Operator’s Manual
Operating Procedure
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The software package needed for the correct performance of the instrument comes installed in the PC, ready to be
used.
The application has been developed by applying the EN 62304:2007 standard. This standard establishes a classification
of the software on the basis of its critical nature and potential impact on the patient's health / clinical status.
The class for the overall system software is:
- Class B: non-serious injury is possible
The instrument includes a CPU board which allows the autonomous completion of a run once it has been launched.
This CPU board includes a STM32f4 processor with 8mb SD-RAM, 1mb flash, 1kb EEPROM, micro-SD card for internal
file storage with 8GB (HC1) type 10.
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