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.

3
Operations & Maintenance Manual: Important Information
SAFETY INFORMATION
ULTRASOUND ENERGY SAFETY
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However,
ultrasound should be used prudently, and total patient exposure should be kept as low as reasonably
achievable (ALARA). Following the ALARA principle, ultrasound should only be used by medical professionals
when clinically indicated, using the lowest possible exposure times necessary to obtain clinically useful
information. For more information on ALARA, please refer to the American Institute of Ultrasound in
Medicine publication, Medical Ultrasound Safety.
The ultrasound output power of the system is not user adjustable and is limited to the minimum
level necessary for effective performance. Data on acoustic output levels can be found in the Product
Specifications section of this manual.
CONTRAINDICATIONS
The AortaScan AMI9700 is not intended for fetal use or for use on pregnant patients.
The AortaScan AMI9700 is not intended for acute events such as aortic dissection, ulcer, or rupture.
PRECAUTIONS & WARNINGS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of
the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction,
failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as
these contain reminders or summaries of the following cautions as they apply to a specific component or
usesituation. Please heed the following warnings and cautions.
PRECAUTIONS
The AortaScan AMI9700 and related devices may contain mineral oils, batteries, and other
environmentally hazardous materials. When the instrument and/or accessories have reached the
end of their useful service life, see the section Device Disposal on page63.
CAUTION
When using the AortaScan AMI9700 with optional ScanPoint®software, your computer must
be minimally certified to EN / IEC / CSA / UL60950 or 60101‑1 standards. This configuration
ensures that compliance to the EN/IEC 60601‑1‑1 system standard is maintained. Anyone
connecting additional equipment to the AortaScan AMI9700 signal input port or signal
output port configures a medical system, and is therefore responsible for ensuring that the
system complies with EN/IEC 60601‑1‑1. If you need assistance, contact your biomedical staff,
Verathon®representative, or Verathon Customer Care.
CAUTION

4
Potential Device Interference. Bluetooth and Wireless LAN devices operate within the same
radio frequency range and may interfere with one another.
If you are using the AortaScan AMI9700 Bluetooth link and wireless LAN devices
simultaneously, you may experience less‑than‑optimal network performance or even lose
your network connection. If this happens, you may need to move the AortaScan AMI9700
and ScanPoint®host computer to an area away from the 2.4 GHz wireless LAN devices (40
meters/44 yards, or more).
CAUTION
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and must be installed and operated according to the instructions in this
manual. For more information, see the Electromagnetic Compatibility section on page72.
To maintain electromagnetic interference (EMI) within certified limits, the AortaScan AMI9700
system must be used with the cables, components, and accessories specified or supplied
by Verathon®. For additional information, see the System Components & Accessories and
Component Specifications sections. The use of accessories and/or cables other than those
specified or supplied may result in increased emissions and/or decreased immunity of the
system.
The AortaScan AMI9700 system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the system should be observed to verify
normal operation in the configuration in which it will be used.
This device can radiate radio frequency energy and is very unlikely to cause harmful interference
with other devices in the vicinity. There is no guarantee that interference will not occur in a
particular installation. Evidence of interference may include degradation of performance in
this device or other devices when operated simultaneously. If this occurs, try to correct the
interference by using the following measures:
• Turn devices on and off in the vicinity to determine the source of interference
• Reorient or relocate this device or other devices
• Increase the separation between devices
• Connect the device to an outlet on a circuit different than the other device(s)
• Eliminate or reduce EMI with technical solutions (such as shielding)
• Purchase medical devices that comply with IEC 60601‑1‑2 EMC Standards
Be aware that portable and mobile radio frequency communications equipment (cellular phones,
etc.) may affect medical electrical equipment; take appropriate precautions during operation.
CAUTION

5
Operations & Maintenance Manual: Important Information
Use of the following cleaning methods or solutions may cause device damage not covered by
the AortaScan AMI9700 warranty.
• Do not immerse the instrument in disinfectant solution.
• Do not use Cidex Plus®to disinfect the instrument. Cidex Plus will damage the plastic enclosure.
• Do not subject any part of the instrument to steam sterilization or ethylene oxide sterilization.
CAUTION
WARNINGS
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
Risk of explosion. If you use the AortaScan AMI9700 in the presence of flammable
anesthetics, the hazard of potential explosion exists.
WARNING
Risk of electric shock or burns. Do not use the AortaScan instrument in conjunction with HF
surgical equipment.
WARNING
Ensure proper distance from patient. The AMI9700 battery charger/wireless hub and the
computer used to access online ScanPoint®image archives (if used) must be placed outside the
patient vicinity (more than 2m [6ft] from the patient).
WARNING

