Verathon AORTASCAN AMI 9700, Operation & Maintenance Manual

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AortaScan AMI 9700 measurements can be printed via an onboard thermal printer or transmitted, via
a proprietary wireless connection, to a personal computer running HIPAA‑compliant ScanPoint
®
with
QuickPrint software. ScanPoint with QuickPrint software enables the user to print detailed reports for medical
records or reimbursement, calibrate the instrument (requires a calibration kit), download and install software
updates, and archive data on Verathon
®
servers.
The optional calibration kit, consisting of a spiral‑shaped calibration target along with a special calibration
container, allows the user to easily calibrate the device at their facility by scanning a known target.
The AortaScan AMI 9700 system also includes a battery charger/wireless hub for the custom,
user‑replaceable lithium‑ion battery that mounts in the console.
The AortaScan AMI 9700 may be mounted on a cart which holds the instrument securely in place and
provides a holder for ultrasound gel and other accessories.
NOTICE TO ALL USERS
The AortaScan AMI 9700 should be used only by individuals who have been trained and authorized by a
physician or the institution providing patient care. All users must read this entire manual prior to using the
AMI 9700. Do not attempt to operate this instrument until you thoroughly understand all instructions and
procedures in this manual. Failure to comply with these instructions may compromise the performance of the
device and the reliability of its measurements.
For the most current version of this manual, please visit verathon.com .
STATEMENT OF PRESCRIPTION
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
STATEMENT OF INTENDED USE
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid‑abdomen to
obtain an image of the abdominal aorta for aortic diameter measurements.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The
essential performance of the AortaScan AMI 9700 system is to produce ultrasonic output energy, display
ultrasonic images, and display numerical values for aortic diameter. The system has a temperature‑controlled
transducer assembly.