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The Single Use 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 XactTrace belt
system and includes information on intended use, warnings and
cautions, system components, adjusting and attaching the belts, storage
and cleaning.
Intended Use
The Single Use XactTrace belt 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 Single Use XactTrace belt
system is intended for diagnostic purposes only and is not intended to be
used as an apnea monitor. Use the Single Use XactTrace belt system
only under the direction and supervision of a physician or trained
technologist.
Warnings and Cautions
The belts are intended to be worn over the patient's nightclothes.
The belts are single use.
Do not stretch the belts too tightly around the patient as this may
cause discomfort
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Summary of Contents for Embla XactTrace
- Page 1 The Single Use 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 XactTrace belt system and includes information on intended use, warnings and cautions, system components, adjusting and attaching the belts, storage and cleaning.
- Page 2 Single Use XactTrace™ Belt System User Instructions Caution must be taken to ensure that cables do not encircle the patient's neck. Special attention is needed in the case of children. Use the device only under the direction and supervision of a physician or trained technologist.
- Page 3 The belts are intended to be worn over nightclothes and should fit the patient snugly without being uncomfortably tight. Avoid all unnecessary contact with moisture when using the Single Use XactTrace belt system. Note: Do not use two thorax sensors or two abdomen sensors in the same recording.
- Page 4 Single Use XactTrace™ Belt System User Instructions Adjusting the Belt Size Adjust the belt by sliding the loop buckles on each end to maintain a snug fit around the patient circumference.
- Page 5 “yellow” connector. 3. Connect the abdominal (yellow) and the thoracic (blue) XactTrace connectors to the appropriate color-coded inputs on the recording device.
- Page 6 Cleaning No part of the Single Use XactTrace belt system requires sterilization. If desired, wipe the sensor and cables with a hospital grade cleaner that is not corrosive to plastic or metal, and then dry with a clean, dry cloth. Do not immerse the sensor in liquid and avoid contact of the cleaning solution with the connectors.
- Page 7 6 months from the date purchased. The sole liability of Embla and our distributors is limited to replacement or repair of the product at the option of Embla, with no charge for parts or labor if any part is proven to be defective in workmanship, performance, or materials during the warranty period.
- Page 8 Single Use XactTrace System User Instructions Copyright © 2017 Natus Medical Incorporated. All rights reserved. Printed in China. 013190, Rev. 05 All rights reserved. This manual contains proprietary information, which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Natus Neurology Incorporated.
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