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(250 days)
Masimo Acoustic Respiration Sensors, infant and neonate
The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.
The subject device, the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo, is a noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest for the purpose of noninvasive respiration/respiratory rate monitoring in infant and neonatal patients (
Here's a breakdown of the acceptance criteria and study details for the Masimo Acoustic Respiration Sensors, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (Arms) |
|---|---|---|
| Respiration Rate Measurement Range | 4-120 breaths per minute | 4-120 breaths per minute (Implied by testing) |
| Respiration Rate Measurement Accuracy | ± 1 breaths per minute, over the entire range | 1.1 breaths per minute (when compared to manual/auditory reference) |
| Body Weight | Infant, Neonate |
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