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The Single Use Pre-Sized XactTrace belt system is used during sleep
studies to acquire and transfer data related to thoracic and abdominal
respiratory effort to a compatible sleep recorder.
This document describes how to use the Single Use Pre-Sized
XactTrace belt system and includes information on intended use,
warnings and cautions, system components, adjusting and attaching the
belts, storage and cleaning.
Intended Use
XactTrace is intended to measure respiratory effort to assist in the
diagnosis of sleep disorders or sleep related respiratory disorders. The
respiratory effort signals measured are processed to provide electrical
signals suitable for connection to the inputs of physiological recording
equipment. The intended environments are hospitals, institutions, sleep
centers, sleep clinics or other test environments. XactTrace is intended
for diagnostics purposes only and is not intended to be used as an
apnea monitor.