Smart MED iBreeze Series User Manual
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Smart MED iBreeze Series User Manual

Cpap
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iBreeze Series CPAP

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Summary of Contents for Smart MED iBreeze Series

  • Page 1 User Manual iBreeze Series CPAP...

  • Page 2: Table Of Contents

    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 ............................8 8 Navigating the Device Screens ......................12 9 Operation...............................

  • Page 3: Welcome

    iBreeze CPAP Systems User Manual 1 Welcome The iBreeze PAP Devices contain either CPAP or CPAP and APAP (variable pressure) Modes. These modes are both continuous positive airway pressure modes during the respiratory cycle devices. These devices carry a 2 year limited warranty from the date of purchase. The iBreeze CPAP Systems include the following models: iBreeze 20C, iBreeze 20C Pro, iBreeze 20A, iBreeze 20A Pro.

  • Page 4: Safety Information

    iBreeze CPAP Systems User Manual The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear. Note: In any case mentioned, it is important to consult a competent physician with regards to whether to use a CPAP device.
  • Page 5 iBreeze CPAP Systems User Manual  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.
  • Page 6 iBreeze CPAP Systems 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. ...
  • Page 7 iBreeze CPAP Systems User Manual  Do not block the gas INTAKE PORT, thereby interfering with therapy.  Please follow the local regulation when disposal the device  The proper placement and positioning of the MASK on the face is critical to the consistent operation of this equipment.

  • Page 8: Symbol

    iBreeze CPAP Systems 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.

  • Page 9: System Contents

    iBreeze CPAP Systems User Manual Therapy On/Off Button (Starts and stops the airflow for therapy). This way up at transport and storage. Fragile, handle with care. Keep dry at transport and storage. Stacking limitations. Recyclable materials. 6 System Contents Your CPAP system may include the following items: ...

  • Page 10: System Overview

    iBreeze CPAP Systems User Manual 7 System Overview Device Feature Description Therapy On/Off Key Starts and stops the airflow for therapy. Ramp Key Activate the ramp feature during therapy. LCD Display screen This is the User interface for the therapy device. Control Dial Turn the dial to scroll between options on the screen.
  • Page 11 iBreeze CPAP Systems User Manual  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 touch the metal surface of the heater when you pull out the water chamber.
  • Page 12 iBreeze CPAP Systems User Manual  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: ...
  • Page 13 iBreeze CPAP Systems User Manual 7.4 Water-filling Operation 1. Remove the water chamber from the device. 2. Open the water chamber lid, fill it with water up to the maximum fill line. 3. Lock the water chamber lid. 4. Install the water chamber on the device. ❶The fill line indicates 1/3 water level for safe operation.

  • Page 14: Navigating The Device Screens

    iBreeze CPAP Systems 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.

  • Page 15: Operation

    iBreeze CPAP Systems 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 using the last settings entered by the user. 9.1 Starting the Device 1.
  • Page 16 iBreeze CPAP Systems User Manual Feature Description Mode Display the current mode. Enabled features Depending on setup, certain enabled therapy features will display here. Time Display the current time. Patient Sleep Quality Displays the patient sleep quality report and the options Report for period of the report are: daily (recent 6 days) / 7 days / 14 days / 1 month / 3 months / 6 months / 1...
  • Page 17 iBreeze CPAP Systems 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.
  • Page 18 iBreeze CPAP Systems User Manual 9.2.3 Patient Comfort Setting Press key in the Patient Standby interface to enter Patient Comfort Setting Interface. 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 Preheat the maximum preheating time is 30 minutes.
  • Page 19 iBreeze CPAP Systems User Manual Icon Text Description Set IPR (Intelligence Pressure Release) level. Option: OFF / 1-3 Default: 2 Backs the pressure off to make it easier to exhale. Set the increase time from Ramp pressure to the setting Ramp Time therapy pressure.
  • Page 20 iBreeze CPAP Systems User Manual Icon Text Description Set the Energy Saving function on or off. When Energy Saving is on, the screen will be turned off Energy Saving 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.
  • Page 21 iBreeze CPAP Systems User Manual Icon Text Description Set the Mask type. Option: Full Face / Nasal / Pillow Default: Nasal Mask Type Display the device informaiton including system version, serial number, blower running time etc.. About 9.2.5 Patient Report Menu Press info key in Patient Standby Interface to enter Patient Report Interface.
  • Page 22 iBreeze CPAP Systems User Manual Item Description Humidify Use three stars for rating the usage time of humidifier in the selected period. Humidifier has been used more than 60% of the total therapy time. Humidifier has been used less than 5% of the total therapy time.

