tBPC oCare Pro100 - Introduction and Device Overview; Intended Use and Introduction

Taiwan Biophotonic Corporation
21
1. Introduction
Intended Use
The tBPC’s oCare
TM
Wrist-worn Pulse Oximeter, Model Pro
100, is a wrist-worn device indicated for use in noninvasive
measuring, displaying, and storing functional oxygen saturation
of arterial hemoglobin (% SpO
2
) and pulse rate (PR). The
intended measuring site of this device is the wrist skin surface.
It is intended for spot-checking or continuous monitoring of
adult patients during no motion conditions, in hospitals,
hospital-type facilities, and home environments.