Olympus EVIS EXERA II - Clinical Measurement Accuracy with Hitachi or FUJIFILM Healthcare Diagnostic Ultrasound System; Clinical Measurement Accuracy When Combined with Olympus Universal Endoscopic Ultrasound Center EU-ME1

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Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Clinical measurement accuracy with Hitachi or
FUJIFILM Healthcare diagnostic ultrasound system
 When combined with SSD-α10
Clinical measurement accuracy when combined with
Olympus universal endoscopic ultrasound center
EU-ME1
Measurement feature General
accuracy
Round-off accuracy
Distance in B-mode
±3%
±0.01 cm
±0.1 cm
<10 cm distance
>10 cm distance
Area by trace in B-mode
±6%
±0.01 cm
2
±0.1 cm
2
<100 cm
2
area
>100 cm
2
area
Circumference by trace
B-mode
±6%
±0.01 cm
±0.1 cm
<10 cm distance
>10 cm distance
Area by ellipses in B-mode
±5%
±0.01 cm
2
±0.1 cm
2
<100 cm
2
area
>100 cm
2
area
Volume in B-mode
±7%
±0.01 cm
3
<100 cm
3
area
Excrusion in M-mode
±3%
±0.01 cm
±0.1 cm
<10 cm distance
>10 cm distance
Time interval in M-mode
±3%
±1ms
±0.1 s
<1000 ms time
>1000 ms time
Velocity in Doppler mode ±10% ±0.1 cm/sec
Heart rate ±1BPM or ±5% ±1 beat per minute
Measurement Feature Accuracy Maximum measurement range
Length ±5% 20 – 40 mm
Direction ±5% 20 mm
Circumference ±10% 20 – 40 mm
Area ±10% 20 – 40 mm