Olympus EVIS EXERA II - Acoustic Output Table When Combined with Olympus Universal Endoscopic Ultrasound Center EU-ME1

Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
241
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
 Acoustic measurement uncertainty
Acoustic output table when combined with Olympus
universal endoscopic ultrasound center EU-ME1
 Acoustic output table
 Global maximum derated I
SPTA
and MI values when
combined with the EU-ME1
 Acoustic measurement precision and uncertainty
Quantity
Uncertainty
(95% confidence)
W
0
12.22%
PII 25.62%
Pr 13.19%
F
c
2.39%
I
SPTA.3
62
TI type TIS, TIB
TI value 0.83
MI 0.99
I
PA.3
@MI
max
377
Imaging mode Derated I
SPTA
MI
B mode 15 0.99
Color flow mode 46 0.97
Power flow mode 62 0.94
Quantity Uncertainty (%)
Pr 17
W
0
44
f
c
17
PII 41
MI 20
I
SPTA.3
48