User Manual PAP System(iBreeze CPAP System)
Contents 1 Welcome ...................................................................................................................... 1 2 Intended Use ................................................................................................................ 1 3 Contraindications .........................................................................................................1 4 Safety Information ..............................................................................................
12.5 Device Maintenance ..................................................................................... 29 13 Maintenance .............................................................................................................29 14 Storage and Disposal ............................................................................................... 30 14.1 Storage .......................................................................................................... 30 14.2 Disposal ............
iBreeze CPAP System User Manual 1 Welcome The iBreeze CPAP Systems contains CPAP and APAP Modes. They are both continuous positive airway pressure devices. The iBreeze CPAP Systems include the following models: iBreeze 20C, iBreeze 20C Pro, iBreeze 20A and iBreeze 20A Pro.
iBreeze CPAP 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.
iBreeze CPAP 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.
iBreeze CPAP 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.
iBreeze CPAP System User Manual 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 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.
iBreeze CPAP System User Manual 5 Symbol The following symbols may appear on the device, power supply and accessories. Symbol Definition Manufacturer. Date of Manufacture. Serial number. DC Power. Temperature limitations at transport and storage. Humidity limitations at transport and storage. Atmospheric pressure at transport and storage. Follow instruction for use. This label on the device points the user to the operator’s manual for complete information.
iBreeze CPAP System User Manual 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 at transport and storage. Keep away from sunlight. Stacking limitations. Recyclable materials.
iBreeze CPAP System User Manual 7 System Overview # Device Feature Description 1 Starts and stops the 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.
iBreeze CPAP System User Manual 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 pull 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. 3.
iBreeze CPAP System User Manual 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.
iBreeze CPAP 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. ❶The fill line indicates 1/3 water level for safe operation. ❷The fill line indicates 2/3 water level for safe operation. ❸The fill line indicates the maximum water level for safe operation. CAUTION: Use only room temperature distilled water or purified water.
iBreeze CPAP 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.
iBreeze CPAP System User Manual 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”.
iBreeze CPAP System User Manual # 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 Displays 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 Set humidifier level to enhance patient comfort of respiration.
iBreeze CPAP System User Manual Figure2 Patient Therapy Interface # 1 Description The current therapy mode. 2 Display the alarm messages. 3 Humidity adjustment shortcut key and humidity level. Note: The humidity level is available when the humidity function is on. 4 Background breathing dynamic diagram. 5 The current therapy pressure. 6 The therapy parameters monitoring during therapy. 7 Displays the oxygen saturation and pulse rate values when the oximeter adapter is connected.
iBreeze CPAP 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.
iBreeze CPAP 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 Set the Mask type. Option: Full Face / Nasal / Pillow Mask Type Default: 15 mm 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.
iBreeze CPAP 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.
iBreeze CPAP System User Manual Icon Text Description Set the Reminder type and time. You can turn on or off the different type of reminders, including: Mask, Filter, Water tank, Tube, Clinic, Maintenance interval. Option: ON / OFF Default: OFF Note: 1. Set the date of reminder, will pop-up reminder box first time to enter standby mode in the day of setting reminder day. Reminder 2. Click OK to change the relevant accessories, and then no longer remind. 3.
iBreeze CPAP System User Manual Item Description Period 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. Usage Number of hours the device has been used in the selected period. AHI The average apnea-hypopnea index in the selected period. Mask fit Use three stars for rating the leakage of mask in the selected period. The mask seal status is good. The mask needs adjustments.
iBreeze CPAP System User Manual 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 network，connect to the network through APP or connect to the network through the device.
iBreeze CPAP System User Manual 9.2.7.
iBreeze CPAP System User Manual 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. 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.
iBreeze CPAP System User Manual Alert Type Possible Cause Action Non-original card,continue using please format. Notification Insert other device' SD card in non-service mode. Format the SD card in your computer and then insert it to device. 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.
iBreeze CPAP System User Manual Alert Type Possible Cause Action threshold value. parameter setting. Check the respiration tube or adjust therapy parameter setting. Check the respiration tube or adjust therapy parameter setting. Check the connection of the mask or respiration tube, and the connection of the water tank. Low Respiratory Rate (RR). Alert 0 Apnea. Alert 1 High Leakage Volume. Alert 1 High Inspiration Pressure. Alert 0 Low Expiratory Pressure. Alert 0 Mask vent holes blocked.
iBreeze CPAP 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 There’s no power at the outlet or the device is unplugged. Check the outlet and verify that the device is properly plugged in. Make sure there is power available at the outlet.
iBreeze CPAP System User Manual Problem Possible Cause Action mask seems too low progress. Ramp Time off. I have stopped therapy, but the device is still blowing air. Device is cooling down. Device blows a small amount of air in order to avoid condensation in the air tubing. It will stop automatically after a few minutes. The device’s display is erratic (crash blank or blue screen). The device has been dropped or mishandled. Unplug the device. Reapply power to the device.
iBreeze CPAP System User Manual 12 Cleaning and Maintaining 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 Weekly Clean the device. Clean the tube. Clean the water tank. Monthly Clean the air filter. Every 6 months Replace the air filter. Annually Replace the tube.
iBreeze CPAP System User Manual 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.
iBreeze CPAP 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 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.
iBreeze CPAP System User Manual 15 Specification Physical Dimension (L*W*H): 238*178*128 mm Weight: Approximately 1.
iBreeze CPAP 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.
iBreeze CPAP System User Manual Model: SONOSAT-W01LT SpO2 Range: 0%~100% SpO2 Accuracy: 70%~100%: ±2%; Pulse Rate Range: 18~250 bpm Pulse Rate Accuracy: 18~250 bpm: ±3 bpm; Note: refer the user manual (version: 1.1) for more details. Model: iPOM, iPOM Lite SpO2 Range: 70%~100% SpO2 Accuracy: 80%~100%: ±2%; 70%~79%: ±3% Pulse Rate Range: 30~250 bpm Pulse Rate Accuracy: ±2 bpm or ±2%, whichever is greater Note: refer the user manual (version: A) for more details.
iBreeze CPAP 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.
iBreeze CPAP 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%.
iBreeze CPAP 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
iBreeze CPAP 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.
Contact information Manufacturer: Resvent Medical Technology Co., Ltd. Registration / Factory address: Room-602, Building B&C, Gaoxinqi Industrial Park, Liuxian No.1 Road, Xingdong Community, Bao'an, 518100 ShenZhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-0755-23027370 Fax: 0086-0755-23027370 http://www.resvent.com Issue date: May.,2022 © Resvent Medical Technology Co., Ltd. All rights reserved H-40101-010010-00 V2.
Quick Operation Guide 2 1 Open the lid, fill pour water to the Remove the humidifier chamber. maximum mark. 4 3 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.
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. 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.
