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Resvent RXiBreeze User Manual
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Resvent RXiBreeze User Manual

Resvent RXiBreeze User Manual

Pap system
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User Manual
RXiBreeze PAP System

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Summary of Contents for Resvent RXiBreeze

  • Page 1 User Manual RXiBreeze PAP System...
  • Page 2 Contents 1 Welcome ................................. 1 2 Intend Use ................................1 3 Contraindications ..............................1 4 Safety Information ..............................2 5 Symbol ..................................6 6 System Contents ..............................9 7 System Overview ..............................9 7.1 Placing the Device ............................. 10 7.2 Supplying AC Power ..........................10 7.3 Connecting the Breathing Circuit .......................
  • Page 3 12.3.1 Cleaning (Weekly) ......................... 27 12.3.2 Disinfection (Monthly) ........................28 12.3.3 Drying ............................28 12.3.4 Inspection ............................28 12.4 Cleaning and Disinfection Process for (water tank, air outlet adaptor, air outlet of water tank) ....28 12.4.1 Cleaning (Weekly) ......................... 28 12.4.2 Disinfection (Monthly) ........................
  • Page 4 RXiBreeze PAP System User Manual 1 Welcome The RXiBreeze PAP Systems contains CPAP and APAP Modes. They are both continuous positive airway pressure devices. The RXiBreeze PAP Systems include the following models: RXiBreeze Ⅲ CPAP, RXiBreeze Ⅲ CPAP Pro, RXiBreeze Ⅲ APAP and RXiBreeze Ⅲ APAP Pro.
  • Page 5 ⚫ 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 RXiBreeze PAP System User Manual damaged. ⚫ To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. DO NOT immerse the device in any fluids. ⚫ Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture.
  • Page 7 When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running. Damage to the device may occur. ⚫ Only use a Resvent DC Power Cord and Battery Adapter Cable. Use of any other system may cause damage to the device. ⚫...
  • Page 8 RXiBreeze PAP System User Manual ⚫ When rain, lightning, earthquake, fire and other accidents occur in the natural environment, resulting in the failure of network transmission data, save the the data by using the TF card. ⚫ When accidental damage of physical media causes system failure, power failure, hardware failure and software failure, the protection of physical environment shall be strengthened and the use of equipment shall be controlled.
  • Page 9 RXiBreeze PAP System User Manual ➢ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. ➢ Consult the dealer or an experienced radio/TV technician for help. 5 Symbol The following symbols may appear on the device, power supply and accessories.
  • Page 10 RXiBreeze PAP System User Manual Symbol Reference Definition IEC 60529 Indicates the degree of protection provided by enclosure according to IEC 60529. ISO 15223-1 symbol Medical device 5.7.7 IEC 60417 Symbol Type BF Applied part (classification of medical electrical equipment, type B, 5333 as specified by IEC 60601-1).
  • Page 11 RXiBreeze PAP System User Manual Symbol Reference Definition 21 CFR 801.109 (b) U.S.Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by state law. Identifies unit has been registered as a radio device...
  • Page 12 RXiBreeze PAP System User Manual 6 System Contents RXiBreeze PAP Systems may include the following items: ⚫ Device ⚫ Power Adapter ⚫ Humidifier Note: If any of these items are missing, please contact your home care provider. 7 System Overview...
  • Page 13 RXiBreeze PAP System User Manual 7.1 Placing the Device Place the device on a firm, flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).
  • Page 14 RXiBreeze PAP System User Manual WARNING： ⚫ During use if the power cord is disconnected or a power failure, the device buzzer alert beeps. Please stop using it and check the power status. ⚫ Please do not contact with the DC in connector when it was broken.
  • Page 15 RXiBreeze PAP System User Manual ⚫ If the ambient temperature is too low, in order to avoid condensation, it is recommended to use the heated tube. Connect the other end of the tubing to the mask. For specific parameters and the correct method of using the tubing, please refer to the breathing tubing manual.
  • Page 16 RXiBreeze PAP System User Manual Press the water tank lock. Open the device lid. Remove the water tank from the device. Remove the water tank cover. Fill in only distilled or purified water up to the maximum water level. Insert the water tank cover back to the water tank.
  • Page 17 Each time you turn on the device, it will automatically run set by the user. 9.1 Starting the Device 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 4-1).
  • Page 18 RXiBreeze PAP System User Manual Press the Therapy On/Off key again to turn off therapy. Note: ⚫ When any power interruption (e.g., blackout) happens during therapy, the device will resume therapy mode if the power is restored within 60 minutes.
  • Page 19 RXiBreeze PAP System User Manual Comfort Press to enter Comfort setting interface. Setting Press to enter Patient System Setting interface. Alert Message Display the alert messages. Press confirm button to get more detail alert information. Refer to the Device Alert section to manage the alerts.
  • Page 20 RXiBreeze PAP System User Manual 9.2.3 Patient Report Menu Press info key in Patient Standby Interface to enter Patient Report Interface. Figure 4-3 Patient Report Interface Item Description Set the time interval covered by the report. Period Options: daily (for recent 6 days) / 7 days / 14 days / 1 month / 3 months / 6 months / 1 year.
