natus XactTrace User Instructions

natus XactTrace User Instructions

Single use pre-sized belt system
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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.
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Summary of Contents for natus XactTrace

  • Page 1 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.
  • Page 2: Warnings And Cautions

    Single Use Pre-Sized XactTrace™ Belt System User Instructions Warnings and Cautions  XactTrace shall be worn over the patient's clothing The belts are single use.  Do not stretch the belts too tightly around the patient as this may cause discomfort ...
  • Page 3: System Components

    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 Pre-Sized XactTrace belt system. Note: Do not use two thorax sensors or two abdomen sensors in the same recording.
  • Page 4 Single Use Pre-Sized XactTrace™ Belt System User Instructions Choosing a Belt Size The Single Use XactTrace belts come in four sizes: Large, Medium, Small and Pediatric. The length of the belt size can be adjusted to ensure a good fit. The belts should fit the patient snugly without being uncomfortably tight.
  • Page 5 Single Use Pre-Sized XactTrace™ Belt System User Instructions Attaching the Belts to the Patient 1. Encircle the belt around the patient chest and secure the snap ends of the belt to the buckle with the “blue” connector as shown in the figure below. The belt should fit snugly without being uncomfortably tight.
  • Page 6: User Settings

    Single Use Pre-Sized XactTrace™ Belt System User Instructions 4. External RIP processor modules are required only with non- Embla amplifiers, referred to as “universal” applications. When using the RIP processor modules, insert the connector from the Chest belt into the processor module labeled THORAX, and then insert the connector from the Abdomen belt into the processor module labeled ABD.
  • Page 7: Technical Specifications

    Single Use Pre-Sized XactTrace™ Belt System User Instructions Technical Specifications See the table below for technical specifications for the XactTrace Single Use Pre-Sized Respiratory Effort System. Physical Properties Pre-Sized lengths – Based on sizing Belt Length: chart found under Fitting the XactTrace Belts.
  • Page 8 0.2 to 3 Hz Sensitivity: Approximately 50µV/mm Storage Proper storage extends the life of the Single Use Pre-Sized XactTrace belt system. To prevent damage, do the following when storing the sensor and belts between studies.  The belts are single use and should not be used for more than one study.
  • Page 9: Maintenance

    This symbol indicates that the item should not be reused and is intended for a single-use only. Maintenance No special maintenance of the Single Use Pre-Sized XactTrace belt system is required. Warranty Embla warrants the sensor to be free of defects in materials and workmanship for 6 months from the date purchased.
  • Page 10 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. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information is preserved.

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