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1 | User manual | Users Manual | 2.12 MiB | September 05 2022 |
User Manual PAP System(RXiBreeze PAP System) 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 14 Storage and Disposal................................................................................................................................31 14.1 Storage ........................................................................................................................................................31 15 Specification ................................................................................................................................................. 32 16 EMC Declaration ......................................................................................................................................... 34 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:
All installation operations, expansions, changes, modifications and repairs of this product are conducted by Resvent authorized personnel. All spare parts for repair, accessories, consumables are conducted by Resvent or the authorized personnel. The electrical installation of the relevant room complies with the applicable national standard and the manual requirements. The product is used in accordance with the instructions for use. IMPORTANT Read this entire guide before using the device. 2 Intended Use The RXiBreeze PAP Systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighting over 30kg (66lbs). It is for use in the home, hospital, or institutional environment. 3 Contraindications When assessing the relative risks and benefits of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cmH2O. In the event of certain fault conditions, maximum pressure 40 cmH2O is possible. Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
Severe coronary artery disease Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Caution should be used when prescribing CPAP therapy for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or Pneumothorax. The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Note: In either case above, it can only be determined by a competent physician whether to use CPAP device. 1 RXiBreeze PAP System User Manual User qualifications The person operating the device by the instruction in the users 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 users 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. 4 Safety Information WARNING: Indicate the possibility of injury to the user or the operator. CAUTION: Indicate the possibility of damage to the device. WARNING:
This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professionals instructions regarding the use of the device. This device is not intended for life support. A mask should not be used unless the device is turned on, otherwise, there is danger of suffocation. 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. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask exhalation port. However, when the device is not operating, enough fresh air will not be provided through the mask. If you are using a full-face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve. When using oxygen with this system, always make sure that the device is turned on and airflow generated before the oxygen supply is turned on. Always turn the oxygen supply off before the device is turned off, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire. Sources of oxygen must be located more than 1 m from the equipment to avoid the risk of fire and burns. Do not connect the device to an unregulated or high-pressure oxygen source. Oxygen must not be used while smoking or in the presence of an open flame. Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide. Do not use the device near a source of toxic or harmful vapors. Do not use this device if the room temperature exceeds 35C (95F). If the device is used at room temperatures warmer than 35C (95F), the temperature of the airflow may exceed 43C (109F). This could cause irritation or injury to your airway. The time required for the CPAP System to warm from the minimum storage temperature between uses until the CPAP System is ready for its intended use when the ambient temperature is 20 is at least 1h, and The time required for the CPAP System to cool from the maximum storage temperature between uses until the CPAP System is ready for its intended use when the ambient temperature is 20 (68F) is at least 1h. The device is not used beyond the specified temperature range. 2 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. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use. Contact your home care provider. Repairs and adjustments must be performed by Resvent-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage. Do not use any accessories, detachable parts, and materials not recommended by Resvent. Incompatible parts or accessories can result in degraded performance. The Health Industry Manufacturers Association recommends that a minimum separation of 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. The device should not be used while stacked or in close approximation to other non-approved devices. Use only approved cables and accessories. Misuse may affect EMC performance and should be avoided. Inspect the tubing for damage or wear. Discard and replace the tubing as necessary. Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if 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. This device is activated when the power cord is connected. For safe operation when using a humidifier, the humidifier must always be positioned below the breathing circuit connection at the mask. The humidifier must be level for proper operation. Nebulization or humidification can increase the resistance of breathing system filters and the operator must monitor the breathing system filter frequently for increased resistance and blockage to ensure the delivery of the therapeutic pressure. Please check whether there is water in the device before use. The maximum fill level is 290 mL. Failure to use a mask or accessory that minimizes re-breathing of carbon dioxide or permits spontaneous breathing can cause asphyxiation. Do not connect breathing tubes or accessories with any humidifier and ventilator that are not specified for use with these breathing tubes or accessories. Do not cover or heat the breathing tube with anything influent the patient end temperature. Do not use this device outside the specified ambient temperature range or humidity range. The humidity performance of the device can be compromised when used outside the specified ambient temperature range or humidity range. No modification of this equipment is allowed. Parts of the equipment are not serviced or maintained while in use with the patient. The PATIENT is an intended OPERATOR. The Patient can safely use therapy functions of the equipment and this equipment shall not be serviced or maintained while in use with the patient. 