F31-Safety-Instruction

[Page 1] DIAGNOSTIC ULTRASOUND SYSTEM Instruction Manual Safety Instruction (volume 1/2) (volume 1/2) Instruction manuals consist of this manual, Power Data Book, How to Use and Measurement. Before using this system, please read this manual. MN1-5853 rev.2

[Page 2] Copyright©Hitachi Aloka Medical, Ltd. All rights reserved. Microsoft, Windows and Windows Media are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. McAfee logo and product names of McAfee are registered trademarks or trademarks of McAfee, Inc. or its subsidiaries in the United States and other countries. All brand name, product name, and system name are registered trademarks or trademarks of their respective owners. In this manual, ™ and ® are omitted. VS-FlexGrid Pro copyright©1999-2000 Videosoft Corporation. Portions of this software are based in part on the work of the Independent JPEG Group. MN1-5853 rev.2

[Page 3] This is an instruction manual for F31, a diagnostic ultrasound system. Read the manual carefully before using the system. Take special note of the items in Chapter 1, "Safety Precautions" of Safety Instruction manual. Keep this manual securely for future reference. Symbols Used in this Document The following items are important in preventing harm or injury to the operator of the equipment and the patient. There are 4 levels of harm/damage that can be caused by ignoring instructions or displays and using the equipment incorrectly: "Danger", "Warning", "Caution", and "Note". These types are indicated by the following symbols. Indicates an imminently hazardous situation which, if not avoided, will result in the death or serious injury of the operator of the equipment. Indicates a hazardous situation which, if not avoided, may result in death or serious injury. Indicates a hazardous situation which, if not avoided, may result in slight or moderate injury, or property damage. Indicates a request concerning an item that must be observed in order to prevent damage or deterioration to the equipment and also to ensure effective use. Cautions of cautions shows the following graphics. This mark means the corresponding item is "alerted". This mark means the corresponding item is "prohibited". This mark means the corresponding item is "required". MN1-5853 rev.2 3

[Page 4] About the F31 The F31 is intended to be used by doctors and other qualified personnel in fracture diagnostics and hemodynamic diagnostics. However, this equipment is not designed to be used in ophthalmic ultrasound diagnosis, as its sound intensity is not compliant with ophthalmic restrictions established by the FDA. Only physicians and other qualified personnel should operate this equipment for diagnostic purposes. Read section 1-1 of the Safety Instruction manual. 1) PRECAUTIONS Concerning the Use/Management of the F31 • Do not disassemble, repair or remodel this equipment or optional features without our consent. NOTE: Disassemble is removing the parts or options from the equipment using tools. NOTE: Remodel is installing or connecting the unspecified parts or equipment, including replacement of power cord. • Assemble of the equipment or optional accessories shall be performed by our third party certified. Please contact one of our offices listed on back cover. Assemble is installing and connecting the parts or optional accessories in the main equipment using tools. • Transporting this equipment (via automobile/ship) shall be performed by a third party certified by the manufacturer. Please contact one of our offices listed on back cover. • Please conduct routine cleaning and inspection of the equipment. Refer to Chapter 5 of the Safety Instruction for details. • Ensure that the output level of the scan conforms to the required duration of diagnosis. • If any malfunction or abnormality is discovered during operation of the equipment, remove the probe from the patient immediately and discontinue use. If any abnormality is observed in the patient, provide proper care as quickly as possible. Refer to Chapter 4 of the Safety Instructions for more information on dealing with the equipment appropriately. If the malfunction is not listed in Chapter 4 of the Safety Instructions, contact one of our offices listed on back cover. 2) PRECAUTIONS for the F31 Installation This equipment is a medical electrical equipment that intended for use in hospitals, research facilities. The equipment should be installed in accordance with the following guidelines. • Install in accordance with Chapter 3 of the Safety Instructions. • Install in an environment that conforms to the operating environments indicated in section 2-2-1 of the Safety Instructions. • Install in an environment that ensures electromagnetic compatibility, in accordance with section 1-2-6 of the Safety Instructions, "Guideline for Electromagnetic Compatibility", and Item 1-3, "Electromagnetic compatibility". 4 MN1-5853 rev.2

