Verathon AORTASCAN AMI 9700, Руководство по эксплуатации и техническому обслуживанию

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Operations & Maintenance Manual: Important Information
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The AortaScan AMI 9700 is a portable ultrasound instrument that provides noninvasive measurements of
abdominal aortic diameter. The device consists of an ultrasound probe that scans the patient’s aorta, and a
compact, battery‑operated console that provides measurement‑related information.
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 1 ) indicates a range of values obtained by the device
relative to follow up and clinical significance, specifically with respect to risk vs. diameter.
Table 1. 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%
Note: The AortaScan AMI 9700 is not intended to detect, identify, screen for, or diagnose abdominal aortic
aneurysms (AAAs).
The AortaScan AMI 9700 is quick and easy to use. When the user releases the scan button, the AortaScan
AMI 9700 uses patented V
mode
®
technology to measure ultrasound reflections on multiple planes inside
the body and produces a three‑dimensional image within seconds. Based on this image, the AortaScan
AMI 9700 calculates and displays the approximate abdominal aortic diameter. A sonographer is not required.
If needed, after a scan has been taken, a unique aiming icon guides the operator to optimal probe placement
with a comprehensive, three‑dimensional display showing the aorta in two cross‑sectional images verifying
that a complete scan has been achieved.