3 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. Allow the humidifier heater plate and water to cool down for approximately 15 minutes before removing the water tank. A burn may result from: touching the heater plate, coming in contact with the heated water, or touching the tank pan. CAUTION:
Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information, Contact your home care provider regarding EMC installation information. Mobile RF communications equipment can affect medical electrical equipment. Pins of connectors marked with the ESD warning symbol shall not be touched and connections shall not be made without special precautions. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), discharging ones body to the frame of the equipment or system or to earth. It is recommended that all individuals that will handle this device understand these precautionary procedures at a minimum as part of their training. Condensation may damage the device. If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating temperature range shown in the Specifications. Do not use extension cords with this device. Make sure the filter area on the side of the device is not blocked by bedding, curtains, or other items. Air must flow freely around the device for the system to work properly. Make sure the gas intake port on the side of the device is not blocked by bedding, curtains, or other items. Air must flow freely around the device for the system to work properly. Do not place the device directly onto carpet, fabric, or other flammable materials. Do not place the device in or on any container that can collect or hold water. A properly installed, undamaged filter is required for proper operation. Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning. Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the inlet filters as needed for integrity and cleanliness. 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 vehicles 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. When change the pressure setting, please consult your doctor. Do not position next to a curtain that blocks the flow of cooling air, thereby causing the equipment to overheat. 4 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. Ensure that the therapeutic pressure settings were determined for the patient individually with the configuration of the equipment to be used, including accessories. For multiple patients use, please use personal breathing tube and mask, do not use other. You should position the device far away your pets, pests or children when you use the device in home environment. In case you feel comfortless when you contact the device. You shall stop to use the device and contact your supplier immediately. Because it may cause allergic reactions. Please periodically reassess the setting(s) of the therapy for effectiveness. Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter. Empty the water tank before packing or moving the device!
FCC Caution:
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment. 3.This equipment should be installed and operated with minimum distance 20cm between the radiator& your body. 5 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. Separate collection for electrical and electronic equipment according to WEEE Directive 2012/19/EU Class II (double or reinforced insulation) Prevent solid foreign matters with a diameter of not less than 12.5mm and prevent vertical dripping when the shell is inclined at 15 Type BF Applied part 6 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. Unique device identifier Identifies unit has been registered as a radio device 6 System Contents Your CPAP system may include the following items:
CPAP Device Power Adapter Power Cord SD Card Flexible Tube: 19 mm or 15 mm tube Travel Bag 7 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. 8 RXiBreeze PAP System User Manual 7 System Overview
1 2 3 4 7 8 9 Device Feature Description Therapy On/Off Button Ramp Key Start and stopthe airflow for therapy. Activate the ramp feature during therapy. LCD Display screen This is the User interface for the therapy device. Control Dial 5 Water Tank Lock 6 Water Tank Air Outlet Port Power Inlet 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. This one piece removable water tank holds the water for humidification. Connect the tubing here. Connect the power cord here. SD card Access Door This door lifts open for access to SD card. 10 Air Inlet Port Inlet for room air. 11 Filter Cotton Cover Open the filter cotton cover to place or change the filter cotton. CPAP often is the best treatment for obstructive sleep apnoea. This CAPA system is an electronic-driven, microprocessor-controlled CAPA device that provides mechanical ventilation to a patient during use. This CPAP treatment involves a CPAP machine, which has four main parts:
A mask or other device that fits over the patients nose or patients nose and mouth. Straps keep the mask in place while the patient are wearing it. A tube that connects the mask to the machine's motor. A motor that blows air into the tube. CPAP machines have as well heated humidifiers. The PAP system consists of four parts depending on their functions: mechanical 9 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. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners). Note: When positioning the device, make sure that the power cable is accessible because removing power is the only way to turn off the device. CAUTION:
