Clinical Measurement Accuracy With Hitachi Diagnostic Ultrasound System - Olympus BF-UC180F Instructions Manual

Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: "Information for Manufacturers
Clinical measurement accuracy with Hitachi diagnostic
ultrasound system
162
 Acoustic measurement uncertainty
Quantity
W
PII
Pr
Fc
 When combined with SSD-5
Measurement feature
Distance in B-mode
Area by trace in B-mode
Circumference by trace
B-mode
Area by ellipses in B-mode
Volume in B-mode
Excrusion in M-mode
Time interval in M-mode
Velocity in Doppler mode
Heart rate
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Uncertainty (95% confidence)
General
accuracy
0.01 cm
3%
0.1 cm
0.01 cm
6%
0.1 cm
0.01 cm
6%
0.1 cm
0.01 cm
5%
0.1 cm
7%
0.01 cm
0.01 cm
3%
0.1 cm
1 ms
3%
0.1 s
10% 0.1 cm/sec
1BPM or 5% 1 beat per minute
8.07%
12.87%
7.63%
2.39%
Round-off accuracy
<10 cm distance
>10 cm distance
2 2
<100 cm area
2 2
>100 cm area
<10 cm distance
>10 cm distance
2 2
<100 cm area
2 2
>100 cm area
3 3
<100 cm area
<10 cm distance
>10 cm distance
<1000 ms time
>1000 ms time