User Manual PAP System(RXiBreeze PAP System)
Contents 1 Welcome .............................................................................................................................................................1 2 Intended Use .....................................................................................................................................................1 3 Contraindications ............................................................................................................................................
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.
RXiBreeze PAP System User Manual User qualifications The person operating the device by the instruction in the user’s manual is referred as the “user”. In contrast, a “patient” is the person receiving the therapy. Always perform all the operating steps in accordance with the user’s manual. Some lay person can receive specified professional training about how to use the device including all related to accessories from your dealer or the manufacturer.
RXiBreeze PAP System User Manual Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device. Contact your health care professional if symptoms of sleep apnea recur.
RXiBreeze PAP System User Manual Please first check the breathing tube is connected correctly to avoid strangulation risk due to breathing tube and hoses when used. Do not pull or stretch the tubing. This could result in circuit leaks. If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed in-line between the device and the circuit tubing to prevent contamination.
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. Please check that the compatibility of the equipment and all of the parts and accessories used to connect to the patient before use.
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 Follow instructions for use. It is mandatory action to read the instructions for use.
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 Do not roll Fragile, handle with care Keep dry Keep away from sunlight Stacking limit by 8 Recyclable materials 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.
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.
RXiBreeze PAP System User Manual 7 System Overview # Device Feature Description 1 Start and stopthe airflow for therapy. 2 Therapy On/Off Button Ramp Key 3 LCD Display screen This is the User interface for the therapy device. 4 Control Dial 5 Water Tank Lock Turn the dial to scroll between options on the screen. Press the dial to choose the option. Press the water tank lock to remove the water tank.
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 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.
RXiBreeze PAP System User Manual 3. Plug the power supply cord’s connector into the power inlet on the side of the device. 4. Verify that the plug at the side of the device, at the power supply, and at the electrical outlet are fully inserted. 5. When turning off the device Press Therapy On/Off Button, the device will stop work. 6. Disconnecting Network power source. WARNING: During use if the power cord is disconnected or a power failure, the device buzzer alarm beeps.
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. 2. Connect the tubing to the mask. For specific parameters and the correct use of the method, please refer to the breathing hose manual.
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. ➊The fill line indicates 1/3 water level for safe operation. ➋The fill line indicates 2/3 water level for safe operation. ➌The fill line indicates the maximum water level for safe operation.
RXiBreeze PAP System User Manual 8 Navigating the Device Screens The User Interface (UI) on this device allows you to adjust the device settings and view information about your therapy. The UI is comprised of the display screen and the control dial. Rotate the control dial in either direction to scroll through the menu options on the display screen. Note: The screen does not support touch operations. You must use the control dial to navigate the device menu. To adjust a setting: 1.
RXiBreeze PAP System User Manual Figure1 Patient Standby Interface # Feature Description 1 Mode Display the current mode. 2 Enabled features Depending on setup, certain enabled therapy features will display here. 3 Time Display the current time. 4 Patient Sleep Quality Report Display the patient sleep quality report and the options for period of the report are: daily (recent 6 days) / 7 days / 14 days / 1 month / 3 months / 6 months / 1 year.
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. Figure2 Patient Therapy Interface # 1 Description The current therapy mode. 2 Display the alarm messages. 3 Humidity adjustment shortcut key and humidity level.
RXiBreeze PAP System User Manual Figure3 Patient Comfort Setting Interface Icon Text Description Preheat Turn Preheat function on or off. When the Preheat is on, the humidifier starts preheating in the standby mode and the maximum preheating time is 30 minutes. In the therapy mode, the preheating stops. Option: ON / OFF Default: OFF Note: 1. If the humidifier water level below the limit, Preheat function will be turned off automatically. 2.
RXiBreeze PAP System User Manual Icon Text Description IPR Set IPR (Intelligence Pressure Release) level. Option: OFF / 1-3 Default: 2 Tube Type Set the Tube type. Option: 15 mm / 19 mm Default: 15 mm Set the Mask type. Option: Full Face / Nasal / Pillow Default: Nasal Mask Type 9.2.4 Patient System Setting Press key in the Patient Standby interface to enter Patient Setting interface. Figure4 Patient Setting Interface Icon Text Description Pressure Unit Set the pressure unit.
RXiBreeze PAP System User Manual Icon Text Energy Saving Date 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 Saving is off, the screen is always on. Option: ON / OFF Default: ON Set the system date. Note: 1. Date setting can’t be earlier than the latest time of the report in the device. 2.
RXiBreeze PAP System User Manual Icon Text Description Reminder About 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. Set the date of reminder, will pop-up reminder box first time to enter standby mode in the day of setting reminder day. 2. Click OK to change the relevant accessories, and then no longer remind. 3.
RXiBreeze PAP System User Manual Item Description Mask fit Use three stars for rating the leakage of mask in the selected period. The mask seal status is good. Humidify The mask needs adjustments. Use three stars for rating the usage time of humidifier in the selected period. Humidifier has been used more than 60% of the total therapy time. Humidifier has been used less than 5% of the total therapy time. 9.2.
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, complete the two steps and then registered successfully.