Make sure the filter area on the side of the device is not blocked by bedding, curtains, or other items. Air must flow freely around the device for the system to work properly. Do not place the device directly onto carpet, fabric, or other flammable materials. Do not place the device in or on any container that can collect or hold water. Do not contact the metal surface of the heater when pulling out the water tank. 7.2 Supplying AC Power Complete the following steps to operate the device using AC power:
1. Plug the socket end of the AC power cord (included) into the power supply (also included). 2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch. 10 RXiBreeze PAP System User Manual 3. Plug the power supply cords 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. Please stop using it and check the power status. Please do not contact with the DC in connector when it was broken. Please avoid arcing, wiggling, or dropping the power supply on hard surfaces. Please periodically inspect electrical cords and cables for damage or signs of wear and to discontinue use and replace if damaged. Please first check the DC connector could be used normal and not breaking free. Never place the power cord around the neck. Do not use any small parts to fix power cord in position as they might be accidentally swallowed. 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. 11 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. WARNING: Do not pull or stretch the tubing, this could result in circuit leaks. Inspect the tubing for damage or wear. Discard and replace the tubing as necessary. 3. Attach the headgear to the mask if necessary. For specific parameters and the correct use of the method, please refer to the mask manual. WARNING:
If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve. If multiple users share the same equipment, use low-resistance and bacteria-filtered cotton between the equipment and the tube. Note: The selected mask, breathing tube shall meet the performance requirements with good stability. The user should check the mask and tube for damage before each use. If necessary, place a bacterial filter in the air outlet of the unit and connect the tube. The use of bacterial filter cotton may affect the equipment work. However, the device can remain functional and be treated. Never place the respiration hose around the neck. Do not use any small parts to fix the respiration hose in position as they might be accidentally swallowed. Do not squash the respiration hose. 12 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. The fill line indicates 1/3 water level for safe operation. The fill line indicates 2/3 water level for safe operation. The fill line indicates the maximum water level for safe operation. CAUTION:
Use only room temperature distilled water or purified water. Do not fill the water tank above the maximum fill line. If the water tank is overfilled, water may leak into the therapy device, humidifier, or onto your furniture. Damage to the humidifier or therapy device may occur. Empty the water tank when the device is not in use. 13 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. Rotate the control dial to your desired menu option. 2. Press the control dial to select that setting. 3. Rotate the control dial to change the setting. 4. Press the control dial again to save the change. Note: The screens shown throughout this manual are examples for reference only. Actual screens may vary based upon device model and provider settings. 9 Operation This chapter describes basic operation and precautions associated with this device. 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). Note: Boot buzzer should be beep. If not, you cant use the equipment and then contact the supplier for inspection. 2. Put on your mask assembly. Refer to the instructions supplied with the mask. 3. Press the Therapy On/Off key on top of the device to turn on airflow and begin therapy. The screen will display to patient therapy clean interface (see Figure 2). 4. Make sure that no air is leaking from your mask. If necessary, adjust the mask and headgear until the air leak stops. 5. If you are using the device in a bed with a headboard, try placing the tubing over the headboard. This may reduce tension on the mask. 6. Press the Therapy On/Off key again to turn off therapy. Note:
1. When any power interruption (e.g., blackout) happens during therapy, the device will resume therapy mode if the power is restored within 60 minutes. 2. Please keep away from incense and candles avoiding catching fire during use. 9.2 Patient Menu Navigation Settings Patient Menu Navigation Setting including Standby interface shortcut operation.Therapy interface shortcut operation,Comfort Parameters setting interface,System setting interface. 9.2.1 Patient Standby Interface The Patient Standby Interface displays setup menus for the system main featuresand the icons to indicate the current enabled features. 14 RXiBreeze PAP System User Manual Figure1 Patient Standby Interface
Feature Description 1 Mode Display the current mode. 2 3 4 Enabled features Depending on setup, certain enabled therapy features will display here. Time Display the current time. 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. 5 Humidity 6 Mask fit Set humidifier level to enhance patient comfort of respiration. Option: Auto / OFF / 1-8 Note:
1.The humidity level only can be set when the water in humidifier exceeds the minimum water level for safe operation. Default: 3 2. The option Auto is not available in the RXiBreeze 20C. Mask fit feature allows you to check the fit of your mask prior to starting therapy. This is done by measuring the amount of leak. 7 8 9 Comfort Setting Press to enter Comfort setting interface. Press to enter Patient System Setting interface. Alarm Message Display the alarm messages. 15 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 Description The current therapy mode. Display the alarm messages. Humidity adjustment shortcut key and humidity level. Note: The humidity level is available when the humidity function is on. Background breathing dynamic diagram. The current therapy pressure. The therapy parameters monitoring during therapy. Ramp time dynamic diagram. Note: Only available when the Ramp function is on. Work status icon bar.
