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BLUETOOTH WIRELESS TECHNOLOGY

The Bluetooth

®

technology used in the AortaScan AMI 9700 is compliant with:

• Bluetooth Specification as defined and approved by The Bluetooth Special Interests Group.
• Logo certification with Bluetooth wireless technology as defined by The Bluetooth Special Interest

Group.

ELECTROMAGNETIC COMPATIBILITY

The AortaScan AMI 9700 system is designed to be in compliance with IEC 60601‑1‑2:2007, which contains
electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions
and immunity specified in this standard are designed to provide reasonable protection against harmful
interference in a typical medical installation.

The AortaScan AMI 9700 system complies with the applicable essential performance requirements specified
in IEC 60601‑1 and IEC 60601‑2‑37. Results of immunity testing show that the essential performance of
the system is not affected under the test conditions described in the following tables. For more information
about the essential performance of the AortaScan AMI 9700 system, see

Essential Performance

on

ELECTROMAGNETIC EMISSIONS

Table 26. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The AortaScan AMI 9700 system is intended for use in the electromagnetic environment specified below.
The customer or the user of the AortaScan AMI 9700 system should assure that it is used in such an
environment.

EMISSIONS TEST

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

RF emissions
CISPR 11

Group 1

The AortaScan AMI 9700 system uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.

RF emissions
CISPR 11

Class A

The AortaScan AMI 9700 system is suitable for use in all
establishments other than domestic and those directly connected
to the public low‑voltage power supply network that supplies
buildings used for domestic purposes.

Harmonic emissions
IEC 61000‑3‑2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000‑3‑3

Complies

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Содержание AORTASCAN AMI 9700

Страница 1: ...AORTASCAN AMI 9700 Operations Maintenance Manual...

Страница 2: ...0900 4411 04 60...

Страница 3: ...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...

Страница 4: ...yright 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 V...

Страница 5: ...ssential 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...

Страница 6: ...he 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...

Страница 7: ...nt 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...

Страница 8: ......

Страница 9: ...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...

Страница 10: ...aScan 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 th...

Страница 11: ...icate 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 fail...

Страница 12: ...ified 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...

Страница 13: ...d 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 ultrasou...

Страница 14: ...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 trans...

Страница 15: ...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 minimiz...

Страница 16: ...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...

Страница 17: ...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 PA...

Страница 18: ...ttery 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 Display...

Страница 19: ...mage 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 th...

Страница 20: ...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 ScanPoi...

Страница 21: ...st 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 imag...

Страница 22: ...alled 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 recorde...

Страница 23: ...Add and or toggle characters as appropriate Remove and or toggle characters as appropriate Select the Axis on which to manually measure the aorta Go to the manual measurement tool and select appropri...

Страница 24: ...ulated aortic diameter in centimeters the ultrasound image of the scan and available memory An hourglass icon appears when the device is printing 1 Record press to record changes to a stop button duri...

Страница 25: ...urrently selected character 5 Settings return to main settings screen Date and Time screen Allows the user to set the date and time 1 Down Arrow move forward to next editable unit 2 Up Arrow move back...

Страница 26: ...ime On the left side A list of saved exam results 10 maximum saved in chronological order Yellow folders hold saved exams Grey folders represent empty spaces still available for saving exam results Ta...

Страница 27: ...d annotated exams will be automatically uploaded to the host computer Note ScanPoint software must be previously installed and the computer must be connected to the wireless hub Use of the ScanPoint s...

Страница 28: ...ppears on the main display as an yellow folder icon Depending on the Print Report Type selected see General Preferences Screen the Results screen will show one of two displays Figure 5 B Mode Report T...

Страница 29: ...ng modules Note When this screen is open the Scan button on the probe is disabled Table 9 Tutorial Screen Button Functions BUTTON FUNCTION Move down one title or skip back one chapter in the training...

Страница 30: ...Press the Play button to begin the desired tutorial Note When this screen is open the Scan button on the probe is disabled Table 10 Video Viewing Screen Button Functions BUTTON FUNCTION No function Pl...

Страница 31: ...ts a list of user configurable settings Name Date Time General Preferences and Self Test Note When this screen is open the Scan button on the probe is disabled Table 11 Settings Screen Button Function...

Страница 32: ...institution s name For more information see Program the Clinic Name on page 37 Table 12 Name Screen Button Functions BUTTON FUNCTION Move down in the grid Move right in the grid Add the highlighted ch...

Страница 33: ...is set to show a 12 hour clock the hour units are 01 12 Table 13 Date Time Screen Button Functions BUTTON FUNCTION Move back one changeable unit Move to the next changeable unit Add and or toggle dig...

