The iBreeze™ Resvent CPAP Machine

This product is on backorder with no eta.

Get a comfortable night of sleep with the iBreeze Resvent CPAP Machine. The iBreeze CPAP’s unique IPR (Intelligence Pressure Release) algorithm delivers personalized, comfortable ventilation therapy while you sleep. This machine also helps you avoid discomfort caused by dry air, thanks to an intelligent humidifier that maintains constant humidity and continuously monitors the water level.

The iBreeze CPAP system delivery 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 or hospital/institutional environment.

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 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.

Note: In either case above, it can only be determined by a competent physician whether to use CPAP device.

Specifications

• 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: ≤ 28 dBA (uncertainty of 2 dBA).
  • A-weighted sound power level: ≤ 36 dBA (uncertainty of 2 dBA).
• Standards compliance
  • IEC 60601-1:2005Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
  • IEC 60601-1-2:2014Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests.
  • ISO 80601-2-70:2015 Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of Sleep apnea breathing therapy equipment.
  • ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems.
  • IEC 60601-1-11:2015 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
  • AC Power Input: 100~240 V～ 50/60 Hz  2.0 A Max
  • DC Power Input: 24 V, ≤2.5 A
• 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
  • Pressure Control Accuracy: ±0.5 cmH₂O
  • Dynamic Pressure Variation: < 1 cmH₂O
  • Pressure monitoring Accuracy: ± (2%*full scale reading + 4%*actual reading)
• Flow
  • Flow: >120 L/min
• Humidifier
  • Water capacity: 290 ml (MAX Water Level)
  • Humidity: >10 mg/L BTPS (Within the set pressure range)

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.

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, Inc. 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, Inc.will repair or replace – at its option – the defective material or part. Resvent, Inc. will pay customary freight charges from Resvent, Inc. 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, Inc.