1 2 3 4 5 6 7 8 9.2.3 Patient Comfort Setting Press Interface. key in the Patient Standby interface to enter Patient Comfort Setting 16 RXiBreeze PAP System User Manual Figure3 Patient Comfort Setting Interface Icon Text Description 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 Note:
1. If the humidifier water level below the limit, Preheat function Default: OFF will be turned off automatically. 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 cmH2O-Setting pressure, 0.5 cmH2O increments. Default: 4 cmH2O the increase time from Ramp pressure to the setting Set therapy pressure. Option: 0-60 mins, 5 mins increments Default: 15 mins Note: if Ramp Time sets to 0 min, Ramp function will be off. function is on, Turn Auto Start function on or off. When the Auto Start therapy automatically if a breath with mask is detected. Option: On / OFF Turn Auto Stop function on or off. When the Auto Stop function is on, if the mask is removed more than 5 seconds, the therapy mode will stop. Option: On / OFF the system will start Default: ON Default: ON Preheat P Ramp Ramp Time Auto Start Auto Stop 17 RXiBreeze PAP System User Manual Icon Text Description IPR Tube Type Mask Type Set IPR (Intelligence Pressure Release) level. Option: OFF / 1-3 Default: 2 Set the Tube type. Option: 15 mm / 19 mm Default: 15 mm Set the Mask type. Option: Full Face / Nasal / Pillow Default: Nasal 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. Option: hPa / cmH2O Default: cmH2O Screen Brightness Language Adjust the Screen Brightness. Option: Auto / 1-3 Default: 2 Set the system interface language. Option:English / Spanish / French / German / Italian /
Portuguese Default: English. Note: Not all the languages are available, the optional items depend on software version. 18 Icon Text Energy Saving Date Date Format Time RXiBreeze PAP System User Manual 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 Set the system date. Note:
1. Date setting cant be earlier than the latest time of the Default: ON report in the device. 2. The system date is required to reset on the first time start up when the device is restored the factory default settings. Set the system date format. Option: YYYYMMDD / MMDDYYYY / DDMMYYYY Default: YYYYMMDD Set the system time. Note: time setting cant be earlier than the latest time of the report in the device. Alarm Clock Set the Alarm clock on or off, and the alarm time. Option: ON / OFF Default: OFF Key Tone Blue Network(optio nal) Set the switch key tone volume on or off. Option: ON / OFF Default: OFF Set the Blue Network function on or off. Option: ON / OFF Default: OFF WiFi
(optional) Set the WiFi function on or off. Option: ON / OFF Default: ON 19 RXiBreeze PAP System User Manual Icon Text Description Reminder 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 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. Default: OFF 2. Click OK to change the relevant accessories, and then no longer remind. 3. Click Ignore, the next day and next starting time will pop-up reminder box. About Display the device informaiton including system version, serial number, blower running time etc.. 9.2.5 Patient Report Menu Press info key in Patient Standby Interface to enter Patient Report Interface. Figure5 Patient Report Interface Item Description Period Usage AHI Set the time interval covered by the report. Options: daily (for recent 6 days) / 7 days / 14 days / 1 month / 3 months / 6 months / 1 year. Number of hours the device has been used in the selected period. The average apnea-hypopnea index in the selected period. 20 RXiBreeze PAP System User Manual Item Description Mask fit Humidify Use three stars for rating the leakage of mask in the selected period. The mask seal status is good. 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 therapy time. the total 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. To remove the SD card:
1. Stop therapy and open the SD card cover. 2. Push in the SD card to release it. Remove the SD card from the device. Place the SD card in the protective folder and send it to your care provider. Note 1. Do not remove the SD card from the device during therapy. 2. Do not use the SD card for any other purpose. 3. This device can use only manufacturer SD card. Please contact your supplier for purchasing. 9.2.7 Wireless transmission module 9.2.7.1 Wifi module connection There are 2 methods for the device to match WiFi networkconnect to the network through APP or connect to the network through the device. Method 1Connect to the network through APP 21 RXiBreeze PAP System User Manual
. Power on and start up the deviceenter the setting interfaceWifiset to On. Download ResAssist APPIOS system downloads from theApp storeAndroid system downloads from the Google Play.Register for an account after downloading is finished. Step 1use the mobile phone number or email to register a new account numberStep 2use the serial number of the device to register the user information, complete the two steps and then registered successfully. Log in ResAssist APP with the registered accountturn on the Bluetooth of your phoneclick the My icon in the lower right cornerWIFI settingsenter Wifi setting interface. Follow the steps on the APP interfacematch Wifi network to the deviceuntil Wifi connected successfully. Sign of Wifi connected successfullyResAssist APP showsConnection successfulor there is a icon on the standby interface to reminder the connection is successfulthe icon is Method 2Connect to the network through the device Power on and start up the deviceenter the setting interfaceWifiset to On. WiFi interface on the deviceclick searchsearch for the WiFi signals nearbyenter the WiFi list interface. Click on an available Wifienter the Wifi password input interfaceenter the correct password -- until Wifi connected successfully. Sign of connection successfulWifi status is connectedWifi status icon is 9.2.7.2 Usage of Wifi module The method for the device to connect WiFi network is through APP or through the device. Press the Therapy On/Off key on top of the device to turn on airflow and begin therapy. The device ventilation effectivelyPut on the mask and breathe normallyfor a period of time and then stop itWifi connect normally and begin to upload dataWifi icon signs an up arrow in the lower right corner. After data uploadlog in the Cloudview the treatment data uploaded from the cloud. 9.2.7.3 Wifi status sign Wifi Off Wifi OnWLAN hotspots unconnected Wifi OnWLAN hotspots connected but inaccessible to the sever Wifi connect normally Wifi upload data no Wifi sign
. 10 Device Alert There are 4 types of alerts described here:
Alert 0: Gray bottom white tips, no light, no sound, always display, disappear until the prompt condition not met. Alert 1: Orange bottom white tips, blue-ray flashing, with sound, always display, disappear until the prompt condition not met. 22 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. Alert Type Possible Cause Action Power Adapter with the wrong type, resulting in voltage is too high or too low 1. Insert SD card during data synchronization;
2. Input the configuration on the SD card. 1. No SD card in the device. 2. SD card has been removed. In Standby mode, SD card storage space only 200M Use the Power Adapter provided by Resvent. No action. Reinsert functional SD card. Replace the SD card or clean the data after export the data in the SD card. Input voltage is abnormal, please check!
