DEVICE: INTEGRA (00863499000315)

Device Description: INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.