Verathon AORTASCAN AMI 9700 Manual

AORTASCAN
AMI9700
Operations & Maintenance Manual

0900‑4411‑04‑60

AORTASCAN
AMI9700
Operations & Maintenance Manual
Effective: November 2, 2015
Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.

CONTACT INFORMATION
To obtain additional information regarding your AortaScan system,
please contact Verathon®Customer Care or visit verathon.com/contact‑us.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 U.S.A.
800.331.2313 (US and Canada only)
425.867.134 8
Fax: [phone]
verathon.com
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam
The Netherlands
Tel: [phone]
Fax: [phone]
verathon.com
0123
Copyright 2009, 2015 Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without
the express written consent of Verathon Inc.
AortaScan, the AortaScan symbol, Vmode, Verathon, and the Verathon Torch symbol are trademarks of Verathon Inc. Bluetooth®word
mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Verathon is under license. All other brand and
product names are trademarks or registered trademarks of their respective owners.
Information in this manual may change at any time without notice. For the most up‑to‑date information, see the documentation
available at verathon.com.

i
Operations & Maintenance Manual: Table of Contents
TABLE OF CONTENTS
IMPORTANT INFORMATION.................................................................................................................................1
Overview ............................................................................................................................................................1
Product Description .........................................................................................................................................1
Notice to All Users ...........................................................................................................................................2
Statement of Prescription.................................................................................................................................2
Statement of Intended Use ..............................................................................................................................2
Essential Performance ......................................................................................................................................2
Safety Information ..............................................................................................................................................3
Ultrasound Energy Safety.................................................................................................................................3
Contraindications.............................................................................................................................................3
Precautions & Warnings ...................................................................................................................................3
INTRODUCTION ....................................................................................................................................................8
Components & Features......................................................................................................................................8
Probe Components..........................................................................................................................................9
Console Components ....................................................................................................................................10
Battery Charger/Wireless Hub ........................................................................................................................ 11
System Components & Accessories ................................................................................................................... 12
Icons & Buttons ................................................................................................................................................ 13
Console Display Icons..................................................................................................................................... 13
Variable Button Functions .............................................................................................................................. 14
Button Functions for Each Display Screen .......................................................................................................16
Display Screens .................................................................................................................................................18
Sleep Mode ......................................................................................................................................................32

ii
SETTING UP .........................................................................................................................................................33
Procedure 1. Perform the Initial Inspection ...............................................................................................33
Procedure 2. Set Up the Battery ...............................................................................................................34
Procedure 3. Attach the Probe to the Console ..........................................................................................36
Procedure 4. Program the Clinic Name ..................................................................................................... 37
Procedure 5. Set the Date & Time.............................................................................................................39
Procedure 6. Load the Thermal Paper .......................................................................................................40
Procedure 7. Attach the Instrument to a Medical Cart (Optional) .............................................................. 41
Procedure 8. Install ScanPoint with QuickPrint (Optional) .........................................................................43
Procedure 9. Watch the Training Video.....................................................................................................43
USING THE DEVICE .............................................................................................................................................44
Procedure 1. Prepare for the Exam ...........................................................................................................46
Procedure 2. Measure Abdominal Aortic Diameter ................................................................................... 47
Procedure 3. Measure Aortic Diameter Manually (Optional) ......................................................................49
Procedure 4. Save, Review, & Print Exam Results.......................................................................................50
Procedure 5. Interpret the Aortic Measurement Results ............................................................................ 51
CLEANING & MAINTENANCE .............................................................................................................................55
Cleaning & Disinfecting.....................................................................................................................................55
Procedure 1. Clean the Instrument ...........................................................................................................55
Procedure 2. Disinfect the Instrument.......................................................................................................56
Regular Inspections...........................................................................................................................................57
Maintenance.....................................................................................................................................................57
Procedure 1. Run a Self Test.....................................................................................................................57
Procedure 2. Update the Software ...........................................................................................................58
Procedure 3. Calibrate the Probe Using the ScanPoint System ...................................................................60
Device Disposal.................................................................................................................................................63

iii
Operations & Maintenance Manual: Table of Contents
TROUBLESHOOTING ...........................................................................................................................................64
Help Resources .................................................................................................................................................64
Device Repair....................................................................................................................................................64
Troubleshooting Procedures ..............................................................................................................................65
Procedure 1. Troubleshoot ScanPoint Connection .....................................................................................65
Procedure 2. Troubleshoot Power Issues ...................................................................................................66
Procedure 3. Instrument Too Hot..............................................................................................................66
Procedure 4. Clear a Paper Jam ................................................................................................................66
WARRANTY.........................................................................................................................................................67
PRODUCT SPECIFICATIONS.................................................................................................................................68
Component Specifications ................................................................................................................................68
Console & Probe Specifications ......................................................................................................................68
Battery Specifications.....................................................................................................................................70
Battery Charger/Wireless Hub Specifications ..................................................................................................71
Bluetooth Wireless Technology..........................................................................................................................72
Electromagnetic Compatibility...........................................................................................................................72
Electromagnetic Emissions .............................................................................................................................72
Electromagnetic Immunity .............................................................................................................................73
Recommended Separation Distances..............................................................................................................75
Accessory Conformance to Standards.............................................................................................................75
SYMBOL DIRECTORY ..........................................................................................................................................76
GLOSSARY ...........................................................................................................................................................78

1
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 Vmode®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.

2
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.