6
Risk of explosion, fire, or serious injury. The AortaScan AMI9700 is powered by a lithium‑ion
battery. Failure to note the following when handling the battery may result in seriousinjury:
• Never short‑circuit the battery by either accidentally or intentionally bringing the battery
terminals into contact with any other conductive object. This could cause serious injury or fire
and could also damage the battery and/or the instrument.
• Never expose the battery to abnormal shock, vibration, or pressure. The battery’s internal
protective covering could fail, causing it to overheat or ignite, resulting in caustic liquid
leakage, explosion, or fire.
• Do not disassemble, heat above 60°C (140°F), or incinerate the battery. Keep battery out
of reach of children and in original package until ready to use. Dispose of used batteries
promptly according to local recycling or waste regulations.
• If the battery is leaking or its case is cracked, put on protective gloves to handle it, and
discard it immediately. Always dispose of used batteries in compliance with all applicable
laws and regulations. Put insulating tape, such as cellophane tape, on the electrodes during
transportation in order to avoid a possible short circuit, fire, or electrical shock.
WARNING
Do not use the AortaScan AMI9700 on:
• A patient who has open skin or wounds in the mid‑abdominal area.
• A patient with ascites.
• A pregnant patient.
WARNING
Potential patient hazard. To date, exposure to low‑power, pulsed diagnostic ultrasound has not
been shown to produce adverse effects. However, medical professionals should use ultrasound
only when clinically indicated, using the lowest exposure times possible to obtain proper
measurements. The ultrasonic output of the AortaScan AMI9700 is not user adjustable and is
limited to the minimum level necessary for effective performance. For more information about the
acoustic output levels of this device, see the section Product Specifications on page68.
WARNING
Ensure that you follow the manufacturer’s instructions for handling and disposing of the
cleaning and disinfection solutions provided in this manual.
WARNING

7
Operations & Maintenance Manual: Important Information
Risk of inaccurate measurements/results. When using the instrument, be aware of the
following conditions that can decrease the accuracy of exam results:
• In some cases, the normal operating tolerances of the instrument can cause it to report a
falsely normal or abnormal measurement. For more information, see Interpret the Aortic
Measurement Results on page51.
• Visual verification that the aorta position is fully within the scan cone on the displayed
images is important.
• A thrombus (blood clot) can complicate aortic measurements. A soft, blood‑like thrombus
may appear as part of the lumen. However, a calcified thrombus may appear as part of the
aorta’s wall, resulting in a measurement of lumen diameter that is smaller than the aorta
diameter. Accordingly, in patients where thrombus is known or suspected, other imaging
methods should be used prior to ruling out an aneurysm.
• Use care when scanning patients who have had abdominal surgery. Scar tissue, surgical
incisions, sutures, and staples can affect ultrasound transmission and accuracy.
• Ensure that the patient fasts for 12 hours prior to undergoing an aortic diameter
measurement in order to minimize the presence of bowel gas, which may obstruct proper
measurement.
• Obesity may affect ultrasound aortic diameter measurements. For more information, see
Obesity on page54.
Accuracy is compromised if the user does not obtain an optimal, repeatable image.
WARNING
Cleaning is critical to ensuring the component is ready for disinfection. Failure to
properly clean the device could result in a contaminated instrument after completing the
disinfectionprocedure.
WARNING
This product may only be cleaned and disinfected by using the approved processes provided in
this manual. Cleaning and disinfection methods listed are recommended by Verathon®based on
compatibility with component materials.
WARNING
Availability of cleaning and disinfection products varies by country, and Verathon is unable
to test products in every market. For more information, please contact Verathon Customer
Care at 1.800.331.2313 or your local representative. For additional contact information, visit
verathon.com/contact‑us.
WARNING

8
INTRODUCTION
COMPONENTS & FEATURES
The AortaScan AMI9700 is designed for simple, intuitive operation. However, to ensure safe and effective
operation, before using the device:
• Familiarize yourself with the contents of this manual.
• Watch the training video provided on the instrument.
The AortaScan AMI9700 has two main components: the console and the probe. The console and probe are
linked by a detachable cable.
Figure 1. AortaScan AMI9700 System Components
Console
Probe
Battery charger/
wireless hub
Battery packs

