Verathon AORTASCAN AMI 9700, Operation & Maintenance Manual

Page: 59 / 88

51
Operations & Maintenance Manual: Using the Device
PROCEdURE 5. INTERPRET THE AORTIC MEASUREMENT RESULTS
The aortic diameter measurement function provides images that may be used for diagnosis and
screening. If clinically indicated, appropriate patients should be referred for additional diagnostic
testing.
WARNING
The AortaScan system is designed to detect the fluid (blood) filled region of the abdominal
aorta only. The system cannot detect the presence of a blood clot (thrombus) and therefore may
provide a false negative result.
WARNING
The AortaScan system is an ultrasound‑based device and is subject to all limitations of this
method. If clinically indicated, appropriate patients should be referred for a diagnostic standard
(confirmatory) test, regardless of test results.
WARNING
The AortaScan AMI 9700 can measure diameters ranging between 3 and 12.4 cm with a diameter accuracy
of ± (15% + 0.5 cm). This error‑range data (
Table 19 ) indicates a range of values obtained by the device
relative to follow up and clinical significance, specifically with respect to risk vs. diameter.
Table 19. Expected Aortic Measurement Ranges
ACTUAL AORTIC DIAMETER
3.0 cm 3.5 cm 4.0 cm 4.1 cm 5.0 cm 5.3 cm
Average
estimated risk
of rupture for
actual aortic
diameter
0% 0% 0% 1% 11% 11%
Aortic diameter as reported by the device based on allowable tolerances
Min Max Min Max Min Max Min Max Min Max Min Max
± 15% 2.55 3.45 2.98 4.03 3.40 4.60 3.49 4.72 4.25 5.75 4.51 6.10
With additional
±0.5 cm
2.05 3.95 2.48 4.53 2.90 5.10 2.99 5.22 3.75 6.25 4.01 6.60
Average
estimated risk
of rupture for
reported aortic
diameter
0% 0% 0% 1% 0% 1% 0% 11% 0% 26%
0.5–
5.0%
26%