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The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use is attended use by trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.

The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels, up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor. The V series indicates the products are all made from the same parts with the only differences being that certain parts are not installed when assembled during manufacturing or some features are not enabled. The VasoGuard family consists of five different configurations of the same device, each varying in the number of pressure channels and sensor ports accessible through one of two available enclosures. The Full-Size enclosure supports Models V6, V8 and V10, and the Mini enclosure supports Models V2 and V4. All VasoGuard models contain the same main printed circuit board (PCB), manifold PCB(s), built-in power supply, built-in USB hub, and connect to a dedicated Windows-based medical grade PC via USB. Internally the models all utilize the same manifold assemblies and only differ in the quantity installed. The models include physical connections for control of 10 BP cuffs simultaneously, up to five PPG sensors simultaneously, one of up to three Doppler probes (4 MHz or 8 MHz), one USB camera, one IR remote control, and one touch-free infrared skin thermometer. The VasoGuard software is pre-installed on the Windows PC. It controls all the models and automatically recognizes which model is connected thereby exposing only software capabilities only available on that model. Each model includes certain components and accessories in addition to the VasoGuard device, including: - Medical Grade Touchscreen PC - Windows® 10 Enterprise LTSC - Washable Keyboard with Trackpad - Mobile Cart with Height-adjustable Rolling Cart - Set of Pneumatic Hoses with Articulating Support Arm - Set of Blood Pressure Cuffs (Shenzhen Vistar Medical Supplies Co., Ltd. K152468) - Set of PPG Sensors - Doppler Probes (4 MHz and/or 8 MHz) - USB Camera - Infrared Remote Control and Receiver - Touch-free Infrared Skin Thermometer (Tecnimed SRL - 510(k) K122412) The VasoGuard software features include patient database management; patient and exam search; importing and exporting of exams; facility management; importing of settings; exam protocol management, custom segment and vessel naming; customizable testing screens, reports, and graphs; backup and restore database; and keyboard shortcuts. The quantitative measurements are the same for all VasoGuard models. One of the primary measurements is the Ankle Brachial Index (ABI). The ABI uses the Doppler probe to determine the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. Another primary measurement of the VasoGuard is segmental blood pressures. Another main measurement of the VasoGuard is recording a waveform representing blood flow for each heartbeat. The system is capable of recording Doppler, PPG (photoplethysmography) and PVR (Pulse Volume Recording) waveforms.