Resvent RXiBreeze User Manual
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Resvent RXiBreeze User Manual

Pap systems
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User Manual
PAP System(RXiBreeze PAP System)

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Summary of Contents for Resvent RXiBreeze

  • Page 1 User Manual PAP System(RXiBreeze PAP System)

  • Page 2: Table Of Contents

    Contents 1 Welcome ................................1 2 Intended Use ..............................1 3 Contraindications ............................1 4 Safety Information............................2 5 Symbol .................................6 6 System Contents ..............................7 7 System Overview ............................. 9 8 Navigating the Device Screens ........................14 9 Operation .................................14 10 Device Alert ..............................22 11 Troubleshooting ............................26 12 Cleaning and Maintaining........................27 13 Maintenance ..............................31...

  • Page 3: Welcome

    RXiBreeze PAP System User Manual 1 Welcome The RXiBreeze PAP Systems contain CPAP and APAP Modes. They are both continuous positive airway pressure devices. The RXiBreeze PAP Systems include the following models: RXiBreeze20C,RXiBreeze 20A. Responsibility on the Manufacturer Party Resvent is responsible for the effects on safety, reliability and performance of this product, only if: ...

  • Page 4: Safety Information

     The device must be used only with the masks and accessories recommended by Resvent. The masks and accessories are validated for use with Resvent devices.  The exhalation port(s) associated with the mask should never be blocked. The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask.
  • Page 5 16cm be maintained between a wireless phone and a pacemaker to avoid potential interference with the pacemaker.  Use only power cords supplied by Resvent for this device. Use of power cords not supplied by Resvent may cause overheating or damage to the device and may result in increased emissions or decreased immunity of the equipment or system.
  • Page 6  Always ensure that the DC power cord securely fits into your therapy device prior to use. Contact your home care provider or Resvent to determine if you have the appropriate DC cord for your specific therapy device.  When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running.
  • Page 7 RXiBreeze PAP System User Manual  Do not block the gas INTAKE PORT, thereby interfering with therapy.  Please follow the local regulation when disposing of the device  The proper placement and positioning of the MASK on the face is critical to the consistent operation of this equipment.

  • Page 8: Symbol

    RXiBreeze PAP System User Manual 5 Symbol The following symbols may appear on the device, power supply and accessories. Symbol Definition Manufacturer Date of Manufacture(YYYY-MM-DD) Country of manufacture:CN(China). Model number Serial number Direct current. Temperature limit Humidity limitation Atmospheric pressure limitation It is mandatory action to read the Follow instructions for use.

  • Page 9: System Contents

    RXiBreeze PAP System User Manual Medical device The device is not suitable for use in MRI environment Respiratory air humidifier is heated. Do not touch the element Therapy On/Off Button (Starts and stops the airflow for therapy) This way up at transport and storage...
  • Page 10 RXiBreeze PAP System User Manual User Manual  Nasal mask or full face mask  Note: If any of these items are missing, please contact your home care provider.

  • Page 11: System Overview

    RXiBreeze PAP System User Manual 7 System Overview Device Feature Description Therapy On/Off Start and stopthe airflow for therapy. Button Ramp Key Activate the ramp feature during therapy. LCD Display screen This is the User interface for the therapy device.
  • Page 12 RXiBreeze PAP System User Manual structure, pneumatic system, hardware system and software system. Each part is composed of multiple functional modules. Pneumatic system Figure 1 shows the pneumatic system, which includes four parts: gas supplies, humidifier and breathing system. Figure 1-Pneumatic system 7.1 Placing the Device...
  • Page 13 7.3 Connecting the Breathing Circuit To use the system, you need the following accessories in order to assemble the recommended breathing circuit: Resvent interface (nasal mask or full face mask) with integrated exhalation port.  Resvent flexible tubing, 1.8 m.
  • Page 14 RXiBreeze PAP System User Manual To connect your breathing circuit to the device, please follow the below steps: 1. Install the connector to the back of the device, and connect the tubing with it. Note: If you are using a standard tube (not shown) instead of a heated tube, simply slide the tubing over the air outlet port on the therapy device.
  • Page 15 RXiBreeze PAP System User Manual 7.4 Water-filling Operation 1. Remove the water tank from the device. 2. Open the water tank lid, fill it with water up to the maximum fill line. 3. Lock the water tank lid. 4. Install the water tank on the device.

