Investigation visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has shown that the valve is permeable.Adjustment test this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test this is a fixed pressure valve.A braking force and brake function test is not applicable.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 valve is tested in the vertical position.The results show that the valve is not operating within the acceptable tolerance.Results first, we performed a visual inspection of the shunt assistant 2.0.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to be permeable.Then we carried out a computer controlled simulated flow test.The measured opening pressure was not within the accepted tolerance range for vertical position.The opening pressure was significantly lower than expected in vertical position, indicating a tendency towards over-drainage.Finally, we have dismantled the valve.Inside the valve we have found slightly build-up of substances (likely protein).Based on our investigation, we confirm that the valve is operating in an under-drainage state, likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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