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Hakim Prec BurrHole Valve System

The CODMAN^® HAKIM^® Precision Fixed Pressure 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 operating pressures of the valve unit have been determined with a flow rate of 10–25 ml H2O per hour. The valve is classified by its operating 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 operating 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. Several models of the valve have been marked with an x-ray detectable direction-of-flow indicator.

Medical Device Classification: III