Alert 2 SD card write/read underway, do not remove the SD card, do not cut off the power. Notification SD Card Removed. Notification Notification SD Card Full, Please replace the SD Card. SD card cant be written, please unlock and insert again. SD card error, please remove and insert again. Notification The SD card is read-only and cant be written. Remove the SD card, unlock and insert it again. Notification SD card failure, may be: 1.SD card cant read and write. 2.SD card read and write data errors. Remove SD Card, Reinsert or replace with a new card. Format the SD card in your computer and then insert it to device. Non-original Insert other device' SD card,continue using Notification card in non-service please format. mode. 23 RXiBreeze PAP System User Manual Alert Type Possible Cause Action Notification Software update. No action. Software update underway, Do not cut off the power!
System error code:
XXXX Please try to restart, please contact the supplier if repeat. The respiration tube expired, please replace. The water tank expired, please replace. Alert 2 Notification Notification The filter expired, please replace. Notification The mask expired, please replace. Notification 1. Pressure sensor failure, flow sensor failure, blower failure in therapy state; 2. Power board short-circuit 3. Humidifier heating circuit short-circuit In standby state, the usage time exceed the respiration tube setting service life. In standby state, the usage time exceed the water tank setting service life. In standby state, the usage time exceed the filter setting service life. In standby state, the usage time exceed the mask setting service life. Please try to restart, please contact the supplier if repeat. Click Confirm, replace the respiration tube. Click Confirm, replace the water tank. Click Confirm, replace the filter Click Confirm, replace the mask It is time for device maintenance, Please contact the service provider for device maintenance. Notification In standby state, the usage time exceed the setting device maintenance time. Click Confirm, contact the service provider for device maintenance. Apnea. Alert 1 Mask vent holes blocked. Alert 1 System Drying Notification Check the respiration tube or adjust therapy parameter setting. Check the mask. No action. An apnea is detected and exceeds the setting duration. Mask vent holes is blocked. The device generates a small flow to dry the system when it is the standby mode after 30 24 RXiBreeze PAP System User Manual Alert Type Possible Cause Action minutes usage with humidification. Alert1 RTC clock failure. RTC clock failure. Reports may not be saved. Note: Some alert messages depend on the device model. Please contact the supplier if you want reports be saved. 25 RXiBreeze PAP System User Manual 11 Troubleshooting If your device has the following problems in the usage, please try the following measures. If it cant be resolved, please contact the maintenance provider. Problem Possible Cause Action Nothing happens when you apply power to the device. The backlights on the keys do not light. Theres no power at the outlet or the device is unplugged. Air is leaking from Mask may be around my mask fitted incorrectly. 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 is connected correctly to the power supply and the power supply cord is securely connected to the devices power inlet. If the problem continues to occur, contact your home care provider. Return both the device and power supply to your provider, so they can determine if the problem is with the device or power supply. Make sure your mask is fitted correctly. See your mask user guide for fitting instructions or use the Mask Fit function to check your mask fit and I am getting a dry or blocked nose I am getting droplets of water on my nose, in the mask and air tubing My mouth is very dry and uncomfortable seal. Humidity level may be set too Adjust the Humidity Level. low. Humidity level may be set too Adjust the Humidity Level. high. Air may be Increase the Humidity Level. escaping through You may need a chin strap to keep your mouth. your mouth closed or a full face mask. 26 RXiBreeze PAP System User Manual Problem Possible Cause Action Air pressure in my mask seems too high
(it feels like I am getting too much air). Air pressure in my Ramp may be turned off. Use the Ramp Time option. 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). I have stopped Device blows a small amount of air in therapy, but the Device is cooling order to avoid condensation in the air device is still blowing down. tubing. It will stop automatically after a air. few minutes. The devices display The device has Unplug the device. Reapply power to is erratic (crash blank been dropped or the device. If the problem continues, or blue screen). mishandled. contact your home care provider. Water tank may not be assembled My water tank is correctly. leaking. Water tank may be damaged or cracked. Check for damage and reassemble the water tank correctly. Contact your care provider for a replacement. Key exception Program crashes Unplug the device. Reapply power to
(non-responsive or or key the device. If the problem continues, insensitive). misalignment. contact your home care provider. The knob is insensitive. Encoder is damaged Unplug the device. Reapply power to the device. If the problem continues, contact your home care provider. 12 Cleaning and Maintaining 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. Dust and dirt can also cause problems with the machine, making it more likely to break or need replacement. Please strictly follow the cleaning and disinfection process below:
