Appendix A Technical Description
Instructions for Use A - 33
Measurement Range and Accuracy
The following tables describe the variability in accuracy for clinical measurements.
Clinical Measurements: Range and Accuracy
Direct
Tolerance
Tolerance Function or Value (Accuracy)
Distance* 0 – 36 cm Tol(D)
3% of the distance or 1.5 mm; whichever is
greater assuming 1,540 m/sec speed of sound.
Does not apply to trace tool. Distance tolerance
using trace tool is user-dependent.
Distance using
SieScape extended
field of view
0 – 60 cm Tol(D)
Linear transducer: 5% of the distance or 2.5 mm;
whichever is greater assuming 1,540 m/sec
speed of sound.
Curved transducer: 8% of the distance or
2.5 mm; whichever is greater assuming
1,540 m/sec speed of sound.
Trace Area* 0 – 560 cm
Tol(A)
6% of the area or 1.5 cm
; whichever is greater,
assuming minimal operator error in tracing the
desired object and assuming 1,540 m/sec speed
of sound.
Time @
0 – 9.4 sec Tol(T) @
15 msec
Time @
0 – 4.7 sec Tol(T) @
7.5 msec
Time @
0 – 2.4 sec Tol(T) @
3.8 msec
Velocity 10 – 600 cm/sec Tol(V)
10% of the velocity or 5 cm/s; whichever is
greater using a J J & A string phantom at
45 degrees ±1 degree.
* Also applies to measurements on MPR (slice) quadrants from acquired volumes.
2D-Mode Measurements
2D-mode
Distance 0 – 34 cm D-Tol(D) D + Tol(D)
Distance Ratio D1/D2 (D1-Tol(D1))/(D2+Tol(D2)) (D1+Tol(D1))/(D2-Tol(D2))
Mean Distance (D1+D2+D3)/3
(D1-Tol(D1)+D2-Tol(D2)+
D3-Tol(D3))/3
(D1+Tol(D1)+D2+
Tol(D2)+D3Tol(D3))/3
Ellipse
Circumference
Ï€{1/2[D1
2
+D2
2
]}
1/2
Ï€{1/2[(D1-Tol(D1))
2
+
(D2-Tol(D2))
2
]}
1/2
Ï€{1/2[(D1+Tol(D1))
2
+
(D2+Tol(D2))
2
]}
1/2
Ellipse Area
π(D1)(D2)/4 π(D1-Tol(D1))(D2-Tol(D2))/4
Ï€(D1+Tol(D1))
(D2+Tol(D2))/4
Ellipse Volume
(D1 = axis of rotation)
(Ï€/6)(D1)(D2)
2
(Ï€/6)(D1-Tol(D1))(D2-
Tol(D2))
2
(Ï€/6)(D1+Tol(D1))
(D2+Tol(D2))
2
Trace Area 0 – 450 cm
A-Tol(A) A+Tol(A)
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