Страница 34: ...l appear in the display header when the device requires calibration Print Report Type Toggle between C mode images aorta in crosshairs and B mode images image of aorta and abdominal space below probe...

Страница 35: ...ions BUTTON FUNCTION Move down a setting in the list Move up a setting in the list Select the next option Press and hold to move through options more quickly Select the previous option Press and hold...

Страница 36: ...begins automatically Once testing is complete data on the screen is printed automatically to the instrument s onboard printer Table 15 Self Test Screen Button Functions BUTTON FUNCTION No function No...

Страница 37: ...version 3 0 or higher Software updates may be performed by either logging on to ScanPoint or by contacting Verathon Customer Care The scan counter may be monitored as a part of a regular device maint...

Страница 38: ...in the instrument s internal memory If one of the storage locations fails the text EEPROM Failed will be added to the DSP status line In the event of an EEPROM failure the counter will continue to wor...

Страница 39: ...e screen The ScanPoint screen displays information about the status of the link between the AortaScan instrument and the ScanPoint host computer Figure 10 ScanPoint Screen Searching Figure 11 ScanPoin...

Страница 40: ...atically when not in use After four minutes of idle time a sleep mode alert message displays for 15 seconds While the message is displayed press any button to keep the console awake and dismiss the me...

Страница 41: ...e 1 PERFORM THE INITIAL INSPECTION When you receive the AortaScan AMI 9700 system Verathon recommends that an operator familiar with the instrument perform a full visual inspection of the system for a...

Страница 42: ...ape on the electrodes during transportation in order to avoid a possible short circuit fire or electrical shock WARNING Ensure proper distance from patient The AMI 9700 battery charger wireless hub an...

Страница 43: ...d battery Indicates a battery 50 to 75 charged Indicates a battery 25 to 50 charged Indicates a battery is almost depleted Can power a few more scans Indicates that a battery should be replaced immedi...

Страница 44: ...e cable connector to the top of the cable port Arrow on cable connector 3 Gently push the connector ring into the port until the cable clicks into place and is secure The cable can remain attached to...

Страница 45: ...included on the console display and all printouts of exam results 1 Turn the AortaScan AMI 9700 on by pressing the Power button on the front of the console 2 When the Home screen appears press the Se...

Страница 46: ...5 When finished press the Settings button to return to the Settings screen From the Settings screen press the Home button to return to the Home screen The facility name will now appear in the display...

Страница 47: ...On the Date and Time screen use the Up Arrow button and Down Arrow button to move to the desired unit hours minutes month day year When the desired unit is highlighted press the Plus button to increa...

Страница 48: ...nsole behind the display 2 Slide the door to the right then lift up 3 If there is an empty paper roll remove it 4 In the paper well insert the end of a new paper roll with the thermal side down 5 Exte...

Страница 49: ...mobile cart will allow you to move the AortaScan along with related accessories to the patient examining area or bedside as necessary Figure 12 Assembled Medical Cart Figure 13 Medical Cart Assembly T...

Страница 50: ...cart refer to Step 13 through Step 15 PERMANENTLY ATTACH THE POST TO THE WHEELED BASE OPTIONAL 6 Place medical cart base on level ground 7 Open the two tubes of Loctite 680 by snapping off the tips o...

Страница 51: ...lly downloads exam data to the ScanPoint host computer via a wireless connection enabled by the battery charger wireless hub allowing further viewing analysis archiving and report generation To instal...

Страница 52: ...l 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...

Страница 53: ...t when compared to other alternatives like CT CTA MRI MRA or standard ultrasound performed by trained sonographers The AortaScan AMI 9700 can measure diameters ranging between 3 0 and 12 4 cm with a d...

Страница 54: ...duction chapter on page 8 2 Check the instrument battery icon to ensure the battery has sufficient power If the battery icon is full or less replace the battery with a freshly charged battery before p...

Страница 55: ...lected scan locations 4 Standing at the patient s right side place the probe on the gel at the first position 5 Hold the probe with the long axis aligned with the midline of the abdomen Do not hold th...

Страница 56: ...er exam press the Home button and then repeat this procedure If you would like to measure abdominal aortic diameter manually complete the procedure Measure Aortic Diameter Manually Optional on page 49...

Страница 57: ...Mode Return 2 By using the following button controls move one cursor to the right edge of the aorta and move the other cursor to the opposite edge of the aorta Press the Axis Select button to swap bet...

Страница 58: ...saved 4 Press the Listen button The voice annotation plays If you are not satisfied with the recording press the Record button again to record a new annotation Note You can make a new recording only i...

Страница 59: ...agnostic standard confirmatory test regardless of test results WARNING 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...

