AMI 9700 Operations & Maintenance Manual May 2014

Operations & Maintenance Manual (0900‑4411-01‑60) for AortaScan AMI 9700 system (0270-0636)

AORTASCAN

AMI 9700

OPERATIONS & MAINTENANCE MANUAL Effective: May 29, 2014

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. Corporate Headquarters: 20001 North Creek Parkway Bothell, WA 98011 U.S.A. 800.331.2313 (US and Canada only) 425.867.1348 Fax: 425.883.2896 verathon.com

Verathon® Medical (Europe) B.V. Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512 verathon.eu

Copyright© 2014 by Verathon Inc. All rights reserved. AortaScan, the AortaScan symbol, VMODE, Verathon, and the Verathon Torch symbol are trademarks of Verathon Inc. 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 online manuals at verathon.com.

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TABLE OF CONTENTS IMPORTANT INFORMATION... 1 OVERVIEW... 1 Product Description... 1 Notice to All Users... 1 Statement of Prescription... 2 Statement of Intended Use... 2 Essential Performance... 2 SAFETY INFORMATION... 2 Biological Safety... 2 Contraindications... 2 Cautions & Warnings... 3 INTRODUCTION... 7 COMPONENTS & FEATURES... 7 Probe Components... 8 Console Components... 9 Battery Charger/Wireless Hub...10 SYSTEM COMPONENTS & ACCESSORIES... 11 ICONS & BUTTONS...12 Console Display Icons...12 Variable Button Functions...13 Button Functions for Each Display Screen...15 DISPLAY SCREENS...17 SLEEP MODE...31

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SETTING UP...32 Procedure 1. Perform the Initial Inspection...32 Procedure 2. Set Up the Battery...33 Procedure 3. Attach the Probe to the Console...35 Procedure 4. Program the Clinic Name...36 Procedure 5. Set the Date & Time...38 Procedure 6. Load the Thermal Paper...39 Procedure 7. Attach the Instrument to a Medical Cart (Optional)... 40 Procedure 8. Install ScanPoint with QuickPrint (Optional) ... 42 Procedure 9. Watch the Training Video...42 USING THE DEVICE...43 Procedure 1. Prepare for the Exam...45 Procedure 2. Measure Abdominal Aortic Diameter...46 Procedure 3. Measure Aortic Diameter Manually (Optional)... 48 Procedure 4. Save, Review, & Print Exam Results...49 Procedure 5. Interpret the Aortic Measurement Results... 50 CLEANING & MAINTENANCE...54 CLEANING...54 REGULAR INSPECTIONS...54 MAINTENANCE PROCEDURES...55 Procedure 1. Run a Self Test...55 Procedure 2. Update the Software...56 Procedure 3. Calibrate the Probe Using the ScanPoint System... 58 DEVICE DISPOSAL...61

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TROUBLESHOOTING...62 HELP RESOURCES...62 DEVICE REPAIR...62 TROUBLESHOOTING PROCEDURES...63 Procedure 1. Troubleshoot ScanPoint Connection...63 Procedure 2. Troubleshoot Power Issues...64 Procedure 3. Instrument Too Hot...64 Procedure 4. Clear a Paper Jam...64 WARRANTY...65 PRODUCT SPECIFICATIONS...66 COMPONENT SPECIFICATIONS...66 Console & Probe Specifications...66 Battery Specifications...67 Battery Charger/Wireless Hub Specifications...68 STANDARDS & REGULATIONS COMPLIANCE...69 BLUETOOTH WIRELESS TECHNOLOGY...69 ELECTROMAGNETIC COMPATIBILITY...70 Electromagnetic Emissions...70 Electromagnetic Immunity...71 Recommended Separation Distances...73 SYMBOL DIRECTORY...74 GLOSSARY...76

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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 is quick, accurate, reliable, 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 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. 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.

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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.

SAFETY INFORMATION BIOLOGICAL SAFETY To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However, ultrasound should be used only by medical professionals when clinically indicated, using the lowest possible exposure times indicated by clinical need. The ultrasound output power of the AortaScan AMI 9700 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.

