setting the Humidifier Pressing the ramp button when the airflow is turned on will lower the airflow pressure if prescribed and then will gradually increase it DO NOT use the RESmart BPAP 25 25A if the display is erratic Contact your home care provider for further instructions 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 a When the optional InH2 Heated Humidifier is used this setting can change the temperature and humidity of airflow between level 0 to 5 Default setting is 3 P14 RESmart e BPAP 25 25A User Manual V2 1 Device operation cont IMPORTANT Press the Ramp Button to enter change status and press User Buttons to change the setting Press Ramp Button again to confirm the setting Press User Buttons to access the next setting Heater 3 Setting the Altitude b 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 adjust
9. BPAP 25 25A is turned on and functioning properly new air from the RESmart BPAP 25 25A flushes the exhaled air out through the P11 RESmart 2 BPAP 25 25A User Manual V2 1 First Time Setup cont exhalation port When the RESmart BPAP 25 25A is turned off enough fresh air will not be provided through the mask and exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This warning applies to most BPAP devices 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 a safety entrainment valve IMPORTANT Before each use examine the flexible tubing for any damage or debris If necessary clean the tubing to remove the debris Replace any damaged tubing c Connect the mask to the headgear following the instructions included with the headgear d Put on the mask and headgear and breathe normally through your nose The airflow should automatically start when you begin breathing through the circuit lf the airflow does not start within four breaths press the pressure start stop button on the top of the RESmart BPAP 25 25A When operating the system with some mask types or some circuit configurations the airflow may NOT automatically start 3 2 2 Adjusting the breathing circuit Lie down on your bed and adjust the flexible tubing so it is free to move if you turn in yo
10. RESmart 25 25A BPAP System User Manual CE o123 RESmart e BPAP 25 25A User Manual V2 1 Table of Contents 8 App TOUT OMUCHON oes ioc cee eect Gast eS 2 11 System Contents seis ccsccccccsccccsecvncvncueevsciecatcseds cis a ENA aided cvs e EE EEE EEEE E R EERE S ESE 2 1 2 Intended Use oreroraa aea a a n n ww mec oeaeanmnabmb mmmrmm 2 1 3 Warnings Cautions and Contraindications LLL ussa ae lekar kek Eek arka ke Kek K ek 4 13 1 lr zz gggg z aa 4 VA T12 X oe c e rrrmmmm gxx 5 2 3 5 CONUPAINGICALIONS avyan yl nln ln irita EAER AEREA EEEE des esivestevtaveaveevies Lob AWA DAN VL KA 5 T4 System OVCFVICW DD eee gt gt e eeoeoeoA gt pE EDPEFHEaereraae are 6 LS GOS r oases rps crepes estes ae 7 bU MESA A OUI Cy anos a aac eee tees a A a e DD S 8 1 6 1 Control Buttons JJ E E E AE OE ME nnn dg ECEE E AEAEE E EE AE EE 8 6 2 Devilee a E sites ha eases E Ree NR 8 Device Controls and Displ ys LLE Esas Eka ae keka Eek Eek keka kk kake kek K ek Kek kre ke kak KK KK eK Ker KK Ke KA KAKA 9 First Time SO z gt eeeeD DDDDDpr r rDrrr ecvgk er r g egda 10 3 1 Installing th BUT a cc ey na naba eS Rav TE Big E EEEE 10 3 2 Connecting the Breathing Circuit LLULL EEE asa Eke E EEE ak axak kaka kx kek k kk Keke k rk Keke A 11 3 2 1 Assembling the breathing circuil LLLL E
11. at you have available the RESmart BPAP 25 25A Home Care Provider Setup Instructions Setup instructions are not provided in this manual DO NOT connect any equipment to the RESmart BPAP 25 25A unless recommended by BMC or your health care provider If the RESmart BPAP 25 25A has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature approximately 2 hours before beginning setup 3 1 Installing the Filter The foam filter must be in place at all times when the RESmart BPAP 25 25 is operating a Place the foam filter into the filter area on the back of the RESmart BPAP 25 25A b Attach the filter cap Position the cap so that the small opening on the cap is facing down Insert the cap s tabs into the filter area opening To remove AC power disconnect the power cord from the electrical outlet Inspect the power cord often for any signs of damage Replace a damaged cord immediately The RESmart BPAP 25 25A is powered on for use when the power cord is connected The pressure start stop button turns the blower on off P10 RESmart 2 BPAP 25 25A User Manual V2 1 First Time Setup cont CAUTION Make sure the RESmart BPAP 25 25A 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