Страница 60: ...aorta relative to the probe as viewed looking from the probe into the body The aorta is shown in red and bowel gas is shown as white lines The green dot on the left side is the reference mark correla...

Страница 61: ...ack of any arrows telling the user to re aim the probe mean the user can feel confident that the lack of diameter information is due to a small aorta and not due to the presence of bowel gas In this c...

Страница 62: ...rocking motion to try and displace any bowel gas obscuring the aorta Do not move the probe while the scan is in progress as that will decrease the accuracy of the measurement If rescanning is not suc...

Страница 63: ...tomer Care at 1 800 331 2313 or your local representative For additional contact information visit verathon com contact us WARNING Ensure that you follow the manufacturer s instructions for handling a...

Страница 64: ...is based on the type of tissue it contacts during use Based on the intended use of the AortaScan AMI 9700 low level disinfection is the minimum level required 1 Ensure the instrument has been properl...

Страница 65: ...e console probe or the cable that links the console and the probe must be referred to your authorized AortaScan Service Center your local Verathon distributor your local Verathon representative or Ver...

Страница 66: ...the ScanPoint button 2 On the computer double click the ScanPoint with QuickPrint icon ScanPoint opens 3 On the computer in the ScanPoint QuickPrint window click Find New QuickPrint establishes a con...

Страница 67: ...any updates are available the device downloads and installs them The console displays a progress bar and automatically restarts when the installation is complete If no updates are available nothing h...

Страница 68: ...s not performed by the prescribed date the instrument can still be used to take scans but measurements may be compromised When calibration is required a warning appears in the display header Figure 23...

Страница 69: ...click the ScanPoint with QuickPrint icon ScanPoint opens 7 On the console on the Home screen press the ScanPoint button 8 On the computer in the ScanPoint QuickPrint window click Find New QuickPrint e...

Страница 70: ...s the device you are calibrating and then click the calibration tank icon 10 Click the Calibrate button ScanPoint begins to scan and analyze the data in order to ensure that it meets the calibration p...

Страница 71: ...n the console click the Exit button This terminates the calibration procedure and ends communication with ScanPoint QuickPrint 13 Remove the probe from the calibration lid and then dry it with a clean...

Страница 72: ...list of Customer Care resources available at verathon com contact us DEVICE REPAIR The AortaScan AMI 9700 console probe and battery charger wireless hub are completely sealed There are no user servic...

Страница 73: ...le does not connect continue to the next step 2 Turn the console off turn the console on and then press the ScanPoint button On the PC in ScanPoint click Find New If the console does not connect conti...

Страница 74: ...ry capacity For this reason Verathon recommends replacing the existing batteries with new batteries every two years If the instrument has stopped responding even with a new battery perform a full rese...

Страница 75: ...ormance with Verathon product specifications as provided in the Product Specifications chapter For further details consult your Premium Warranty Warranty conditions may differ in some countries outsid...

Страница 76: ...Ultrasound Acoustic Output Parameters Values in this table are the maximum readings obtained from three test results ACOUSTIC OUTPUT MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 519 0 632 9...

Страница 77: ...nning a tissue equivalent phantom Table 23 Operating Storage Conditions SPECIFICATION DESCRIPTION Operating Conditions Use Indoor Ambient temperature range 10 40 C 50 104 F Atmospheric pressure range...

Страница 78: ...s change reset them using the instructions in the Setting Up chapter Use only the battery charger provided with the AMI 9700 Any other battery charger may damage the battery Table 24 Battery Specifica...

Страница 79: ...pheric pressure range 700 hPa 106 hPa Relative humidity 30 75 non condensing Water resistance Rated at IPX 0 ordinary equipment without protection against ingress of water Computer connection USB 2 0...

Страница 80: ...he test conditions described in the following tables For more information about the essential performance of the AortaScan AMI 9700 system see Essential Performance on page 2 ELECTROMAGNETIC EMISSIONS...

Страница 81: ...should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut...

Страница 82: ...owing symbol Note Ut is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromag...

Страница 83: ...12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transm...

Страница 84: ...electric shock Flammable material Non ionizing electromagnetic radiation Product Use Specifications Refer to the operations maintenance manual Manufacturer Date of manufacture Use by date Catalog part...

Страница 85: ...k of certification to applicable standards for electromedical equipment FCC Tested to Federal Communications Commission requirements EC REP Authorized Representative in the European Community WEEE Sub...

Страница 86: ...t hPa Hectopascal Hz Hertz IEC International Electrotechnical Commission Image cone Cone shaped area in which the probe transmits ultrasound waves in Inch ISM Industrial scientific and medical ISPPA S...

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