Verathon BladderScan i10, Operation & Maintenance Manual

Page: 84 / 96

76
0900‑5005 REV‑00
Table 17. Ultrasound Acoustic Output Parameters (FDA Format)
The data in each column corresponds to the highest measured global maximum value for each of the
parameters in the column title (MI,
I
spta.3
, I
sppa.3
), measured for three probes.
ACOUSTIC OUTPUT MI
I
SPTA.3
(mW/cm
2
)
I
SPPA.3
(W/cm
2
)
Global Maximum Value
*
0.455 0.181 12.2
Associated
Acoustic
Parameter
p
r.3
(MPa) 0.682
P
0
(mW) 0.863 0.863
f
c
(MHz) 2.29 2.29 2.29
z
sp
(cm) 3.40 3.40
Beam dimensions
x
‑6
(cm)
0.401
y
‑6
(cm) 0.401
PD (µsec) 0.753 0.753
PRF (Hz) 408 408
EDS
Az. (cm) 5.25
Ele. (cm) 1.28
* MI and TI values are both below 1.0.
ACCURACY SPECIFICATIONS
Table 18. Accuracy Specifications
SPECIFICATION DESCRIPTION
Bladder volume range 0 to 999 mL
Volume accuracy
greater than 100 mL ± 7.5%
0–100 mL ± 7.5 mL
The following examples show how the accuracy ranges shown in Table 18 may affect reported volume
measurements.
• If the measurement is greater than 100 mL, the accuracy range is ± 7.5% and is calculated as follows:
240 mL × 7.5% = 18 mL
240 ± 18 mL =
222–258 mL
• If the measurement is 0–100 mL, the accuracy range is ± 7.5 mL and is calculated as follows:
80 mL ± 7.5 mL = 73–88 mL (rounded to the nearest whole number)
The accuracy specifications assume the system is being used according to the instructions provided by
Verathon while scanning a tissue‑equivalent phantom.
While the upper threshold of the accuracy range is 999 mL, the system is capable of detecting and displaying
bladder volumes above 999 mL. Verathon cannot guarantee the accuracy of measurements outside of the
stated specifications.