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We produce both our own as well as third-party developments based on the latest technologies. From the smallest batch series to large lot sizes we manufacture medical components and products, flow measurement systems and private labelings.

Our formula to success: many of our long-term manufacturing projects are the result of successful development partnerships.

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External Centrifugal Pump

Product: RotaFlow Drive RFD
External centrifugal pump for a heart-lung machine

Starting Point

Due to our in-house development of a heart-lung machine (HLM), em-tec has accumulated an extensive know-how in the field of all components of mechanical circulatory support systems. A customer was looking for a manufacturer of external drive components (centrifugal pump) that starts at the single-use tubing system and ensures the blood flow. With the help of several interfaces, the pump system can be attached to the control unit of the heart-lung machine.

Implementation

On the basis of detailed manufacturing instructions, em-tec was commissioned for the manufacturing, testing and certification of this HLM component. At this stage, the challenge this poses is to provide an unchanged functionality and quality of the product component based on the product development that, at this stage, took place more than 20 years ago. Since the further development of the existing HLM is not intended anymore, the functionality of the RotaFlow Drive RFD pump with the initial system as well as the awarded certification need to be ensured. In addition, there are complex adjustment and calibration processes that need to be carried out. Partial components of the centrifugal pump that are no longer available need to be substituted with equivalent parts without questioning the approval of the complete system or its functionality. Furthermore, the full traceability of all used product components must be guaranteed so that, in case of errors, all affected devices can be quickly and reliably identified.

Result

With the RotaFlow Drive RFD, the customer has been receiving a partial product for a heart-lung machine for more than 20 years. The product fits seamlessly into the complete system and is, even with components that are, from today's view, no longer up-to date, utterly reliable. Currently, we manufacture, adjust and, following extensive documentation, deliver about 300 RotaFlow Drive RFD systems per year. Due to the continuous quality assurance in close coordination with our quality management and the development department, the adherence to relevant standards is guaranteed at all times.

Customer
Maquet

Contract Manufacturing
External centrifugal pump for a heart-lung machine

Implementation Period
> 20 years

Components

OEM-Components: Sensors and Measurement Boards
For the control and measurement during the running of heart-lung machines

Starting Point

As a result of many in-house as well as contract developments, em-tec has been able to build a portfolio consisting of sensors and measurement boards, which have been continuously worked on and improved over three generations now. The components are mainly used in control units and the flow measurement in heart-lung machines. Based on the ultrasonic transit time method, it is possible to realize various ultrasonic flow measurement systems that can then be used to control heart-lung machines or other medical devices.

Implementation

em-tec enables various different customer-specific calibrations and adjustments to sensors and measurement boards so that they can be integrated into all kinds of devices. Especially the full compatibility to existing interfaces, bus connections and transmission reports is ensured through the close cooperation with em-tec's development department. Next to the technical integration of the measurement board, this also concerns the manufacturing of sensors which can be adjusted to different fields of application through the use of specific tools.

Result

Every adjustment of em-tec's OEM product range of sensors and measurement boards is done in accordance with the relevant standards ISO 13485 and ISO 60601. When it comes to software, it is the norm IEC 62304 that serves as guideline. MDR ist planned. This ensures that components can usually be faultlessly and safely integrated into existing systems without any additional certification processes. After the successful adjustment, em-tec also takes care of the serial manufacturing of the requested configuration. All these processes are accompanied by a comprehensive quality assurance in close coordination with our quality management and the development department. This ensures that all relevant standards are adhered to at all times.

Customer
Various Customers

Contract Manufacturing
Sensors based on the ultrasonic transit time method as well as suitable measurement boards

Implementation Period
Individual adjustment within a few weeks

Air Bubble Sensor

Product: Air Bubble Sensor ABS
Air Bubble Detection in an External Circuit

Starting Point

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 are detected, 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.

Result

The air bubble sensor is manufactured exclusively for a manufacturer of heart-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.

Customer
Maquet

Contract Manufacturing
Bubble detection device based on ultrasound

Implementation Period
> 20 years