Visual inspection: during the investigation, deposits on the device were determined.Permeability test: a permeability test has shown that all components are permeable.During the permeability test bloody liquid were flushed out.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant 2.0 does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be determined.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can detect visible deposits in the progav 2.0; these did not affect the technical properties of the progav 2.0 at the time of the investigation.Based on our investigation results, we can detect an accelerated outflow at the shuntassistans 2.0.The deposits visible in the valve may have led to the change in the flow rate.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
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