ZuzaMed
CTG portable fetal monitor
CTG medical device designed to provide information about a fetal heart status
Challenge
Develop real-time embedded application for CTG portable monitoring of fetal heartbeat based on existing battery powered hardware. The device should gather signals like a cardiotocograph and process it for detecting fetal heartbeat disorders.
Develop real-time embedded application for CTG portable monitoring of fetal heartbeat based on existing battery powered hardware. The device should gather signals like a cardiotocograph and process it for detecting fetal heartbeat disorders.
Approach
The first thing to do was an audit of existing hardware and software. We decided to develop software from the beginning and we tested each part of the hardware step by step to be 100% sure that we can use it without changes. In parallel, we began to develop processing algorithms based on existing examples of signals in a higher abstraction layer and documentation in accordance with the IEC 62304 standard. After performing basic hardware tests, we have tested a few collections of settings for gathering signals from the maternal abdomen. We chose settings for recording data and then started to develop real-time versions of processing algorithms. Selected microcontroller did not have an FPU (Floating-Point Unit) but changing the heart of the device may have caused too much delay, so we decided to design algorithms based on fixed point number format to increase efficiency. At this stage, an additional debug file was added to our system with special data about recording and processing signals. The validation of real-time algorithms on the device was successful, so after agreeing with the client, we started working on improving the desktop application.
The first thing to do was an audit of existing hardware and software. We decided to develop software from the beginning and we tested each part of the hardware step by step to be 100% sure that we can use it without changes. In parallel, we began to develop processing algorithms based on existing examples of signals in a higher abstraction layer and documentation in accordance with the IEC 62304 standard. After performing basic hardware tests, we have tested a few collections of settings for gathering signals from the maternal abdomen. We chose settings for recording data and then started to develop real-time versions of processing algorithms. Selected microcontroller did not have an FPU (Floating-Point Unit) but changing the heart of the device may have caused too much delay, so we decided to design algorithms based on fixed point number format to increase efficiency. At this stage, an additional debug file was added to our system with special data about recording and processing signals. The validation of real-time algorithms on the device was successful, so after agreeing with the client, we started working on improving the desktop application.
Outcome
We developed embedded and desktop applications for the device and this CTG portable device is successfully commercialized. We also delivered all needed software documentation for the device certification based on the IEC 62304 standard. The device shows complete compliance of the received data with cardiotocography used in medical practice at over 90% level. To check on the wellbeing of the fetus within the mother's womb, the expectant mother may easily place the ZuzaMed gadget on her tummy. There is no time limit on how long it can be used for.
We developed embedded and desktop applications for the device and this CTG portable device is successfully commercialized. We also delivered all needed software documentation for the device certification based on the IEC 62304 standard. The device shows complete compliance of the received data with cardiotocography used in medical practice at over 90% level. To check on the wellbeing of the fetus within the mother's womb, the expectant mother may easily place the ZuzaMed gadget on her tummy. There is no time limit on how long it can be used for.
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