12. available on certain model Default setting is Disable Alert Disable g When the optional InH2 Heated Humidifier is used this setting allows the air flow continue for about 15 minutes at very low pressure about 2hPa after RESmart BPAP 25 25A is turned off This will blow off the left vapor and protect the RESmart BPAP 25 25A Default setting is Enable DelayOff Enable h The Sensitive Setting is only effective when Auto Feature opened The sensitivity of automatically pressure adjusting can be set from 1 soft to 5 hard Default setting is 3 i Rise time settings are adjustable by the patient and the provider from 0 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 0 disable P16 RESmart e BPAP 25 25A User Manual V2 1 Device operation cont Setting the Date Use Days Exit the Settings Risetime J j 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 k The number of nights the RESmart BPAP 25 25A was used for therapy for more than 4 hours will appear This screen is only for reference Your home care provider may periodically ask you for this information Use Days J The setting
13. device for the system to work properly 3 2 Connecting the Breathing Circuit 3 2 1 Assembling the breathing circuit Place the RESmart BPAP 25 25A on a firm flat surface To use the system you will need the following accessories in order to assemble the recommended circuit Nasal Mask with integrated exhalation port 6 ft 1 83 m flexible Tubing Headgear for the mask WARNING If multiple persons are going to use the RESmart BPAP 25 25A e g rental devices a low resistance main flow bacteria filter should be installed in line between the RESmart BPAP 25 25A and the circuit tubing Pressures must be verified by your home care provider when alternate or optional accessories are in place a Connect the flexible tubing to the air outlet on the front of the RESmart BPAP 25 25A 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 25 25A is intended to be used with masks and circuits that have an exhalation port designed to exhaust CO2 from the circuit When the RESmart
14. dually increases ramps the pressure to the prescription setting so you can fall asleep more comfortably The time it takes for the device to change from EPAP to IPAP You can adjust this time for your comfort Respiratory Rate Number of breaths per minute 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 you do not inhale I PAP Inspiratory Positive Airway Pressure and EPAP Expiratory Positive Airway Pressure are preset by home care provider RESmart e BPAP 25 25A User Manual V2 1 1 6 Symbol Key 1 6 1 Control Buttons A ss oie Pressure Start Stop Ramp Start Humidifier On Off User Button User Button 1 6 2 Device AN Attention Consult Type BF Applied part m Class II Double Insulated Accompanying Documents AC Power IPX1 Drip Proof Vertical SN Serial Number of the product ud Manufacturer Authorised Reprisentative in the European Community C European CE Declaration of Conformity RESmart e BPAP 25 25A User Manual V2 1 2 Device Controls and Displays Display Screen All device settings will appear here 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 InH2 Heated Humidifier has been presc
15. e pressure start stop button on the top of the RESmart BPAP 25 25A to stop the airflow Or if the Auto Off setting has been enable the airflow will automatically turn off P13 IMPORTANT Helpful Hints RESmart 2 BPAP 25 25A User Manual V2 1 Device operation cont The humidifier button is active only when an InH2 Heated Humidifier is connected or when the RESmart BPAP 25 25A is in the Setup Menu Refer to the InH2 Heated Humidifier s instructions for additional information If the alert tone sounds press any button on the RESmart BPAP 25 25A to silence the alert tone Refer to the Troubleshooting Section of the manual for further instructions Make sure that bedding curtains or other items are not blocking the filter or vents of the RESmart BPAP 25 25A Air must flow freely around the RESmart BPAP 25 25A for the system to work properly If the airflow from the RESmart BPAP 25 25A feels cold reposition the circuit tubing so that it runs under your bed covers to reduce heat loss while you sleep If interruption of the power supply occurs during system working 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 25 25A will resume with the working status before interruption automatically 4 4 Change Device Settings Verify Change the RESmart BPAP 25
16. ed Altitude 0 IMPORTANT RESmart is already with automatic altitude compensation Even if without setting the altitude RESmart still can deliver proper pressure in any altitude worldwide Setting Auto ON c When the RESmart BPAP 25 25A is standby and wearing mask your deep breath will start airflow automatically This function is NOT available on certain model Default setting is Enable Auto On Enable Setting Auto Off d When the mask is removed the RESmart BPAP 25 25A will stop airflow automatically This function is NOT available on certain model Default setting is Enable Auto Off Enable P15 RESmart e BPAP 25 25A User Manual V2 1 Device operation cont Setting the LCD Light e This setting allows you to adjust the LCD light among Auto On and Off Default Setting the Alert Setting the Delay Off Setting the Sensitive Setting the RiseTime 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 f 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 setting is only effective when the Auto Off setting is disabled This function is NOT
