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The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous). The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications. The BASIC is not intended for home use. The BASIC is not intended for use on non-intact skin or eyes. Photo-plethysmography module. Pneumo-plethysmography module. The pneumo-plethysmography module measures volume changes in limbs or digits. Relative limb volume increases with each heartbeat. The pneumo-plethysmography module measures this increase and depicts it as a waveform. The pneumo-plethysmography is also used in conjunction with the Doppler module or the photo-plethysmography module to measure the systolic blood pressure in limbs or digits. In this case, the pneumo-plethysmography module is used to inflate a cuff to perform the occlusion. The photo-plethysmography module: the amount of blood in the skin changes with each contraction of the heart. The Photo-plethysmography module measures this change and depicts it in a waveform. The photo-plethysmography module is also used in conjunction with the pneumo-plethysmography module (blood pressure cuffs) to measure the systolic blood pressure. The photo-plethysmography module detects the return of the blood after the occlusion. The pneumo-plethysmography module is not intended for neonatal applications. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular

The diagnosis with the BASIC is performed via four separate modalities, each of which can be used to test either the arterial or venous system. These four modalities are: - 4 and 8 MHz continuous wave Doppler. - Photoplethysmography, - Air plethysmography, - Systolic pressure examination. The BASIC's principle of operation is based on: - Doppler mode: the real time ultrasound measurement of blood velocity in the examined vessel is displayed as a waveform. The time overation of the velocity is made with a 4 or 8 MHz probe. - Photoplethysmography: The photo plethysmography probe is placed on a digit or taped to the skin surface. The photo plethysmography probe contains an infrared light source and a sensitive photocell. The light source directs infrared light into the skin. The receiving photocell measures in real time the change of the amount of blood in the skin caused by the contraction of the heart. It depicts it in a waveform. - Air plethysmography: the real time measure of the change of blood volume in a limb. An Air-filled pressure cuff is used to measure these changes. By wrapping a pressure cuff on a patient's leg, arm or digit, the blood flow at these locations can be quickly assessed. Relative limb volume increases with each heart beat. Air plethysmography measures this increase and depict it in a waveform. - Systolic pressure examination requires a Doppler probe or an arterial photo-sensor and a pressure cuff to measure the patient's systolic pressure at different locations (legs, arms, digits). The important data are not the absolute value of the pressures but the pressure differences or ratio. The BASIC consists of the following components: - The main console, - The 4 and 8 MHz probes, - The photo-plethysmography sensors, - The cuffs (the cuffs are accessories not manufactured by Atys). The main consoles provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the BASIC. It contains a LCD screen and a thermal printer to display the parameters and charts associated with the tests. The console also houses the electrical and electronical components, the cuff inflate pump, the pressure sensor (that measures the pressure in the cuff). The device operates from 220 V supply. The 4 and 8 MHz probes are comprised of a sensor tip, a mechanical head, a cable and either two piezo electric transducers. The transducer transforms the electrical energy into acoustical energy and vice versa. The photo sensors are non focused sensors with two (arterial sensors) or four (vein sensors) emitters and a center receiver.