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For adult use. The Gereonics Ultra-Piezo Limb Movement Sensor (LMS) is used to detect periodic limb movements for recording or monitoring on a physiological amplifier. The LMS is intended for use in sleep disorders studies.

The Pro-Tech predicate device and the Gereonics Ultra-Piezo Limb Movement Sensor (LMS) utilize a piezo disc (sometimes referred to as a piezo element, diaphragm or bender). There is no external voltage supply -- the sensor directly converts motion to voltage. The piezo disc and output resistor convert minute taps to voltage. A lengthy lead wire extends from this assembly and terminates with two electrode style safety connectors. The LMS is applied to the patients limb using 3M Coban LF Latex Free Self-Adherent Wrap. The sensor is reusable and the self-adherent wrap is disposable. The predicate device is applied using a reusable Velcro strap with a pouch that holds the LMS.

The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.

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The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.

The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in Sleep Disorders Testing for the measurement of respiratory effort and frequency. It is designed for use with a bioamplifier attached to a physiological recording system. The Respiratory Effort Strap Sensor utilizes a processed polyvinylidene fluoride plastic film sensor as the detector for breathing motion. The small breathing deflection of the human body, typically measured on the stomach (abdomen) or chest (thorax), creates a small voltage in the piezoelectric plastic film sensor. There is no external voltage supply -- the sensor stressed by inhalation and exhalation directly converts motion to voltage. A passive low pass electronic filter is connected directly to the sensor and filters out frequencies above 15 Hertz to minimize noise and allow breathing frequencies to be monitored. The output from the passive filter, typically +/- 200 to 300 microvolts at 0.1 Hz, is connected to a bioamplifier in the physiological recording system where the signal is amplified for monitoring or recording. The sensor is secured to the body using a one inch wide strap system of Velcro hook and elastic loop material.