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This content applies to Device version: 1.1.0.0

Maintenance and lifetime

Maintenance

Due to its software nature, there is no maintenance required.

Lifetime

The expected operational lifetime of the device is established at 5 years, which is subject to regular software updates and the lifecycle of the integrated components and platforms. The lifetime will be increase in equivalent spans as the design and development continues and maintenance and re-design activities are carried out.

This timeline accounts for the expected evolution of the underlying operating systems and tools, the progression of medical device technology, and the necessary update cycles to maintain security and operability.