(302 days)
The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.
The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.
Acceptance Criteria and Device Performance for SoftAire Nasal CPAP System
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Requirement | Reported Device Performance |
|---|---|---|
| Adjustable Therapeutic Pressure Range | 4-18 cmH2O | ☑ (Verified to operate as designed and intended) |
| Adjustable Beginning Pressure Range | 4 and 18 cmH2O and below therapeutic range | ☑ (Verified to operate as designed and intended) |
| Pressure Accuracy | ± 10% to the nearest displayed digit (calibrated at 500ft elevation) | ☑ (Verified to operate as designed and intended) |
| Timer | 0, 5, 10, 15, 20 minutes, ± 2 minutes | ☑ (Verified to operate as designed and intended) |
| Input Voltage | 12 ± 10% VDC, 2A | ☑ (Verified to operate as designed and intended) |
| Noise Level |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).