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 corresponding process, the message automatically disappears. Alert Summary Table: The following table summarizes the alerts.
RXiBreeze PAP System User Manual Alert Type Possible Cause Action Software update underway, Do not cut off the power! Notification Software update. No action. System error code: XXXX Please try to restart, please contact the supplier if repeat. Alert 2 The respiration tube expired, please replace. Notification The water tank expired, please replace. Notification The filter expired, please replace. Notification The mask expired, please replace.
RXiBreeze PAP System User Manual Alert Type Possible Cause Action minutes usage with humidification. RTC clock failure. Reports may not be saved. Alert1 RTC clock failure. Note: Some alert messages depend on the device model. 25 Please contact the supplier if you want reports be saved.
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. Make sure there is power available at the outlet. Make sure the AC power cord Nothing happens when you apply power to the device. The backlights on the keys do not light.
RXiBreeze PAP System User Manual Problem Air pressure in my mask seems too high (it feels like I am getting too much air). Possible Cause Action Ramp may be Use the Ramp Time option. turned off. Air pressure in my mask seems too low Ramp may be in Wait for air pressure to build up or turn (it feels like I am not progress. Ramp Time off. getting enough air).
RXiBreeze PAP System User Manual 12.1 Cleaning and Disinfection Process and Schedule for Device Surface 1 Cleaning WARNING: 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. 1. Please power off and unplug of the device, and throughout cleaning the casing of the device to removal of soil, stain or oil by using a soft cloth slightly dampened with neutral detergent (such as, 5% soapsuds) 2.
RXiBreeze PAP System User Manual 1. Remove all detachable parts from the device. Make a solution of a neutral detergent (such as, soapsuds) and water. 2. Soaked all components for about 5-10 minutes. Agitate the component in the cleaning solution to ensure there are no air bubbles 3. Clean the inside and outside of all components with a soft bristle brush while soaking in a detergent solution. Pay particular attention to all crevices and cavities 4.
RXiBreeze PAP System User Manual Interval Action Weekly Clean the device casing. Clean the water tank, air outlet adaptor, air outlet of water tank 12.4 Disinfection Schedule To avoid germs and allergens growing inside of your equipment and making you sick, the user must disinfect the device regularly.
RXiBreeze PAP System User Manual 12.7 Device Maintenance No regular maintenance is required. If you notice abnormal running of the device, abnormal sounds, device or power supply drops from the tabletop, or have mistakenly operated, liquid has entered the device and the cover has ruptured, disconnect the power and contact your supplier. 13 Maintenance RESVENT CPAP therapy device is designed to have a useful service life of 10 years.
RXiBreeze PAP System User Manual 15 Specification Physical Dimension (L*W*H): 238*178*128 mm Weight: Approximately 1.
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 cmH2O Max Single Fault Steady Pressure: 40 cmH2O Static Pressure Accuracy: ±0.5 cmH2O (Expanded uncertainty:1.87%) Dynamic Pressure Accuracy: ±1cmH2O (Expanded uncertainty:2.
RXiBreeze PAP System User Manual 16 EMC Declaration Essential Performance： CPAP mode: work pressure 10 cmH2O. 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. The CPAP system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled.
RXiBreeze PAP System User Manual Form A-2 Guidance and Declaration - Electromagnetic Immunity IEC60601test Compliance Electromagnetic Immunity test level level environment - guidance Contact：±8 kV Air：±15V Floors should be wood、 concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
RXiBreeze PAP System User Manual Immunity test IEC60601test level Compliance level 80MHz to 2700MHz 10V/m (rms) Radiated RF IEC61000-4-3 385MHz 27V/m (rms) 450MHz 28V/m (rms) 710MHz, 745MHz, 780MHz 9V/m (rms) 810MHz, 870MHz, 930MHz 28V/m (rms) 1720MHz, 1845MHz, 1970MHz 28V/m (rms) 2450MHz 28V/m (rms) 5240MHz, 5500MHz, 5785MHz 9V/m (rms) 10V/m, 80% AM at 1kHz 27V/m PM at 18Hz 28V/m FM ± 5 kHz deviation at 1kHz sine 9V/m PM at 217 Hz 28V/m PM at 18Hz 28V/m PM at 217 Hz 28V/m PM at 217 Hz 9V/m PM at 217
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 d=1.2 � z d=2.3 � d=1.2 � 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
Statement Resvent Medical Technology Co., Ltd.（hereinafter called "Resvent") owns the intellectual property rights to this manual. Resvent intends to maintain the contents of this manual and confidential information. This manual serves as a reference. The instruction in this manual is not intended to supersede the health care professional’s instructions regarding the use of the device. Disclosure of the information in this manual in any manner whatsoever without the written permission of Resvent.
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.
Quick Operation Guide 2 1 Open the lid, fill pour water to the Remove the humidifier chamber. maximum mark. 3 4 Close the lid and insert the Lock the outlet onto back of chamber back. device by turning outlet clockwise. 5 6 Connect one side of the tube to Connect the power supply to the the air outlet and mask at the device. Fit mask and press start other end. button to initiate therapy.