27 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. Use a soft cloth slightly dipped in water to wipe and rinse the surface that was cleaned with soapy water in the previous step for 5 minutes, and repeat the above steps at least additional 2 times, three times in total. 3. Visual inspection the casing of the device, ensure there is no soil, stain or oil is seen. If there is determined not to be visually cleaned at the end of the cleaning steps. You should either repeat the relevant previous cleaning steps, so that a visible soiled device is not used again. 4. Wait about at lest 1 minutes for drying completely before plugging in the power cord. 2 Disinfection 1. After the cleaning procedure, use an 75% ethyl alcohol swab or cotton swab moistened with 75% ethyl alcohol to disinfect the device surface for about 5 minutes. 2. Repeat the above steps at least 3 times, then wipe surface dry with a clean cloth, and wait about 1 minute for drying after disinfection process. 3 Drying Allow sufficient time for the device to air dry completely. Note: Drying is not required after cleaning if disinfection is continued immediately. 4 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) 1 Cleaning 28 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. Soaking all the components in the solution,and through rinse each component in the rinsing water to ensure there are no air bubbles. Repeat the rinse procedure two additional times using fresh water for a total of three rinses. 5. Visual inspection to ensure there is no soil, stain or oil is seen. If there is determined not to be visually cleaned at the end of the cleaning steps. You should either repeat the relevant previous cleaning steps, so that a visible soiled device is not used again. 6. Shake the component to remove excess water, and allow the component to air dry rather out of direct sunlight. Note: Failure to clean the component as indicated may result in inadequate disinfection. 2 Disinfection WARNING: The disinfection process must be carried out after cleaning process. 1. After the cleaning procedure, immerse the component in a water bath, and make a solution of a 3% hydrogen peroxide, Soak the components in the solution at room temperature for at least 30 minuets. Rinse and agitate the component in the solution for 1 minutes 2. Soaking all the components in the solution,and rinse and agitate the component in a fresh water thoroughly for at least 3 times, 10 minutes per time and hang up to allow to air dry but out of direct sunlight or heat. 3. Perform a visual inspection of the device components. If any visible deterioration is apparent (cracking, crazing etc) discontinue use and contact your care provider or Resvent. 12.3 Cleaning Schedule To avoid prolonged exposure to dusty and humid environment, resulting in impaired performance and reliability, the user must clean the device regularly. The clean interval of the device and accessories, please refer the below table:
Interval Action 29 Interval Weekly RXiBreeze PAP System User Manual Action 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. The disinfection interval of the device and accessories, please refer the below table:
Interval Monthly Action Disinfect the water tank Disinfect the air outlet adaptor Disinfect air outlet of water tank 12.5 Installing/Replacing the Air Filter The device comes with a reusable air filter, it must be in place at all times when the device is operating. Please check the air filter every 1-3 months, clean or replace it if there are any holes or blockages by dirt or dust. Note: When you receive your device, if the filter cotton is not installed, you must install the filter cotton before using the device. To install or replace the air filter, please follow the below steps:
1. Open the air filter cover. 2. Place a filter cotton onto the air filter cover and then close it. 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. 2. Install the water tank back on the device. 3. Put the device and accessories in the travel bag. 30 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. 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. If the respiratory air humidifier is used as intended in accordance with these instructions for use, it does not require any maintenance. If you identify faulty parts during the function check, please contact your authorized dealer immediately. 14 Storage and Disposal 14.1 Storage 14.1.1 Storage Information Store the device under the prescribed ambient conditions. 14.1.2 Storing the therapy device. Switch off the therapy device. Disconnect the therapy device from the power supply. Clean the therapy device, components, and accessories. Store the therapy device, components, and accessories in a dry place. 14.2 Disposal Electronic waste Do not dispose of the product in the household waste. Consult an authorized, certified electronic waste recycling company for proper disposal. You can find out their address from your environmental officer or from your local council. The device packaging (cardboard box and inserts) can be disposed of as waste paper. Risk of injury if disposable items are reused!