17. emove the foam filter by gently pulling around the edges of the filter Rinse the filter in a steady stream of running water Squeeze out the water and repeat Air dries the filter on a rack for 8 to 12 hours or in a clothes dryer for 15 to 20 minutes b Insert the filter into the filter area on the back of the RESmart BPAP 25 25A Replace the filter cap Never install a wet filter into the RESmart BPAP 25 25A 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 7 2 Cleaning the System Clean the mask and tubing daily WARNING To avoid electrical shock unplug the RESmart BPAP 25 25A before cleaning Do not immerse the RESmart BPAP 25 25A in any fluids 1 Disconnect the flexible tubing from the RESmart BPAP 25 25A 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 25 25A with a cloth slightly dampened with water and a mild detergent Let the RESmart BPAP 25 25A dry before plugging in the power cord 3 Inspect the RESmart BPAP 25 25A and all circuit parts for any damage after P20 RESmart 2 BPAP 25 25A User Manual V2 1 Cleaning and Maintenance cont cleaning Replace any damaged parts 4 For details on cleaning your mask and accessories refer to the cleaning instructions packaged wi
18. established medical protocols e This device is intended for adult use only e This device is not intended for life support BPAP devices have the potential to allow rebreathing of exhaled air To reduce this potential observe the following Use BMC 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 BPAP devices At low BPAP pressures some exhaled gas CO2 may remain in the mask and be rebreathed 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 in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide e If you notice any unexplained changes in the performance of the RESmart BPAP 25 25A 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 disconnect the power cord and discontinue use Contact your home care provider e To avoid electrical shock disconnect the power cord before cleaning DO NOT immerse the device in any fluids Contact your health care professional if symptoms of sleep apnea
19. g this manual along with you to help security personnel understand the RESmart BPAP 25 25A RESmart e BPAP 25 25A User Manual V2 1 Cleaning and Maintenance cont 7 6 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 P22 RESmart e BPAP 25 25A User Manual V2 1 8 Specifications Device Size Dimensions 220 x 194 x 112 mm 313 x 194 x 112 mm with InH2 heated humidifier Weight 2 2kg 3 kg with InH2 heated humidifier Product Use Transport and Storage Operation Transport and Storage Temperature 5 to 30 C 20 to 55 C Humidity lt 80 Non condensing lt 93 Non condensing Atmospheric Pressure 860 to 1060 hPa 500 to 1060 hPa Mode of Operation Continuous Work Mode BPAP 25 CPAP S Mode BPAP 25A CPAP S Mode Auto S AC Power Consumption 100 240V AC 50 60Hz max 95VA 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 IPX1 Drip Proof Vertical Pressure Range IPAP 4 hPa to 25 hPa in 0 5 hPa increments EPAP 4 hPa to 25 hPa in 0 5 hPa increments
20. ive humidity should be at least 30 Mains power quality should be that of a typical home or hospital Mains power quality should be that of a typical home or hospital Mains power quality should be that of a typical commercial or hospital environment If the user of the RESmart requires continued operation during power mains interruptions it is recommended that the RESmart be powered from an uninterruptible power supply or from a battery If the pressure deviates more than is indicated in the device specification it may be necessary to position the RESmart further from sources of power frequency magnetic fields The power frequency magnetic field should be measured in the intended installation location to ensure that it is sufficiently low NOTE Uris the AC mains voltage prior to application of the test level P26 RESmart e BPAP 25 25A User Manual V2 1 Appendix A EMC Requirements cont Guidance and manufacturer s declaration electromagnetic immunit 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 immunity oi Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the RESmart e including cables than the recommended separation distance calculated from the equation applicable to the fre
21. performance is observed additional measures may be necessary such as re orienting or relocating the RESmart b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m RESmart 2 BPAP 25 25A User Manual V2 1 Limited Warranty BMC Medical Co Ltd warrants that the RESmart BPAP device shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one 1 year for main unit and three 3 months for all accessories from the date of sale by BMC MEDICAL CO LTD to the dealer If the product fails to perform in accordance with the product specifications BMC MEDICAL CO LTD will repair or replace at its option the defective material or part BMC MEDICAL CO LTD will pay customary freight charges from BMC MEDICAL CO LTD 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 BMC MEDICAL CO LTD 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 To exercise your rights under this warranty contact your local authorized dealers or MANUFACTURER BMC MEDICAL CO
