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Miniaturized Modules for different Biosignals by using enhanced integrated digital circuits

Objective

MCC is developing and manufacturing small portable units for monitoring vital biosignals or screening and diagnosing possible deseases at home. These products are available as finished units and also as OEM product. The OEM products are PCB modules which the customer integrates in his own devices. The action consists of the improvement of a special OEM module which measures online and non-invasively the oxygen saturation at the finger tip. The digital CPU part of the electonic board will be miniaturized with FPGA technology. An enhanced functionality of the board can be achieved caused by the miniaturisation like multisignal measurement, implementation of multiple interfaces to link the board to different types of hosts, integration of telemetry interface (eg. Modem) to offer possibilities of telemonitoring by keeping the same size of the board. In this project the OEM module will be improved as a representative also for other products where the new technology can be integrated.

Objectives:
The main objective is the development of a new digital CPU module with integrated new FPGA technology which will be integrated in an improved pulse oximeter PCB module . The digital CPU part of this module consists of this new technology which will also be integrated in other modules and products. Thus synergy effects are reached by carrying out this technology project. For the implementation of this action all specifications of the product and project management activities have to be described. Special training for acquiring knowledge about FPGA design and its hardware programming is another objective to start with the actual development work. The prototype has to be evaluated technically and clinically for the following qualifcation and CE conformity. As outlook the integration of the technology in other products must be defined.

Work description:
All projects and its development processes are well described and specified in our QA handbook eg.all necessary workpackages, the planned project time, milestones, personal ressources ect. Further all activities according to the EN standartizations and the Medical Device Directive (MDD) have to be defined.The training course (on the project) includes: microelectronic, project management, specification, use of hardware description language (ABEL-HDL), simulation and testing. Further special training on the design of FPGA's have to be done.The development of the hardware design and software for the FPGA includes the following steps: part list, schematics, a first layout sample and laboratory tests of the FPGA software. For integrating the FPGA in our electronical design of the pulse oximeter, the software structure for configuration of the FPGA has to be designed. Test programms must be written for testing the circuit. With improved samples the application software of the current pulse oximeter must be implemented on the new hardware. The design of the PCB must be constructed with the help of the CAD system.Technical and clinical evaluation with several tests will follow. During this phase changes at the present FPGA software or at the PCB layout could be possible and restoring work has to be done. As outlook the integration of the improved technology in other products will be specified and all actions have to be documentated in a FUSE report.

Milestones:
1. A project plan and specification book for the complete improved product will be defined.
2. Training on the new technology on the project and in different courses has to be attended to get knowledge about the new FPGA design.
3. A prototype of the improved products will be developed with all its evaluations, tests and qualification procedures.
4. All is documented in a final report.

Call for proposal

Data not available

Coordinator

MCC MEASURE CHECK AND CONTROL - GESELLSCHAFT FUER DIAGNOSESYSTEME IN MEDIZIN U. TECHNIK MBH & CO. KG
Address
Suedendstrasse 42
76135 Karlsruhe
Germany