Disposable items are only intended to be used once. Reused disposable items may be contaminated and/or not functions correctly and thus cause patient injury. 31 RXiBreeze PAP System User Manual 15 Specification Physical Dimension (L*W*H): 238*178*128 mm Weight: Approximately 1.60 kg Operating Environmental Temperature: 5~35 Relative Humidity: 10%~95% (non-condensing) Atmospheric Pressure: 70 kPa~106 kPa Storage Environmental Temperature: -25~70 Relative Humidity: 5%~95% (non-condensing) Atmospheric Pressure: 70 kPa~106 kPa Noise Value Sound pressure level Uncertainty Sound power level Uncertainty 30 dB(A) 2 dB(A) 38 dB(A) 2 dB(A) Standards Compliance IEC60601-12005+A12012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC60601-1-22014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests ISO 80601-2-702020 Medical electrical equipment Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment ISO 80601-2-74:2021 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment IEC60601-1-112015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - 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: 100-240V1.18-0.56A 50/60Hz 2A Max DC Output: 24 V Specified power supply: Shenzhen Longxc Power Supply Co.,LTD Model: LXCP61()-024300 AC Input: 100-24050/60Hz 1.5A Max DC Output: 24.0V 2.5 A 3.0A 32 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:2.55%) Pressure monitoring Accuracy: (2%*full scale reading + 4%*actual reading) Flow 19mm breathing tubing Measured pressure at the patient connection port
(cmH2O) Average flow at the patient connection port (L/min) 15mm breathing tubing Measured pressure at the patient connection port
(cmH2O) Average flow at the patient connection port (L/min) Test pressure (cmH2O) 4 8 12 16 20 2.9 7.1 11.0 15.1 19.1 154.3 146.4 135.7 125.3 114.1 2.9 6.9 10.8 14.8 18.7 141.4 132.7 124.2 114.3 85.4 Humidifier Water capacity: 290 ml (MAX Water Level) Humidity: >10 mg/L BTPS (Within the set pressure range) 33 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. The customer or the user of CPAP system can help prevent electromagnetic interference by maintaining a minimum distance between portable/mobile RF communications equipment (transmitters) and the CPAP system
(as recommended in form A-3) , according to the maximum output power of the communications equipment. Form A-1 Guidance and Declaration - Electromagnetic Emissions Emissions test Compliance Radiated emissions CISPR11 Group 1 Conducted emissions CISPR11 Harmonic emissions IEC 61000-3-2 Class B Class A Voltage fluctuations/flicker emissions IEC61000-3-3 Complies Electromagnetic environment guidance
The CPAP system 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. The CPAP system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 34 RXiBreeze PAP System User Manual Immunity test Form A-2 Guidance and Declaration - Electromagnetic Immunity Electromagnetic environment - guidance IEC60601test level Compliance level Electrostatic dischargeESD IEC61000-4-2 Contact8kV Air15 kV Contact8 kV Air15V Floors should be wood concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC61000-4-4 supply Power lines2 kV input/output lines1 kV supply Power lines2 kV input/output lines1 kV Mains power quality should be that of a typical commercial or hospital environment. Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 Power frequency 50/60Hz magnetic field IEC61000-4-8 Conduced RF IEC61000-4-6 line(s) to line(s) 1 kV line(s) line(s)1 kV to line(s) to earth 2 kV line(s) to earth 2 kV Mains power quality should be that of a typical commercial or hospital environment. 0%, 70%, 0% of UT 0% for 0.5 cycle 0% for 1 cycle 70% for 25 cycles 0% for 250 cycles 50Hz,60Hz 30A/m 50Hz:30A/m 60Hz:30A/m 150KHz to 80MHz 3Vrms ISM and amateur radio bands between 150KHz to 80MHz 6Vrms 3Vrms 6Vrms (in ISM and amateur radio bands) 80% AM at 1kHz. 35 Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the CPAP system, including cables, than the recommended separation distance Electromagnetic environment - guidance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances:
d=0.35 d=1.2 80MHz to 800MHz d=1.2 800MHzto 2.5GHz d=2.3 Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
RXiBreeze PAP System User Manual Immunity test IEC60601test level Compliance level Radiated RF IEC61000-4-3 80MHz to 2700MHz 10V/m
