H900 humidifier for ventilators

Symbolbild: Engineering/ F&E kritischer Systeme für funktionale Sicherheit (Safety) und Cybersicherheit (Security) Efficient Update of Medical Software in Humidifiers for Ventilators

Hamilton Medical sells the HAMILTON H900 humidifier as an accessory to their ventilators. It is used for controlled humidification of the respiratory air of the ventilated patients. In the field, software updates were only possible with mechanical access to the device.

In order to simplify such updates, the device was to be expanded to include the function of a software update without hardware access. For this purpose Solcept developed an additional secure bootloader for Hamilton Medical for updates via a serial interface. The development was subject to the standards for medical software development.

We created and documented the whole concept, design and test specifications and then developed the code according to MISRA and Hamilton Medical coding rules. After a static analysis, the code was integrated with the humidifier and subjected to intensive system testing. Additionally, we developed a new PC tool for the update.

Since the software must be correct, we developed design documentation, coded according to guidelines, performed requirements management, generated test plans etc. as per the processes of our customer, all including the required traceability.

Project Scope

Expertise and Technologies

The software was developed according to IEC 62304 respectively, using the customer's processes, so that the back transfer was as easy as possible. On the target system C was used, according to MISRA-C and Hamilton Medical coding guidelines. Static code analysis was performed with PRQA QA-C and Klocwork, unit tests with Cantata. On the PC, C++ and Qt were used for the update tool.

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