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Presygen™/si-1 is indicated for use in hospital facilities, along with clinical assessment of signs and symptoms, by healthcare professionals for non-invasive and non-diagnostic measure of relative temporal variation in oxygen saturation (StO2) in superficial tissue. Presygen™/si-1 displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports tissue oxygenation measurements in selected tissue regions. Presygen™/si-1 is intended for adults only (22 and over).

Presygen™/si-1 is a standalone, non-contact tissue oxygen saturation oximeter based on multispectral optical imaging techniques. The mode of action is to transmit lights at four (4) known wavelengths through blood in superficial tissue and measure the tissue oxygen saturation (StO2), based on the amount of diffusely reflected light. The Presygen™/si-1 software provides user control of the device and access to stored data, through a Graphical User Interface (GUI). The software controls hardware elements of the device such as illuminators, sensors, display and Input/Output, and manages communication between these elements and between processors and memory. The software also performs calculations to derive Tissue Oxygen Saturation (StO2) from optical inputs and display this to the device user in a two-dimension (2D) spatial map. The Presygen™/si-1 device has been designed with the additional capability of compensating for melanin levels in the skin, since absorption of light by melanin affects the measurement of the oxygenated hemoglobin and deoxygenated hemoglobin through the skin. The device consists of the following: - Imaging head: Contains optics, lasers, and electronics to display the %StO2 . - . Base compartment: Includes the wheels, brakes mechanism, SMB (Smart Multi-Media Board), power switch, certified power supply, fans, filters and cabling - . Touchscreen monitor display: User interface, display of image, and patient data - Keyboard: Used to enter user or patient information into the device . - Accessory: The Presygen™/si-1 Sterilized Drape is a prepackaged single-use third party . drape that is used with Presygen™/si-1 to avoid contamination during the imaging process.