Throughout the years we've been working on the in-house development of a heart lung machine (HLM), we have accumulated extensive know-how when it comes to the many components of mechanical circulatory support systems. In this case, an external customer was looking for a manufacturer of bubble detection devices which can recognize air bubbles in external blood circuits through non-invasive ultrasonic measurements.
Task and Implementation
As external device, the air bubble device is attached to a single-use tube and connected to the control unit of the heart lung machine. If air bubbles occur, the centrifugal pump of the external blood circuit is automatically turned off. During the manufacturing process, two ultrasound sensors are built into a clamp, collated and then cast. Once assembled, all necessary assessment processes as well as calibrations are conducted alongside the final test and final acceptance.
The air bubble sensor is manufactured exclusively for a manufacturer of hear lung machines. The initial system has been in use for more than 20 years now. The partial component fits seamlessly into the complete system. At this stage, there are annually about 100 air bubble sensors manufactured, calibrated and, after extensive documentation, delivered to the customer. Accompanying the manufacturing process is the constant quality assurance which happens in close coordination with our quality management and our development department. This procedure ensures that all requirements are adhered to at all times.
Bubble detection device based on ultrasound
> 20 years
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