Nellcor N-395 - INTRODUCTION; Intended Use; General Operating Principles and Conditions

INTRODUCTION
intended Use
General Operating Principles and Conditions
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INTENDED USE
The N-395 is a portable pulse oximeter intended for use as a
continuous
non-invasive monitor of functional oxygen saturation
of arterial hemoglobin
(SpOz) and pulse rate. Tlze intended
patient population coinprises adult, pediatric, and neonatal
patients. The intended environments of use are hospitals,
hospital-type facilities, intra-hospital transport environments, and
home care. The N-395 is for prescription use only. Hospital use
typically covers such areas as general care floors, operating
rooms, special procedure areas, intensive and critical care areas,
within
the hospital plus hospital-type facilities such as
surgicenters, sub-acute centers, special nursing facilities, and
sleep labs, outside of the hospital. Intra-hospital
transport
includes transport of a patient within the hospital or hospital-type
facility.
WARPJING: The N-395 is intended only as an adjunct in
pakient assessmnt. It must be used in conjunction with
clinical signs and symptoms.
GENERAL OPERATING PRlNClPLES AND CONDInONS
The N-395 uses pulse oximetiy to measure functional oxygen
saturation in the blood. Pulse oximetry works by applying
a
sensor to a pulsating arteriolar vascular bed, such as a finger or
toe.
The sensor contains a dual light source and a photodetector.