Introduction; Intended Use - Philips G5 solution Instructions For Use Manual

Introduction

Intended use

Philips wearable biosensor-G5 solution is a single-location, chest-
worn heart rate monitor. The wearable biosensor-G5 solution includes
a wearable biosensor-G5 and software application. The wearable
biosensor-G5 is a single-use device measuring heart rate by continuously
acquiring surface electrical waveforms related to cardiac excitations
and measuring beat-to-beat intervals when a patient is stationary or
ambulatory. The biosensor functions by capturing and then sending
physiological data wirelessly to the software application. The biosensor's
frequency of data collection and transmission is configurable.
The software application is a single-patient use device, intended as
an accessory to the biosensor to display and store physiological and
operational data. The software application receives and displays data
from the biosensor providing a user interface and exportable file for
retrospective review and analysis. The application allows configuring the
biosensor frequency of data collection and transmission.
Indications for use
The Philips wearable biosensor-G5 is indicated for single patient use
whenever heart rate measurement is needed in non-critical hospital
settings. The Philips wearable biosensor-G5 solution is used as a higher
resolution heart rate log by nurses or physicians retroactively as an aid
in making non-critical or non-life threatening therapeutic decisions. The
biosensor is intended for patients who are 18 years of age or older.
Note
Before using this product to obtain heart rate, carefully read the instructions
for use and the quick start guide on the G5 biosensor package.
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