Hello All,
I have a class IIb cleared medical device.
I would like to introduce a similar device with same intended use, only with a newer power supply from the same manufacturer and same size.
For example, in current device, the power supply is rated 160W with 24VDC output.
The new power supply is 300W with 24VDC output.
I read in an article that this may be considered a s a significant change since it is a a "change in the source of energy used by the device".
Do you have any insights as of whether its correct, and if yes, what does it mean a change in the source of energy used by the device:
Is it the power feeding the power supply inside the device (the 240V AC source) or its any change related to the internal power supply itself, even though its output stays the same (24V)only its power capabilities increases? (from 160 W to 300W)
Appreciate your input
Udi
I have a class IIb cleared medical device.
I would like to introduce a similar device with same intended use, only with a newer power supply from the same manufacturer and same size.
For example, in current device, the power supply is rated 160W with 24VDC output.
The new power supply is 300W with 24VDC output.
I read in an article that this may be considered a s a significant change since it is a a "change in the source of energy used by the device".
Do you have any insights as of whether its correct, and if yes, what does it mean a change in the source of energy used by the device:
Is it the power feeding the power supply inside the device (the 240V AC source) or its any change related to the internal power supply itself, even though its output stays the same (24V)only its power capabilities increases? (from 160 W to 300W)
Appreciate your input
Udi