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The DYMEDIX Incorporated Reusable Airflow/Snore Scnsor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breath sounds (snore). The sensors are used with patients who require a sleep study.

During evaluation of sleep disorders and other clinical applications for airflow recording, an airflow sensor is applied to the patient, typically under the nasal passages, to support recording of airflow signals. During the evaluation of sleep disorders and other clinical applications for breath sounds (snore) recording, a snore sensor is applied to the patient to support recording of snore signals. These recorded signals are analyzed by a qualified physician, clinician or licensed medical practitioner in support of diagnosis of sleep and airflow disorders. The Reusable Airflow/Snore Sensor is a pyroelectricity (pyro) and piezoelectric (piezo) sensor. The temperature difference between patient exhaled air and ambient air generates a small voltage signal, which can be recorded as airflow by diagnostic recording equipment. The vibration from breath sounds (snoring) produce a small voltage signal, which can be recorded as snoring by diagnostic recording equipment. The user's recording device displays the resulting signal for interpretation by a trained physician or clinician. Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing matcrial. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature. The predicate Disposable Airflow/Snore Sensor (K990321) applied the same PVDF Film airflow and breath sound (snore) sensing technology. The DYMEDIX Airflow/Snore Sensor consists of a temperature sensitive material (PVDF) molded into a reusable housing. The molding material is PVC. This same PVC material is used in the lead wires from the sensor. This same PVC material is used with the predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires, reference K990321.

The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software. The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt. The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded. The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded. The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.

The DYmedix Inc. Chin Electrode is a cutaneous electromyography (EMG) electrode. The Chin Electrode supports EMG monitoring of muscles in the chin and other surface EMG monitoring locations as directed by a physician during sleep studies.

The Chin Electrode is provided as a convenience to the sleep clinician. The Chin Electrode consists of three cutaneous electrodes within one assembly. In clinical application, the Chin Electrode is placed on the subject's chin. The lead wires are connected to the user's sleep recording instrumentation. The user's sleep recording instrument provides the electrical isolation for patient safety.