The Resvent RXiBreeze PAP System is a medical device designed to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66lbs). It is intended for use in the home, hospital, or institutional environment. The system offers both continuous positive airway pressure (CPAP) and APAP modes.
Function Description
The RXiBreeze PAP System provides therapy by delivering pressurized air through a mask to keep the patient's airway open. It features a user-friendly interface with an LCD display and a control dial for navigation. Key functions include:
- Therapy On/Off: Starts and stops the airflow for therapy.
- Ramp Key: Activates the ramp feature, which gradually increases pressure to the prescribed level, allowing the user to fall asleep more comfortably.
- LCD Display Screen: Provides the user interface for therapy settings and information.
- Control Dial: Used to scroll between options on the screen and select choices.
- Water Tank Lock: Secures the water tank.
- Water Tank: Holds water for humidification.
- Air Outlet Port: Connects to the tubing.
- Power Inlet: Connects to the power cord.
- SD Card Access Door: Provides access for the SD card, which stores therapy data.
- Air Inlet Port: Inlet for room air.
- Filter Cotton Cover: Allows access to change the filter cotton.
The device also incorporates a pneumatic system with a blower, mufflers for noise reduction, and a humidifier.
Important Technical Specifications
- Physical Dimensions (L*W*H): 238*178*128 mm
- Weight: Approximately 1.60 kg
- Operating Environmental Temperature: 5°C~35°C
- Operating Environmental Relative Humidity: 10%~95% (non-condensing)
- Operating Environmental Atmospheric Pressure: 70 kPa~106 kPa
- Storage Environmental Temperature: -25°C~70°C
- Storage Environmental Relative Humidity: 5%~95% (non-condensing)
- Storage Environmental Atmospheric Pressure: 70 kPa~106 kPa
- Power Supply: Resvent Medical Technology Co., Ltd. Model: MDA60-220S24-W1
- AC Input: 100-240V~1.18-0.56A 50/60Hz 2A Max
- DC Output: 24 V-2.5 A
- Power Supply (Shenzhen Longxc Power Supply Co.,LTD): Model: LXCP61(II)-024300
- AC Input: 100-240~50/60Hz 1.5A Max
- DC Output: 24.0V~3.0A
- Ingress Protection: IP22
- Air 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)
- Humidifier Water Capacity: 290 ml (MAX Water Level)
- Humidity: >10 mg/L BTPS (Within the set pressure range)
- Service Life: 10 years (if therapy device is used as intended in accordance with instructions for use)
Usage Features
The RXiBreeze PAP System offers several features to enhance user comfort and therapy effectiveness:
- Patient Standby Interface: Displays current mode, enabled features, time, patient sleep quality report, humidity level, mask fit status, comfort settings, and system settings.
- Patient Therapy Interface: Shows the current therapy mode, alarm messages, humidity adjustment shortcut key, background breathing dynamic diagram, current therapy pressure, and therapy parameters being monitored.
- Comfort Settings:
- Preheat: Warms the humidifier water before therapy. The maximum preheating time is 30 minutes.
- P Ramp: Sets the starting pressure of the ramp.
- Ramp Time: Adjusts the duration of the ramp (0-60 mins, 5 mins increments).
- Auto Start: Automatically starts therapy when a breath with a mask is detected.
- Auto Stop: Automatically stops therapy when the mask is removed for more than 5 seconds.
- IPR (Intelligence Pressure Release): Level 1-3.
- Tube Type: Sets the tube diameter (15 mm or 19 mm).
- Mask Type: Sets the mask type (Full Face / Nasal / Pillow).
- Patient System Setting: Allows adjustment of pressure unit, screen brightness, language, WiFi, energy saving, date, date format, time, alarm clock, key tone, and Blue Network (optional).
- Patient Report Interface: Provides a summary of therapy data including usage hours, AHI (Apnea-Hypopnea Index), mask fit, and humidity.
- SD Card: Stores therapy information for home care providers.
- Wireless Transmission Module (WiFi): Allows connection to the network through an APP for data management.
- Device Alerts: Provides notifications for various issues such as input voltage abnormalities, SD card errors, software updates, system errors, expired components (respiration tube, water tank, filter, mask), and maintenance reminders.
Maintenance Features
Regular cleaning and maintenance are crucial for the device's performance and longevity.
- Cleaning:
- Device Surface: Clean with a soft cloth lightly dampened with neutral detergent (such as 5% soapsuds).
- Water Tank: Disassemble and clean with a soft bristled brush and detergent solution. Rinse and air dry.
- Air Outlet Adaptor: Clean with a soft bristled brush and detergent solution. Rinse and air dry.
- Air Outlet of Water Tank: Clean with a soft bristled brush and detergent solution. Rinse and air dry.
- Disinfection:
- Device Surface: Wipe with a 75% ethyl alcohol swab or cotton swab moistened with 75% ethyl alcohol.
- Water Tank: Immerse in a water bath with a 3% hydrogen peroxide solution for at least 30 minutes. Rinse and air dry.
- Air Outlet Adaptor: Immerse in a water bath with a 3% hydrogen peroxide solution for at least 30 minutes. Rinse and air dry.
- Air Outlet of Water Tank: Immerse in a water bath with a 3% hydrogen peroxide solution for at least 30 minutes. Rinse and air dry.
- Inspection: Perform a visual inspection of the device casing for any visible deterioration.
- Replacing the Air Filter: The device comes with a reusable air filter. Check the air filter every 1-3 months and clean or replace it if there are any holes or blockages.
- Maintenance Interval:
- Weekly: Clean the device casing, water tank, air outlet adaptor, and air outlet of water tank.
- Monthly: Disinfect the water tank, air outlet adaptor, and air outlet of water tank.
- Device Maintenance: No regular maintenance is required beyond cleaning and filter replacement. If abnormal running, abnormal sounds, device or power supply drops, or liquid has entered the device, disconnect power and contact supplier.
- Storage and Disposal: Store the device under prescribed ambient conditions. Dispose of the product in household waste. Consult an authorized, certified electronic waste recycling company for proper disposal. The device packaging can be disposed of as waste paper.
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