(196 days)
The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.
The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.
The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dolphin ONE Pulse Oximetry Forehead Sensor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy (ARMS) |
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).