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The Heart Rate Variability (HRV) Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers: - Expiratory pressure recording and display - Respiratory effort - Breathing cue metronome - Heart rate via electrocardiography (ECG) - Non-invasive beat-to-beat blood pressure from optional external device The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists. The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients.

The HRV Acquire (HRV) Device with TestWorks software can be used as a standalone cardiovagal device to support heart rate variability testing and expiratory pressure evaluation during valsalva breathing testing. The HRV device supports measurement of heart rate variability, respiratory effort from commercially available circumferential chest bellows, display of a valsalva breathing metronome breathing cue and display of non-invasive beat to beat blood pressure from an external device. An example of an external blood pressure device is the commercially available FMS Finometer, cleared to market by 510(k) K880572. Other commercially available, FDA cleared to market external beat to beat blood pressure devices with an analog blood pressure signal output may be applied. The HRV device user interface is integrated into the existing WR Medical Electronics CO TestWorks software. The Test Works software was cleared to market with the Q-Sweat device, 510(K) K992874. The Test Works software is modified to support an interface to the HRV device. The HRV device may be mounted to a standard IV Pole. The HRV device has two modes of operation: - 1) Valsalva Mode supporting valsalva breathing cue to the subject under test, - 2) Heart Rate Deep Breathing (HRDB) Mode. In both modes, the HRV device acquires and the TestWorks software displays heart rate and blood pressure. The HRV device eliminates the need for a separate ECG acquisition device when these types of studies are performed. The HRV device acquires a Lead II ECG signal. The HRV device and TestWorks software do not supply any alarms. All interpretation of acquired and displayed data is the responsibility of the physician/clinician supervising the test.

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future. Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode.

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures.

The O-Sweat device is measurement-only device which is designed to measure the rate & volume of sweating by capturing a sample of sweat (water) inside a small measuring chamber which is affixed to the skin. It does not measure any other parameters of the sweat sample. The measurement made is simply a calculation of moisture given off by the skin.