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The Universal XactTrace 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 Universal XactTrace system and
includes information on intended use, warnings and cautions, system
components, adjusting and attaching the belts, battery status, storage, cleaning,
disposal, appropriate equipment to use with the system, and technical
specifications.
Intended Use
The Universal XactTrace system measures 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 the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep
clinics, or other test environments. The Universal XactTrace system is intended
for diagnostic purposes only and is not intended to be used as an apnea monitor.
Use the Universal XactTrace system only under the direction and supervision of
a physician or trained technologist.