  • Page 21 RXiBreeze PAP System User Manual 9.2.4 Mask Fit Click the button on the patient standby interface to enter the mask matching interface. Figure 4-4 Mask Fit Start the test immediately after entering the mask matching interface. Users can click to pause the test or click to start the test.
  • Page 22 RXiBreeze PAP System User Manual Item Description Set IPR (Intelligence Pressure Release) level. Option: OFF / 1-3 Default: 2 Set humidifier level to enhance patient comfort of respiration. Option: OFF / 1-3 Default: 1 Humidity Note: The humidity level only can be set when the water in humidifier exceeds the minimum water level for safe operation.
  • Page 23 RXiBreeze PAP System User Manual 9.2.6 Patient System Setting Press key in the Patient Standby interface to enter Patient Setting interface. Figure 4-6 Patient System Setting Item Description Set the pressure unit. P Unit Option: hPa / cmH Default: cmH Set the interface language of the system.
  • Page 24 9.2.7 TF Card The RXiBreeze PAP Systems comes with an TF 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 TF card to them for evaluation.
  • Page 25 RXiBreeze PAP System User Manual WiFi interface on the device, click “search”—search for the WiFi signals nearby—enter the WiFi list interface. Click on an available WiFi—enter the WiFi password input interface，enter the correct password -- until WiFi connected successfully. Sign of connection successful：WiFi status is connected，WiFi status icon is 9.3.2 WiFi Status Sign...
  • Page 26 RXiBreeze PAP System User Manual 10 Device Alert There are 4 types of alerts described here: ⚫ Alert 0: Gray background white tips, no light, no sound, always display, disappear until the prompt condition not met. ⚫ Alert 1: Orange background white tips, blue-ray flashing, with sound, always display, disappear until the prompt condition not met.
  • Page 27 RXiBreeze PAP System User Manual saved. card write/read Insert card during data underway, do not remove synchronization; Notification No action. the TF card, do not cut off 2. Input the configuration on the TF card. the power. Replace the TF card or...
  • Page 28 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 RXiBreeze PAP System User Manual seems too high (it feels like I off. am getting too much air). Air pressure in my mask Ramp be in seems too low (it feels like I Wait for air pressure to build up or turn Ramp Time off.
  • Page 30 RXiBreeze PAP System User Manual 12 Reprocessing NOTE: This device comply with cleaning and disinfection requirements of the ISO 17664:2017 standard. The machine needs to be cleaned and disinfected regularly so that these germs and contaminants do not grow inside of your equipment and make you sick.
  • Page 31 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. 12.4 Cleaning and Disinfection Process for (water tank, air outlet adaptor, air outlet of water tank) 12.4.1 Cleaning (Weekly)
  • Page 32 13 Maintenance RESVENT CPAP therapy device is designed to have useful service life and shelf life of 5 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.
  • Page 33 If you need to purchase new filter cotton, please contact your dealer. 13.3 Traveling with the Device Use the Resvent travel bag to carry the device and accessories when traveling. Please follow the below steps for packing: Remove the water tank from the device and pour out all water.
  • Page 34 RXiBreeze PAP System User Manual 14 Storage and Disposal 14.1 Storage 14.1.1 Storage Information Store the device under the prescribed ambient conditions. 14.1.2 Storage the therapy device ⚫ Switch off the therapy device. ⚫ Disconnect the therapy device from the power supply.
  • Page 35 RXiBreeze PAP System User Manual General requirements for basic safety and essential performance. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
  • Page 36 The RXiBreeze PAP Systems 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 RXiBreeze PAP Systems 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 Compliance Electromagnetic environment Immunity test IEC60601test level level guidance Floors should be wood、concrete or Electrostatic Contact：±8 ceramic tile. If floors are covered Contact：±8kV with synthetic material, the discharge（ESD）...
  • Page 38 RXiBreeze PAP System User Manual Compliance Electromagnetic environment Immunity test IEC60601test level level guidance Portable mobile communications equipment should be used no closer to any part of the 3Vrms RXiBreeze PAP Systems, including 150KHz to 80MHz 6Vrms (in ISM cables, than the recommended...
  • Page 39 RXiBreeze PAP System User Manual Compliance Electromagnetic environment Immunity test IEC60601test level level guidance 2450MHz 28V/m 9V/m PM at equipment marked with (rms) 217 Hz following symbol: 5240MHz, 5500MHz, 5785MHz 9V/m (rms)
  • Page 40 RXiBreeze PAP System User Manual Form A-3.Recommended Separation Distance between Portable/Mobile RF Communications Equipment and the RXiBreeze PAP Systems. Rated maximum output power of Separation distance in meters (m) according to frequency of the transmitter(W) transmitter 150kHz~80MHz 80MHz-800MHz 800MHz-2.5GHz d=1.2 d=1.2...
  • Page 41 During the warranty time, If the product fails to perform in accordance with the product specifications, Resvent will repair or replace – at its option – the defective material or part. Resvent will pay customary freight charges from Resvent to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration, water ingress, and other defects not related to material or workmanship.
  • Page 42 Resvent Medical Technology Co., Ltd. Registration address: BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community, Xin'an Street, Bao'an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Issue date: Apr.,2024 Tel: +86-755-23027370 © Resvent Medical Technology Co., Ltd. All rights Fax: +86-755-23027370 reserved http://www.resvent.com H-40101-000127-00-1.0...
  • Page 43 Quick Operation Guide...