Control systems for neonatal applications

Client company
A leading European company in the design, production and supply of a wide range of medical devices for respiratory support contacted Dinamica Generale to create control system for neonatal applications.

Objectives
The client company contacted Dinamica Generale providing functional specifications and statutory and regulatory requirements for the design, development and production of the device. The customer has, however, retained responsibility for the certification and marketing of the product.

Requirements
The main specifications that General Dynamics had to consider in developing the product were:
  • Selection of the most suitable sensor to perform the measurement of each parameter to be controlled, i.e. temperature, pressure and oxygen saturation percentage. Each sensor was chosen based on whether it satisfied the functional, environmental and storage specifications, paying particular attention to the statutory and regulatory requirements typical of a critical application such as neonatal assisted breathing
  • Assessment and identification of the main electronic components (microprocessor, A/D converter and memory) based on the functional specifications and with particular attention to energy consumption. In fact, the device needed to be battery powered, saving a large amount of data in its internal memory.
Incubator features
The portable battery-powered electromedical device designed by Dinamica Generale was created to be inserted in the ventilation circuits in neonatal incubators in order to regularly record the following essential parameters:
  • oxygen concentration [%];
  • blood pressure [10-2 cm H2O];
  • temperature [°C].
The application also provides the ability to set the minimum and maximum thresholds for each parameter and the subsequent detection of alarm conditions as soon as at least one of the monitored parameters detected is inconsistent with the minimum threshold indicated. 
Once recorded in the device's internal memory, the data is transferred to a PC through an application that can acquire and integrate the information into the database. In doing so, the internal memory can be reset at the end of each transfer.

Adopted solutions
Dinamica Generale worked with the client to define the product specifications, subsequently developing the requested component and defining and implementing production lines for its assembly and testing in accordance with applicable specifications and directives.
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