guilhermegf
Registered
Hi,
We trying to develop the test plan for our ME Equipment and encountered a dilemma with TR 60601-4-2 performance criteria. Our device has a bright light for treating people's skin and we have defined the device cannot turn this light on unintentionally as an essential performance. So, first, we were wondering that while being submitted to ESD tests, and the performance criteria determined by the TR 60601-4-2 has to be B (where the device should meet the performance criteria after the following tests without the intervention of the operator), in case of a restart, the device would have to be able to turn on the light again without the operator doing anything at the same point of treatment that it stopped when the ESD was applied. But we are now thinking that this might interfere with our essential performance (the device cannot turn this light on unintentionally) when recovering from the test "unexpectedly". Would it be considered an operator intervention if we perfectly recovered the device at the same point it stopped, but with a count down and a "safety" "continue button" on the screen that shall be pressed to turn the light on again? Making it an intentional turn on?
Does anyone think that a pass/fail criteria could be "The treatment can stop for a while and restart to the treatment screen at the same time and treatment conditions and show a count down before returning the treatment alongside a button so the operator can continue the treatment" or even "The treatment can stop for a while and restart to the treatment screen at the same time and treatment conditions and show a button so the operator can continue the treatment" instead of something like "The treatment can stop for a while and restart without operator’s intervention"? Or would this be treated like a C performance criteria instead?
We trying to develop the test plan for our ME Equipment and encountered a dilemma with TR 60601-4-2 performance criteria. Our device has a bright light for treating people's skin and we have defined the device cannot turn this light on unintentionally as an essential performance. So, first, we were wondering that while being submitted to ESD tests, and the performance criteria determined by the TR 60601-4-2 has to be B (where the device should meet the performance criteria after the following tests without the intervention of the operator), in case of a restart, the device would have to be able to turn on the light again without the operator doing anything at the same point of treatment that it stopped when the ESD was applied. But we are now thinking that this might interfere with our essential performance (the device cannot turn this light on unintentionally) when recovering from the test "unexpectedly". Would it be considered an operator intervention if we perfectly recovered the device at the same point it stopped, but with a count down and a "safety" "continue button" on the screen that shall be pressed to turn the light on again? Making it an intentional turn on?
Does anyone think that a pass/fail criteria could be "The treatment can stop for a while and restart to the treatment screen at the same time and treatment conditions and show a count down before returning the treatment alongside a button so the operator can continue the treatment" or even "The treatment can stop for a while and restart to the treatment screen at the same time and treatment conditions and show a button so the operator can continue the treatment" instead of something like "The treatment can stop for a while and restart without operator’s intervention"? Or would this be treated like a C performance criteria instead?
