T
titanius
Hello Everyone, i have a question.
We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.
With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?
Thank you for reading ! Any insights are most appreciated!
We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.
With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?
Thank you for reading ! Any insights are most appreciated!