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Hakim Prog Cylindrical Valve System

Description The CODMAN^® HAKIM^® Programmable Valve includes a valve mechanism (Figures 1 & 2) that incorporates a flat 316L stainless steel spring in which the calibration is accomplished by a combination between a pillar and a micro-adjustable telescoping fulcrum. The valve chassis is made of titanium. The ball and cone are manufactured from synthetic ruby. Intraventricular pressure is maintained at a constant level by the ball and cone valve seat design. The pressure setting of the spring in the inlet valve unit is noninvasively adjusted by the use of an external programmer, which activates the stepper motor within the valve housing. The programmer transmits a codified magnetic signal to the motor allowing eighteen pressure settings, ranging from 30 mm to 200 mm H2O (294 to 1960 Pa) in 10 mm (98 Pa) increments. These are operating pressures of the valve unit and have been determined with a flow rate of 15–25 mL H2O per hour. The valve is classified by its working pressure with a specified flow rate and not by the opening and closing pressures. The pressure that a valve sustains with a given flow is the parameter that reflects the working pressure of the valve once it is implanted. Before shipment, each valve is calibrated with special equipment. Duplication of these test procedures cannot be accomplished in the operating room. The valve is marked with an x-ray detectable direction-of-flow indicator.

Medical Device Classification: III