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A medical laser device with a fiber delivery accessory (called hand piece A) passed Lab testing to comply with relevant IEC standards such as IEC 60601-1, IEC 60601-2-22, IEC 60825-1 last year. The laser has a touch screen display showing the output power setting. If the power setting is 10W then the output power measured from the hand piece A should be within 10W+/-20%.
If we design another fiber delivery accessory (called hand piece B) whose optic transition rate is 30% less than the hand piece A. So if we provide both hand piece A and B to customers, either one of them can meet the deviation critera (+/-20%). To prevent this problem, can we put a sticker on the hand piece B or addressed in the user manual clearly that the hand piece B transition rate is 30% lower than the hand piece A to let the customer know the real output measured from the hand piece B should be 7W if the power setting on the touch screen display is 10W.
In other words, if customer uses hand piece A, then the real output power should be 10W(shown on display) +/-20%. If customer uses hand piece B, then the real output power should be [10W(shown on display)*70%] +/-20%.
My question is
Can the same laser device with hand piece B still meet the IEC standard regarding output power should be within +/-20% of the laser settings? We want to use both hand piece A and B with the same laser device.
If we design another fiber delivery accessory (called hand piece B) whose optic transition rate is 30% less than the hand piece A. So if we provide both hand piece A and B to customers, either one of them can meet the deviation critera (+/-20%). To prevent this problem, can we put a sticker on the hand piece B or addressed in the user manual clearly that the hand piece B transition rate is 30% lower than the hand piece A to let the customer know the real output measured from the hand piece B should be 7W if the power setting on the touch screen display is 10W.
In other words, if customer uses hand piece A, then the real output power should be 10W(shown on display) +/-20%. If customer uses hand piece B, then the real output power should be [10W(shown on display)*70%] +/-20%.
My question is
Can the same laser device with hand piece B still meet the IEC standard regarding output power should be within +/-20% of the laser settings? We want to use both hand piece A and B with the same laser device.