22. quency of the transmitter Recommended separation distance d 1 2VP d 1 2VP 80 MHz to 800 MHz pu EN 3 Vrms d 2 3 P 800 MHz to 2 5 GHz IEC 150 kHz to 80 l l l 61000 4 6 MHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the 3 V m recommended separation distance in meters Rragiated RF go MHz to 2 5 m 61000 4 3 GHz Field strengths from fixed RF transmitter as determined by an electromagnetic site survey 3 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol i 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 people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the RESmart is used exceeds the applicable RF compliance level above the RESmart should be observed to verify normal operation If abnormal
23. ribed This button will control the optional heated humidifier s output Follow the instructions of the humidifier Ramp Button When the device works under CPAP mode and 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 Note The ramp feature is not prescribed for all users User Buttons These buttons can be used when entering various menus to change some of the RESmart BPAP 25 25A settings RESmart BPAP j 0 Display Screen User Buttons Heated Humidifier Button User Buttons Ramp Button Pressure Start Stop Button IMPORTANT In the Setup Menu the user buttons are used to go to the previous next question or setting and operate as up and down keys to change the settings the ramp button is used to confirm the setting change and the start stop button will allow you to exit the Setup Menu without saving WARNING WARNING CAUTION CAUTION IMPORTANT WARNING WARNING RESmart 2 BPAP 25 25A User Manual V2 1 3 First Time Setup Do not use the RESmart BPAP 25 25A until an appropriate professional adjusts the settings To order any accessories not included with this system contact your home care provider Note to home care provider Before beginning setup be sure th
24. s are complete Press the user button to access the SAVE setting and Ramp Button to save all changes and exit the settings menu Save P17 RESmart e BPAP 25 25A User Manual V2 1 5 Troubleshooting The table below lists common problems you may have with the RESmart BPAP 25 25A and possible solutions to those problems If none of the corrective actions solve the problem contact your home care provider 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 25 25A serviced Please have the device s serial number ready when you call The airflow from the RESmart BPAP 25 25A seems warm Replace or clean the filter Make sure the RESmart BPAP 25 25A is away from bedding or curtains that could block the flow of air around the RESmart BPAP 25 25A Make sure the RESmart BPAP 25 25A is away from heating equipment e g forced air vents radiators The noise level of the RESmart BPAP 25 25A has changed to include unusual or harsh sounds during operation Contact your home care provider for directions on having the RESmart BPAP 25 25A serviced Please have the device s serial number ready when you call The RESmart BPAP 25 25A will not turn on
25. sle kek ake ka eke keka kk keka K k AK Ax 11 3 2 2 Adjusting the breathing circuilt LL LEE asas EEE E EEE Eek keka ka kek k k 12 3 3 Connect the POwer COVE coerent E GE W ra N a Winn E os Xd AGS LOG n he W Win te ST 12 Device p rati n Ze lt ar r r RR gerr 13 4 1 Starting the Device LLLLLL cece ene en ee ee eee seseeenee cues eseeesesuaesaeeaaesaecsaesseseseensesseessesaesaseseeeseeneseneeenes 13 4 2 Using the Ramp Button LLLL case ease aesseesaeesaecsaesaeeeaeensessesssesasesseseeessesnesenesenes 13 4 3 Turning the System OFF ccccccscsessvsiocsecicves stock si ana nes aya nya kun kun a KULA wala e k ak RAN o wilo Ha hu EE ESPRE Vu HA Vira v n aA WA K KAW S KI 13 4 4 Change Device Settings i iy yina sliolol ylay l a a e anan i E kod Vi ka a kek S KA WA aAa lA k TAS Eya k 14 r rrt r wyvWr ebb b s w w amp wVd 18 wa ww r r rrr ne recor ree torre rere reer teeter erreereerertrrre reece rere 19 Trrrzzo_ _e_ l l___reep mm r mm 19 6 2 Adding ONY GO sso aya ana kaya esos an disk s ya es aa a ae VR EE 19 Cleaning and Maintenance uu CEc asas kaka kk keka keka Kak K k kaka kek Kek Kek Kek Kak Ke KEK KHK KK KHK KAK KAKA KHK KA 20 7 1 Cleaning the Filler rociera eaa inai ae ka an ka e a a Dak ne Me kay n yend k kek 20 72 Cleaning zz aa a