9
Operations & Maintenance Manual: Introduction
PROBE COMPONENTS
The probe transmits and receives ultrasound waves, automatically moving its internal probe 360º to scan
twelve different planes to produce a three‑dimensional image of the aorta. The probe is attached to the
console by a cable.
Figure 2. Probe Components
Scan button
Aiming display
Microphone (above aiming display)
Table 2. Probe Components
PART NAME PURPOSE
Scan button When pressed, a scan is performed.
Aiming display Displays directional arrows to ensure the aorta is centered within the scanning cone.
Microphone Records voice annotations.

10
CONSOLE COMPONENTS
The console provides all operating controls for the scanning process by means of five variable‑function
buttons. The measured aortic diameter and target‑shaped aiming icons are clearly displayed on the LCD
screen. The console also provides controls for adjusting brightness and volume, turning the power on/off,
interfacing with a ScanPoint®host computer (optional), and adjusting user settings and preferences. The
console also houses the battery and the printer.
Figure 3. Console Components
Main display
Battery pack
Brightness button
Power button
Battery status indicator
Printer (behind display)
Volume button
Five variable
function buttons
Table 3. Console Components
PART NAME PURPOSE
Main display Displays the aortic volume measurement, patient type, settings, and instrument
status.
Power on/off Toggles main power on/off.
Volume Adjusts volume up/down on voice annotation playback, start up sound, and “scan
complete” tone.
Brightness Adjusts display brightness dimmer/brighter.
Five variable function
buttons
Provides access to all instrument functions for scanning, recording annotations,
printing, connecting to ScanPoint®(optional), accessing the training video, and
setting user preferences.
Printer/printer door Prints the scan results.

11
Operations & Maintenance Manual: Introduction
BATTERY CHARGER/WIRELESS HUB
The AortaScan AMI9700 is powered by a lithium‑ion battery. The battery charger provided with the
AMI9700 can charge two lithium‑ion batteries while simultaneously functioning as the wireless hub linking
the AMI9700 to the ScanPoint®host computer. A battery icon on the instrument display is always present
indicating how much power remains and when the battery needs to be changed. The user can change the
battery whenever necessary. Removing a discharged battery and replacing it with a fully charged battery will
not erase any saved exams or user settings.
To provide power to the batteries, the battery charger/wireless hub must be plugged into a wall outlet by
using the power cord provided. Use only the battery charger provided with the AMI9700. Any other battery
charger may damage the battery. The battery charger automatically detects whether a lithium‑ion battery is
being charged.
To provide wireless communication between the AMI9700 and the ScanPoint host computer, plug the
battery charger/wireless hub USB connector into a USB port on the ScanPoint host computer. The battery
charger/wireless hub maintains an operating distance of up to 120 feet (36 meters) between the ScanPoint
computer and the AMI9700, regardless of barriers such as walls, ceilings, or windows.
Note: Use of ScanPoint with QuickPrint software is optional.
Figure 4. Battery Charger/Wireless Hub
Table 4. Battery Charger/Wireless Hub Components
PART NAME DESCRIPTION
Battery charger/
wireless hub
Charges the lithium‑ion batteries and receives and sends information to/from the
AMI9700 instrument within communication range.
Lithium‑ion batteries When charged, provides power to the AMI9700 device.
Power cord Connects the battery charger/wireless hub to the wall outlet.
Wireless hub USB
cable Connects the battery charger/wireless hub to the ScanPoint host computer.

12
SYSTEM COMPONENTS & ACCESSORIES
Table 5. Components and Accessories
COMPONENTS
AMI9700 console
AMI9700 probe
Battery charger/wireless hub with AC power cord
ACCESSORIES
Lithium‑ion battery (2 provided)
AortaScan AMI9700 In‑Service CD or USB, containing the Operations & Maintenance Manual
Thermal paper roll for the printer
Ultrasound gel
Mobile cart (Optional)
Universal accessory basket (Optional)
ScanPoint®with QuickPrint software install CD (Optional)
ScanPoint with QuickPrint user’s manual (Optional)
Calibration kit (Includes calibration container, calibration target, etc.) (Optional)
To order any of the above parts or accessories, contact your authorized Verathon®sales representative or
contact Verathon Customer Care.