  • Page 23: Device Alert

    iBreeze CPAP Systems 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.
  • Page 24 iBreeze CPAP Systems User Manual Alert Type Possible Cause Action Software update underway, do not cut Notification Software update. No action. off the power! Water level is too During the heating Remove the water low, please add to process, the water chamber and add to Alert 0 the appropriate...
  • Page 25 iBreeze CPAP Systems User Manual Alert Type Possible Cause Action Check the Respiratory Rate High Respiratory respiration tube or Alert 0 exceed the setting Rate (RR). adjust therapy threshold value. parameter setting. Check the Low Respiratory respiration tube or Alert 0 None.

  • Page 26: Troubleshooting

    iBreeze CPAP Systems User Manual 11 Troubleshooting If your device has the following problems in the usage, please try the following measures. If it can’t be resolved, please contact the maintenance provider. Problem Possible Cause Action Check the outlet and verify that the device is properly plugged in.
  • Page 27 iBreeze CPAP Systems User Manual Problem Possible Cause Action 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.

  • Page 28: Cleaning And Maintaining

    iBreeze CPAP Systems 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. For the cleaning interval of the device and accessories, please refer the below table: Interval Action Weekly...
  • Page 29 iBreeze CPAP Systems User Manual 12.3 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.

  • Page 30: Maintenance

    iBreeze CPAP Systems User Manual 13 Maintenance Your iBreeze CPAP therapy device is designed to have give you a useful service life of 5 years. If the therapy device is used as intended in accordance with the instructions for use, it does not require any extra maintenance or calibration within this period. If the therapy device is used beyond this period, we recommend having it checked by an authorized dealer.

  • Page 31: Specification

    iBreeze CPAP Systems User Manual 15 Specification Physical Dimension (L*W*H): 235*148*125 mm Weight: Approximately 1.55 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 A-weighted sound pressure level: ≤...
  • Page 32 iBreeze CPAP Systems User Manual Air filter Air filter: Filter Efficiency: >75% (7 micron dust) Pressure Setting Range: 4-20 cmH Max Single Fault Steady Pressure: 40 cmH Pressure Control Accuracy: ± 0.5 cmH Dynamic Pressure Variation: < 1 cmH Pressure monitoring Accuracy: ± (2%*full scale reading + 4%*actual reading) Flow Flow: >120 L/min Humidifier...

  • Page 33: Emc Declaration

    iBreeze CPAP Systems User Manual 16 EMC Declaration Essential Performance： CPAP mode: working pressure 10 cmH2O. The CPAP system is intended for use in the specified electromagnetic environment listed in form B-1, B-2 and B-3. The customer or the user of CPAP system should assure that it is used in such an environment as described below.
  • Page 34 iBreeze CPAP Systems User Manual Form B-2 Guidance and Declaration - Electromagnetic Immunity Immunity test IEC60601test Compliance Electromagnetic level level environment - guidance Electrostatic Contact：± 8kV Contact：± 8 kV Floors should be discharge Air：± 15 kV Air：± 15V wood、concrete or （ESD）...
  • Page 35 iBreeze CPAP Systems User Manual Immunity test IEC60601test Compliance Electromagnetic level level environment - guidance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances: d=0.35√p d=1.2√p Radiated RF 80MHz to 10V/m, 80% Am 80MHz to 800MHz： d=1.2√p IEC61000-4-3 2700MHz 10V/m...
  • Page 36 iBreeze CPAP Systems User Manual Form B-3Recommended 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- 800MHz-2.5GHz d=1.2√p d=2.3√p 800MHz d=1.2√p 0.01...
  • Page 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 ad confidential information. This manual serves as a reference. The instruction in this manual are not intended to supersede the health care professional’s instructions regarding the use of the device.
  • Page 39 Contact information Manufacturer: Resvent Medical Technology Co., Ltd. Registration Address: Room A602, Issue date: Sept., 2017 Building 1, Gaoxinqi Industrial Park Phase II, Liuxian No.1 Road, Xin’an Street, Baoan District, Shenzhen 518100, P.R.China ©2016 Resvent Medical Technology Factory Address: Room 802, Building 2, Gaoxinqi Industrial Park phase II, Co., Ltd.

This manual is also suitable for:

Ibreeze 20cIbreeze 20c proIbreeze 20aIbreeze 20a pro

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