SuperSonic Imagine AIXPLORER MultiWave Users Guide Rev 12A July 2017

The software used for this system includes software owned by SuperSonic Imagine and licensed to SuperSonic Imagine by a licensor. Availability of this software and related documents is restricted. The software and related documents must be used only for this system. The intellectual property of this software and related documents is not assigned to you. You must not copy the software or documents, nor modify the software in whole or in part. You must not recompile or reassemble the software. You must not assign, disclose, transfer, or sublicense the software or documents to a third party. The ultrasound system software is subjected to the US and French Export and Administration Laws and Regulations and you must not export or reexport the software in whole or in part unless properly authorized by the US or French government. The information in the documents, or programs in the software are subject to change without notice.

 No modification of this equipment is allowed.



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The following names are trademarked or registered by SuperSonic Imagine, Inc: • Aixplorer® • The Theragnostic Company™ • ShearWave™ Elastography • SWE™ Mode • Q-Box™ • UltraFast™ Imaging • SuperCompound™ • UltimateFocus™ • SuperRes™ • TissueTuner™ • SonicTouch™ • SonicSoftware™ • ManualTouchTGC™ • SuperLinear™ 15-4 transducer • SuperLinear™ 18-5 transducer • SuperCurved™ 6-1 transducer • SuperEndocavity™ 12-3 transducer • SuperEndocavity™ Volumetric 12-3 transducer • SuperLinear™ Volumetric 16-5 transducer • SuperLinear™ 10-2 transducer • SuperMicroConvex™ 12-3 transducer • SuperLinear™ HockeyStick 20-6 transducer • TouchRing™ • SonicResearch™ • MultiWave™ • Thy-RADS™ • ReportBuilder™ • UltraFast™ Doppler • PLanewave UltraSensitive™

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 Welcome and congratulations on your purchase of the Aixplorer® Ultrasound System. The following documents are available for the Aixplorer® Ultrasound System: • Quick Guide The Quick Guide contains basic information regarding the use of the product. It does not replace the User's Guide. • User's Guide This User's Guide contains important information regarding the use and safety of the product. Please read this guide carefully and store it in a location where it can be easily accessed. • Fusion/Navigation Guide (optional) The Fusion/Navigation Guide contains important information regarding the use of the fusion/navigation feature. • Obstetrical References The Obstetrical References Guide contains the detailed obstetrical tables and equations that are used on Aixplorer®. The Aixplorer® system has been designed with the safety of the operator and patient in mind. Please read the following chapters thoroughly before you start working with the system. SuperSonic Imagine guarantees the system will perform as intended only when all cautions and warnings specified in this user's guide are observed.

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This user's guide contains important information about the use of your ultrasound system. The features described in this user's guide may be optional. Please contact your local SuperSonic Imagine sales or service representative for further information. Pictures are not contractual and are only displayed for general information purposes. It also contains information about contacting SuperSonic Imagine for support. This guide is intended for use by, or by the order of, and under direct supervision of a licensed physician qualified to direct the use of the ultrasound device. This guide is intended for users who have been trained or are otherwise familiar with the use of medical ultrasound devices. Clinical guidance on how to perform an ultrasound examination is not provided in this manual. This user's guide complies with the following: • 93/42/EEC European Directive modified by 2007/47/EEC European Directive • FDA regulation, 21 CFR § 801

  % In case further information is needed, trainings are advised and available upon request at SuperSonic Imagine. Please contact your local representative for more information.



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! $  The SuperSonic Imagine Aixplorer® system is a cart based ultrasound imaging system used to perform diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements and associated calculations, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner similar to existing devices and transducers for the imaging modes: B-Mode, M-mode, Color Doppler imaging, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Power Doppler imaging, Directional Amplitude Power imaging, Contrast Imaging, Elasticity Imaging, and 3D imaging.

 
 The SuperSonic Imagine Aixplorer® ultrasound system is intended for general purpose pulse echo ultrasound imaging, Doppler fluid flow analysis of the human body, and tissue elasticity imaging of soft tissues.

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 The SuperSonic Imagine Aixplorer® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Non-invasive Cardiac, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics). This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device1. This system should only be used by trained sonographers who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

    The Aixplorer® system is not designed for ophthalmic use or any use causing the acoustic beam to pass through the eye. The use of the Aixplorer® system with a defibrillator is prohibited. The Aixplorer® system is not intended for use with flammable anaesthetics or in conjunction with flammable agents.

