(25 days)
The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.
Here's a summary of the acceptance criteria and study details for the Dolphin 2000™ Pulse Oximetry Y Sensor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Accuracy) |
|---|---|---|
| SpO2 Accuracy (Adults, Pediatrics, Infants) | Less than 2.0% ARMs (Absolute Root Mean Square difference) |
§ 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).