(571 days)
Physiological purpose. An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of desaturation due to abnormal pulmonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.
As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Patient Care Information System (PCIS), a Spacelabs Medical Disposable SpO2 sensor provides the means to noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring of pulse saturation signals.
The SpO2 sensor converts optical signals into electrical signals from common monitoring sites. The acquired signals are transferred via an adapter cable to a pulse oximeter monitor for subsequent display, review, and editing by the care provider.
Sensors are available for specific monitoring sites, including the fingertip and foot, and are sized to meet various adult, pediatric and infant patient needs.
I'm sorry, but relevant information is not found in the provided text to generate a response. The document mostly focuses on the regulatory aspects of the device, such as its classification, predicate devices, and FDA approval, rather than detailed performance study data.
§ 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).