(rms) 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 Hz 36 RXiBreeze PAP System User Manual Form A-3.Recommended Separation Distance between Portable/Mobile RF Communications Equipment and the CPAP system. Separation distance in meters (m) according to frequency of the transmitter 150kHz~80MHz d=1.2 800MHz-2.5GHz d=2.3 80MHz-800MH z d=1.2 0.12 Rated maximum output power of transmitter(W) 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 0.38 1.2 3.8 12 37 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 professionals instructions regarding the use of the device. Disclosure of the information in this manual in any manner whatsoever without the written permission of Resvent. Release, amendment, reproduction, distribution, rental, adaptation or any other derivative work of this manual in any manner whatsoever without the written permission of 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. Contents of this manual are subject to change without prior notice. Limited Warranty Resvent warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications within the warranty period. 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. To exercise your rights under this warranty, contact your local authorized dealer or 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,Xinan Street, Baoan District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-23027370 Fax: 0086-755-23027370 http://www.resvent.com 1 3 5 Quick Operation Guide 2 Remove the humidier chamber. Open the lid, ll pour water to the maximum mark. 4 6 Lock the outlet onto back of device by turning outlet clockwise. Close the lid and insert the chamber back. 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.
1 | Label | ID Label/Location Info | 85.98 KiB | September 05 2022 |
(OY RXiBreeze PAP System resvent Model [#]: RXiBreeze 20A Input: 100-240V~,2A Max/1.5A Max,50/60Hz Output: 24VDC,2.5A/3.0A
GB-2B202632 Made in China STORAGE& TRANSPORT RANGES. OPERATING RANGES.
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-25C 5% 70.0kPa 5c 10%A ial Resvent Medical Technology Co., Ltd. BC601, BC602 , Gaoxingi Factory, District 67,Xing-
dong Community , Xinan Street, Baoan District, 518100 Shenzhen,PEOPLES REPUBLIC OF CHINA FCC ID: 2A6LY-0001
1 | Label location | ID Label/Location Info | 186.98 KiB | September 05 2022 |
j RXiBreoze PAP System gresvent J Medel) Rares 204 J Ino 10200V=28 Men AN EOE Resvont Medial Technology Co. Lid. a iin | See FCC ID : 2A6LY-0001 pe ZB |
of. OL 00 03 eR aaa OL 09 OS oY o Pos 39 GY Of 2 7001 S08 +8 ogataisa Cc) OF O06 Oe cee 09 y a OL 001 08 08 2 9,02 0 Ob OS 09 OL O8 6 Filan diashectinls ! inserts \ ; eal
1 | Cover Letter | Cover Letter(s) | 89.42 KiB | September 05 2022 |
2022-08-18 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2A6LY-0001 Product Name: RXiBreeze PAP System Request for Confidentiality Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential:
(List here the documents for which you are seeking confidentiality for example ) Schematics Block diagram Operation description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this By:
Title:
Aug.18, 2022 Signature Doris Liao Printed Registered Engineer On behalf of :
Resvent Medical Technology Co., Ltd. Telephone:
13635149336
frequency | equipment class | purpose | ||
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1 | 2022-09-05 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-09-05
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1 | Applicant's complete, legal business name |
Resvent Medical Technology Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0032305872
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1 | Physical Address |
BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin'an Street, Bao'an District
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1 |
BC601, BC602, Gaoxinqi Factory, District 67
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1 |
Shenzhen, N/A
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1 |
China
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app s | TCB Information | |||||
1 | TCB Application Email Address |
v******@nemko.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 | Grantee Code |
2A6LY
|
||||
1 | Equipment Product Code |
0001
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D**** L****
|
||||
1 | Title |
Registered Engineer
|
||||
1 | Telephone Number |
13635********
|
||||
1 |
d******@resvent.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | RXiBreeze PAP System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be colocated or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures, or as evaluated in this filing. End users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Shenzhen Huatongwei International Inspection Co.,
|
||||
1 | Name |
J****** L****
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 |
q******@szhtw.com.cn
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412 | 2462 | 0.0415 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2402 | 2480 | 0.0067 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC