How does Millar perform the test for the catheter's natural frequency specification?
The IFU specifications for Millar Mikro-Tip catheters is a subset result of engineering verification to BP-22 testing requirements. The natural frequency of the catheter was obtained by viewing the dampened harmonic response from a pressure impulse/ step response square pressure wave. The catheter output was measured using a digital storage oscilloscope (DSO). The frequency was calculated per Ref AAMI BP22:2011 18.104.22.168- Frequency Response.