  • Page 16: Navigating The Device Screens

    Each time you turn on the device, it will automatically run set by the user. 9.1 Starting the Device 1. Ensure power is supplied to the device. The first screen to display will be the Resvent logo, within 5 second followed by the patient standby screen (See Figure 1).
  • Page 17 1.The humidity level only can be set when the water in humidifier exceeds the minimum water level for safe operation. 2. The option Auto is not available in the RXiBreeze 20C. Mask fit Mask fit feature allows you to check the fit of your mask prior to starting therapy.
  • Page 18 RXiBreeze PAP System User Manual 9.2.2 Patient Therapy Interface When the therapy starts, the screen will switch to the Patient Therapy Interface, which displays the therapy parameters monitoring during therapy (See Figure2). The displayed parameters depend on the current therapy mode.
  • Page 19 2. If humidifier function is turned off, Preheat function will be disable. 3. Preheat function is not available in the RXiBreeze 20C. Set the starting pressure of Ramp. Setting Range: 3 cmH O-Setting pressure, 0.5 cmH P Ramp increments.
  • Page 20 RXiBreeze PAP System User Manual Icon Text Description Set IPR (Intelligence Pressure Release) level. Option: OFF / 1-3 Default: 2 Set the Tube type. Tube Option: 15 mm / 19 mm Default: 15 mm Type Set the Mask type. Mask...
  • Page 21 RXiBreeze PAP System User Manual Icon Text Description Set the Energy Saving function on or off. When Energy Saving is on, the screen will be turned off automatically if there is no operation within 3 minutes in standby mode, or 30 seconds in therapy mode. If Energy Energy Saving Saving is off, the screen is always on.
  • Page 22 RXiBreeze PAP System User Manual Icon Text Description Set the Reminder type and time. You can turn on or off the different type of reminders, including: Mask, Filter, Water tank, Tube, Clinic, Maintenance interval. Option: ON / OFF Default: OFF Note: 1.
  • Page 23 9.2.6 SD Card The RXiBreeze PAP Systems comes with an SD card already inserted in the device to store therapy information for the home care provider. Your home care provider may ask you to send the SD card to them for evaluation.

  • Page 24: Device Alert

    RXiBreeze PAP System User Manual ➊Power on and start up the device，enter the setting interface—Wifi—set to On. ➋Download “ResAssist” APP，IOS system downloads from the“App store”，Android system downloads from the “Google Play”.Register for an account after downloading is finished. Step 1，use the mobile phone number or email to register a new account number；Step 2，use the serial number of the device to register the user information,...
  • Page 25 RXiBreeze PAP System User Manual Alert 2: Red bottom white tips, blue-ray flashing, with sound, exclusive alarm until  the user opens the alert to confirm or press the Therapy On/Off key. Notification: White reminder message, no light, no sound, after the ...
  • Page 26 RXiBreeze PAP System User Manual Alert Type Possible Cause Action Software update underway, Do not Notification Software update. No action. cut off the power! 1. Pressure sensor System error code: failure, flow sensor XXXX Please try to failure, blower failure in...
  • Page 27 RXiBreeze PAP System User Manual Alert Type Possible Cause Action minutes usage with humidification. RTC clock failure. Please contact the Reports may not be Alert1 RTC clock failure. supplier if you want saved. reports be saved. Note: Some alert messages depend on the device model.

  • Page 28: Troubleshooting

    RXiBreeze PAP System User Manual 11 Troubleshooting If your device has the following problems in the usage, please try the following measures. If it can’t be resolved, please contact the maintenance provider. Problem Possible Cause Action Check the outlet and verify that the device is properly plugged in.