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!"  Caution: United States federal law restricts the sale of diagnostic ultrasound devices to sale by or on the order of a physician 1. 1

Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.

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#   According to 93/42/EEC European Directive modified by 2007/47/EEC European Directive, Aixplorer® is a Class IIa Medical Device. According to : • IEC/EN 60601-1, Equipment is Class I, type BF. • IEC 60601-1-2, Equipment is Class A. The product is compliant to the following standards: • UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety • CAN/CSA-C22.2 No. 601.1Medical Electrical Equipment - Part 1: General Requirements for Safety • IEC/EN 60601-1-1 Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems. • IEC/EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests. • IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. • IEC 62304 Medical device software – Software life cycle processes • NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment • NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment • EN ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing • EN ISO 14971: Medical devices – Application of risk management to medical devices • IEC/EN 60601-1 Medical electrical equipment – Part 1: General requirements for safety • IEC 61340-5-1: Electrostatics – Part 5-1: Protection of electronics devices from electrostatic phenomena – General Requirements  )!*





• IEC 61340-5-2: Electrostatics – Part 5-2: Protection of electronics devices from electrostatic phenomena – User guide • EN 50419: 2006 Marking of electrical and electronical equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE) • Digital Imaging and Communications in Medicine (DICOM) standard: PS 3 -2011

    SuperSonic Imagine is ISO 13485 certified. SuperSonic Imagine is ISO 14001:2015 certified.

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 Customer service representatives are available regionally to help answer your questions. Please contact your local SuperSonic Imagine sales or service representative for assistance.

= SuperSonic Imagine Les Jardins de la Duranne - Bât E & F 510, rue René Descartes 13857 Aix en Provence Cedex - France Telephone: +33 (0)442 99 24 32 Telephone: +33 (0)426 70 02 70 Fax: +33 (0)442 52 59 21 E-mail: [email protected]


  SuperSonic Imagine, Inc. 2625 Weston Road Weston, FL 33331- North America Telephone: +1(954) 660 3528 E-mail: [email protected]

 
9 %  SuperSonic Imagine Ltd., 18 Upper Walk Virginia Water  )!*





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Surrey GU25 4SN - United Kingdom Telephone: +44 (0)845 643-4516 E-mail: [email protected]

( SuperSonic Imagine GmbH Zeppelinstr. 71 – 73 81669 München - Germany Phone: +49 89 36036 - 844 Fax: + 49 89 36036 - 700 E-mail: [email protected]

 SuperSonic Imagine Suite 2304, Block D, Ocean International, DongSiHuan ZhongLu, Chaoyang District, Beijing (100025), China Phone : +86-10- 85861023/ 2951/ 2917 Fax: + 86-10-8586 2389 E-mail: [email protected]

#"  Call your SuperSonic Imagine local representative.



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#"  The SuperSonic Imagine Aixplorer® ultrasound system is intended to provide many years of service. The lifetime of the product is directly impacted by the following variables: • Hours of clinical operational use of the product • Hours of clinical non-operation use while the product is energized and in the “on” state • Environmental exposure of the product with regard to temperature, humidity and pressure • Appropriate electrical power conditions • Proper handling and moving of the product • Proper storage of the product when not in use • Proper maintenance and cleaning of the product • Quality of repairs • Quality of accessories used with the device The SuperSonic Imagine Aixplorer® ultrasound system has to be installed by an authorized SuperSonic Imagine sales or service representative. To optimize operation and maximize the life of the product, we recommend having an annual maintenance performed by a SuperSonic Imagine authorized representative. Maintenance and service contracts are available. All repairs must be conducted by a SuperSonic Imagine authorized representative. Maintenance operations as described in Chapter 9, System Care & Maintenance [429] can be performed by the user. Improper installation, repair or maintenance will void any warranties associated with the product. Please contact a SuperSonic Imagine sales or service representative for further information.  )!*







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$  Upgrades may be announced that consist of hardware or software improvements. Updated user information will accompany those system upgrades. Always verify that you are using the revision of this document appropriate for your product version. To verify the correct version of the document for your system or to obtain the latest revision, contact your SuperSonic Imagine representative or local distributor.



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