Technical Specifications
| Model | Mode | Operating Pressure Range | |
|---|---|---|---|
| Operating Pressure Range | BA825W | CPAP | 4-20cmH2O |
| BPAP-S, Auto BPAP-S | IPAP: 4-25cmH2O EPAP:4-25cmH2O |
||
| ST830W | CPAP | 4-20cmH2O | |
| BPAP-S, BPAP-ST. BPAP-T | IPAP: 4-30cmH2O EPAP:2-25cmH2O |
||
| Dimensions | 10"x6"x5" with humidifier chamber attached | ||
| Weight | 3.4lbs with humidifier chamber attached 2.45lbs without humidifier attached |
||
| Respiratory rate | For BPAP-ST mode: Ti: 0.1-4.0sec, Ti Max: 0.3-4.0 sec. For BPAP-T mode: Ti: 0.1-4.0 sec | ||
| Noise | 26 +- 3dB(A) in the operating pressure of 10 cmH2O | ||
| Water capacity | 280 +- 20ml | ||
| Inspiratory and expiratory pressure drop | At a flow rate of 60L/min, the humidifier pressure drop is 0.6+- 0.2cmH2O | ||
The device is indicated to provide non-invasive positive airway pressure to spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea (OSA), and BPAP-T mode and BPAP-ST mode can be used for respiratory insufficiency. This device is intended for hospital and home use. It is not intended for patients dependent on mechanical ventilation.
The SimplyAir has been authorized by the FDA under an EUA but has not been FDA cleared or approved. The SimplyAir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. U.S. federal law restricts this device to sale by or on the order of a physician.