  • Page 29: Cleaning And Maintaining

    RXiBreeze PAP System User Manual Problem Possible Cause Action Air pressure in my Ramp may be mask seems too high Use the Ramp Time option. (it feels like I am turned off. getting too much air). Air pressure in my...
  • Page 30 Inspection Perform a visual inspection of the device casing. If any visible deterioration is apparent (cracking, crazing etc) discontinue use and contact your care provider or Resvent. 12.2 Cleaning and Disinfection Process and Schedule for (Water tank, air outlet adaptor, air outlet of water tank)
  • Page 31 RXiBreeze PAP System User Manual Remove all detachable parts from the device. Make a solution of a neutral detergent (such as, soapsuds) and water. Soaked all components for about 5-10 minutes. Agitate the component in the cleaning solution to ensure there are no air bubbles Clean the inside and outside of all components with a soft bristle brush while soaking in a detergent solution.
  • Page 32 If replacing, remove the old filter cotton and then place a new one. 12.6 Traveling with the Device Use the Resvent travel bag to carry the device and accessories when traveling. Please follow the below steps for packing: 1. Remove the water tank from the device and pour out all water.

  • Page 33: Maintenance

    13 Maintenance RESVENT CPAP therapy device is designed to have a useful service life of 10 years. If the therapy device is used as intended in accordance with the instructions for use, it does not require any maintenance within this period. If the therapy device is used beyond this period, we recommend having it checked by an authorized dealer.

  • Page 34: Specification

    - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Electrical Specified power supply: Resvent Medical Technology Co., Ltd. Model: MDA60-220S24-W1 AC Input: 100-240V～1.18-0.56A 50/60Hz 2A Max DC Output: 24 V⎓2.5 A Specified power supply: Shenzhen Longxc Power Supply Co.,LTD...
  • Page 35 RXiBreeze PAP System User Manual Safety Specifications Class II Type BF Ingress Protection: IP22 Air filter Air filter: Filter Efficiency: >75% (7 micron dust) Pressure Setting Range: 4-20 cmH Max Single Fault Steady Pressure: 40 cmH Static Pressure Accuracy: ±0.5 cmH O (Expanded uncertainty:1.87%)

  • Page 36: Emc Declaration

    RXiBreeze PAP System User Manual 16 EMC Declaration Essential Performance： CPAP mode: work pressure 10 cmH The CPAP system is intended for use in the specified electromagnetic environment listed in form A-1, A-2 and A-3. The customer or the user of CPAP system should assure that it is used in such an environment as described below.
  • Page 37 RXiBreeze PAP System User Manual Form A-2 Guidance and Declaration - Electromagnetic Immunity IEC60601test Compliance Electromagnetic Immunity test level level environment - guidance Floors should be wood、 concrete or ceramic tile. Electrostatic Contact：±8kV Contact：±8 kV If floors are covered with discharge（ESD）...
  • Page 38 RXiBreeze PAP System User Manual IEC60601test Compliance Electromagnetic Immunity test level level environment - guidance calculated from the equation appropriate for the frequency of the transmitter. Recommended � separation distances: � d=0.35 d=1.2 80MHz to � 80MHz to 800MHz： 2700MHz 10V/m d=1.2...
  • Page 39 RXiBreeze PAP System User Manual Form A-3.Recommended Separation Distance between Portable/Mobile RF Communications Equipment and the CPAP system. Rated maximum output Separation distance in meters (m) according to power of transmitter(W) frequency of the transmitter � � 150kHz~80MHz 80MHz-800MH 800MHz-2.5GHz �...
  • Page 40 Resvent is strictly forbidden. All information contained in this manual is believed to be correct. Resvent shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
  • Page 41 Issue date: Decembe., 2020 © Resvent Medical Technology Co., Ltd. All rights reserved H-4000-000002-00 V5.1 Contact information Resvent Medical Technology Co., Ltd. BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-23027370 Fax: 0086-755-23027370 http://www.resvent.com...
  • Page 42 Quick Operation Guide Open the lid, fill pour water to the Remove the humidifier chamber. maximum mark. Close the lid and insert the Lock the outlet onto back of chamber back. device by turning outlet clockwise. Connect one side of the tube to Connect the power supply to the the air outlet and mask at the device.

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