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CAUTIONS & 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. To ensure safe and reliable operation for the user and the patient, please heed the following warnings and cautions. PRECAUTIONS CAUTION 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 61. 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 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 loose 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 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.

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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 70. 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.

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WARNINGS WARNING The device is designed to detect only the fluid-filled (blood) region of the abdominal aorta. It cannot detect the presence of a blood clot (thrombus) and therefore may provide a false negative result. WARNING The AortaScan instrument is an ultrasound-based device and is subject to all limitations of this method. It is an initial screening test; it is not a diagnostic one. When used appropriately in clinically suitable subjects, it will indicate the probable presence of pathological enlargement of the abdominal aorta with “normal” (< 3 cm) displayed and “potentially abnormal” (X.X cm if ≥ 3 cm). 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 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.

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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 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 six feet [2 meters] from the patient). Refer to UL 2601-1 Clause 2 deviation for the definition of patient vicinity. 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 accurate 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 66. WARNING Risk of inaccurate measurements/results. When using the instrument, be aware of the following conditions that can affect ultrasound transmission and decrease the accuracy of exam results: • 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 accurate measurement. • Obesity may affect ultrasound aortic diameter measurements. For more information, see Obesity on page 53. Accuracy is compromised if the user does not obtain an optimal, repeatable image.

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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 and on the in-service CD. 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

Battery packs

Battery charger/ wireless hub

Probe

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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

Microphone (above aiming display)

Aiming display

Scan button

Table 1.

Probe Components

PART NAME

8

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.

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 status indicator

Battery pack

Printer (behind display)

Volume button

Five variable function buttons Brightness button

Power button

Table 2.

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.

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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. The lithium-ion battery will be charged with approximately 11.1 volts (V), which goes up slightly as the battery gets fully charged, and 9.6 amperes (A). 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 3.

Battery Charger/Wireless Hub Components

PART NAME

10

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.

SYSTEM COMPONENTS & ACCESSORIES Table 4.

Parts 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, containing the operations & maintenance manual and a video tutorial Thermal paper roll for the printer Acoustic coupling gel Mobile cart (Optional) Universal accessory basket (Optional) ScanPoint with QuickPrint software install CD (Optional) ScanPoint® with QuickPrint user’s manual, on an in‑service CD (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.

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ICONS & BUTTONS The console LCD presents user information and prompts that vary depending on the current device function. The five buttons below the display have variable functions according to device mode. Button functions are indicated by icons in the display footer, immediately above each button.

CONSOLE DISPLAY ICONS The following icons may appear on the console main display. ICON

PURPOSE

A fully charged battery. A battery 50% to 75% charged. A battery 25% to 50% charged. An almost depleted battery. Can power a few more scans. A fully discharged battery. Replace immediately. Empty exam folder Current exam folder Saved exam folder (Solid arrow) The aorta is contained within the image cone (cone-shaped area in which the probe transmits ultrasound waves), but the presence of bowel gas prevents an accurate measurement. You may be able to obtain a more accurate measurement by moving the probe 1/2 to 1 inch (1 to 2 cm) in the direction indicated by the arrow. (Flashing arrow) The aorta is obstructed by bowel gas and the probe needs to be repositioned. The arrow shows the direction to move or tilt the probe to improve the measurement. Try moving the probe 1/2 to 1 inch (1 to 2 cm) in the direction of the arrow.

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VARIABLE BUTTON FUNCTIONS ICON

PURPOSE

Go to the Home screen. View the training video. Go to the Settings screen. Go to the Review screen. If there are no saved exams, this button is disabled. Initiate communication with the ScanPoint® host computer. Saved and annotated exams will be automatically uploaded to the host computer. Note: ScanPoint software must be previously installed and the computer connected to the wireless hub. Use of the ScanPoint software is optional. Record a voice annotation. Play a previously recorded voice annotation. If no voice annotations are recorded, this button is disabled. Print exam results from the onboard printer. While printing is in progress, an hourglass icon appears on the display, and most buttons are disabled. Move down an item. Move up an item. Move right an item. Delete an exam or cancel the current action. Select the highlighted item. Stop recording a voice annotation. Play video playback. Pause video playback.

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