26. ssions Class D IEC 61000 3 3 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 RESmart e BPAP 25 25A User Manual V2 1 Appendix A EMC Requirements cont Guidance and manufacturer s declaration electromagnetic 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 Immunity test IEC 60601 test Compliance Electromagnetic environment level level guidance 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Uz for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in Ur for5s 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in U7 for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in U7 for5s Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relat
27. t airport security stations there is a note on the bottom of the RESmart BPAP 25 25A stating that it is medical equipment It may help if you also take this manual with you when you travel User Buttons These buttons can be used to turn on off the system and change some of the system settings Handl e This handle is for lifting up the system P6 1 5 Glossary RESmart e BPAP 25 25A User Manual V2 1 The following terms appear throughout this manual Apnea Auto BPM CPAP EPAP IPAP LED OSA Ramp Rise Time RR S Spontaneous A condition marked by the cessation of spontaneous breathing 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 you do not inhale The differential pressure of IPAP and EPAP are presetted by home care provider While working in auto feature the device will automatically adjust the IPAP and EPAP if it detects a sleep apnea Breaths Per Minute A mode which the device output a constant positive pressure ignoring your inhalation or exhalation Expiratory Positive Airway Pressure Inspiratory Positive Airway Pressure Light Emitting Diode Obstructive Sleep Apnea A feature that may increase patient comfort when therapy is started The ramp feature reduces the pressure and then gra
28. th the accessories 7 3 Reordering Contact your home care provider to order accessories or Replacement filters Service The RESmart BPAP 25 25A 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 local regulations WARNING If you notice any unexplained changes in the performance of the RESmart BPAP 25 25A 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 your home care provider WARNING If the RESmart BPAP 25 25A malfunctions contact your home care provider immediately Never attempt to open the RESmart BPAP 25 25A s enclosure Repairs and adjustments must be performed by BMC authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage If necessary contact your local authorized dealer or BMC MEDICAL CO LTD for technical support and documents 7 4 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 7 5 Security Stations For convenience at security stations there is a note on the bottom of the RESmart BPAP 25 25A stating that it is medical equipment t may be helpful to brin
29. ur sleep Adjust the mask and headgear until you have a comfortable fit and there are no airflow leaks into your eyes 3 3 Connect the power cord Plug the socket end of the power cord into the AC inlet on the back of the RESmart BPAP 25 25A Plug the pronged end of the power cord into an electrical outlet System status will appear on the RESmart BPAP 25 25A screen P12 RESmart BPAP 25 25A User Manual V2 1 4 Device operation 4 1 Starting the Device Standby After power on system status will appear on display screen as below Work Mode S Mode 04 07 Pl P2 WorkMode 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 4 2 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 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 Press the Ramp button on the top of the RESmart BPAP 25 25A You can use the Ramp button as often as you wish during the night 4 3 Turning the System OFF Remove the mask and headgear Press th
30. vider will make the correct pressure settings according to your health care professionals prescription Several accessories are available to make your OSA treatment with the RESmart BPAP 25 25A as convenient and comfortable as possible To ensure that you receive the safe effective therapy prescribed for you use only BMC accessories The RESmart BPAP 25 25A is only used for single patient and must not be re used on another person This is to avoid the risk of cross infection RESmart e BPAP 25 25A User Manual V2 1 Introduction cont IMPORTANT Adverse Effects Read and understand the entire user manual before operating this system If you have any questions concerning the use of this system contact your home care provider or health care professional You should report unusual chest pain severe headache or increased breathlessness to your physician An acute upper respiratory tract infection may require temporary discontinuation of treatment The following side effects may arise during the course of therapy drying of the nose mouth or throat bloating ear or sinus discomfort eye irritation mask related skin irritations e chest discomfort RESmart 2 BPAP 25 25A User Manual V2 1 1 3 Warnings Cautions and Contraindications 1 3 1 Warnings A warning indicates the possibility for injury to the user or the operator WARNING o The instructions in this manual are not intended to supersede
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