(440 days)
Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:
- Pulse rate
- Respiration rate
- Movement
The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.
The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring.
The system is comprised of the following components:
- Wearable device with multiple sensors
- Secure cloud environment with an API .
- Charger with accessories .
- Armband .
The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver.
Here's a breakdown of the acceptance criteria and study information for the Everion+ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Objective) | Reported Device Performance (Result) |
|---|---|---|
| Pulse Rate (PR) | RMSE ≤ 3 bpm | RMSE ≤ 3 bpm (met) |
| Respiration Rate (RR) | RMSE |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).