Precautions

After analysing the risks associated to the use of the device, we have identified some residual risks.

The following table summarizes the residual risks and the recomended course of action for each of them.

#	Situation	Recommended course of action
5	Incorrect clinical information: the care provider receives into their system data that is erroneous	The device must always be used under the supervision HCP, who should confirm or validate the output of the device considering the medical history of the patient, and other possible sympthoms they could be suffering, especially those that are not visible or have not been supplied to the device
6	Incorrect diagnosis or follow up: the medical device outputs a wrong result to the HCP	The device must always be used under the supervision HCP, who should confirm or validate the output of the device considering the medical history of the patient, and other possible sympthoms they could be suffering, especially those that are not visible or have not been supplied to the device. Also, we encourage you to review the metadata returned by the device about the output, such as explainability media and other metrics.
9	Image artefacts/resolution: the medical device receives an input that does not have sufficient quality in a way that affects its performance	The Instructions for Use contain extensive indication on how to take pictures in a section called How to take pictures. We also offer training to the users to improve the imaging process so that it is optimal for the device's operation; feel free to request such training to your closest sales representative. Also, we encourage you to pay attention to the information regarding image quality that the device outputs alognside the clinical information.
11	Data transmission failure from care provider's system: the care provider's system cannot connect to the device to send data	The Instructions for Use contain extensive indication on how to integrate the device into the care provider's system in a section called Installation manual.
12	Data input failure: the medical device cannot receive data from care providers	The Instructions for Use contain extensive indication on how to integrate the device into the care provider's system in a section called Installation manual.
13	Data accessibility failure: the care provider cannot receive data from the medical device	The Instructions for Use contain extensive indication on how to integrate the device into the care provider's system in a section called Installation manual.
14	Data transmission failure: the medical device cannot send data to care providers	The Instructions for Use contain extensive indication on how to integrate the device into the care provider's system in a section called Installation manual.
30	Inadequate lighting conditions during image capture: The medical device receives an input that does not have sufficient quality	This is similar to risk ID 9, but with a very simple solution: use the flash. If you can't use the flash and still the image is dark, move to a different environment with better lightning. Also, we encourage you to pay attention to the information regarding image quality that the device outputs alognside the clinical information.