[Page 5] NOTE: The electromagnetic compatibility (EMC) is ability of device to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment. Classification of F31 • Protection against electric shock (ME equipment): class I • ME equipment • Protection against electric shock (Applied parts): type BF Applied Parts – Probe/scanner applied parts and parts treated as applied parts: Refer to the following diagram (Probe/Scanner Pattern Diagram) and table. B C A connector connector C A Figure:Probe/Scanner Pattern Diagram Above illustrates a surface/intraoperative probe. Below shows a coelomic probe. Applicable part Parts treated as applied of body Applied part parts B - C length Surface of body Ultrasonic irradiation area (D) A to B 100 cm Intraoperative Ultrasonic irradiation area (D) A to B 20 cm Endocavity A to C A to C - – ECG The 2-meter length of the ECG cable extending from the ECG electrodes is treated as applied part (see diagram below). 2 meters ECG electrodes connector ECG patient lead • Protection against electric shock (Defibrillation-proof applied parts): Not suitable • Protection against harmful ingress of water or particulate matter – equipment: IPX0 (Ordinary equipment) – Probe applied part: IPX7 (Watertight equipment) • Suitability for use in an oxygen rich environment: Not suitable • Method (s) of sterilization: Not suitable for sterilization/disinfection with medicinal solution, gas or radiation. • Mode of operation: Continuous operation MN1-5853 rev.2 5

[Page 6] Terms used in the book Example Method Intended Press ENTER . Press the specified switch on the operation panel Switches on the ( ENTER in the example). operation panel (including the Rotary Encoder ) Turn Rotary Encoder . Rotate a switch such as Rotary Encoder to the • Rotary Encoder left and right. • Multi Gain To the left: counterclockwise direction • B Gain To the right: clockwise direction • DEPTH/ZOOM Select Preset key. Press the specified key ( Preset in the example) Keyboard on the keyboard. 1 Using trackball, move the pointer on the • Buttons or items on Select Set-Up . button ( Set-Up in the example). the screen 2 Press ENTER . • Thumbnails • Toggle buttons On: Off: • Radio buttons On: Off: Preset ( Set-Up > Menus in the bracket are shown hierarchy of the Tree View. (Application) > 1 Press PRESET key. Menu-Function ) 2 Move the pointer to the Set-Up and press ENTER . 3 Move the pointer to the preset ( (Application) in the example) and press ENTER . Repeat until a specified preset is displayed. Warning regarding the software used for this instrument Regarding the software installed in this instrument, the following is prohibited. 1) Reselling, assigning, or transferring the software itself 2) Reverse engineering, reverse compiling, or reverse assembling 3) Modification, alteration or translation 4) Creating copies or duplicates 5) Leasing to third parties 6 MN1-5853 rev.2

[Page 7] License Agreement Microsoft Software License Terms Notes on Microsoft Software License Terms This ultrasound diagnostic system uses Windows operating system, a product of Microsoft Corporation in the United States. Details regarding Windows license terms are described in the following pages. Please read these terms before using the ultrasound diagnostic system. Terminology that appears in the license terms is defined as follows; • "This device" refers to the ultrasound diagnostic system. • "This software" refers to Windows. • "[OEM]" refers to Hitachi Aloka Medical Corporation. • "Other software" refers to the ultrasound diagnostic system software and other related software. For the Microsoft Software License Terms, the following restrictions are given priority to ensure safe and stable operation of the ultrasound diagnostic system. Confirm all of the following; • Only Windows functions, updates, add-on software, Internet-based services, and support services authorized by Hitachi Aloka Medical Corporation can be used. • Internet-related services cannot be used except for Sentinel customer service. • Terminal services, file services, print services, Internet information services, and Internet connection sharing and telephony services cannot be used. • The remote boot feature cannot be used. • Remote access technologies such as Remote Desktop cannot be used. • Windows Update Agent (Software Update Services) cannot be used. • Backup copies of Windows cannot be made. For inquiries to Hitachi Aloka Medical Corporation regarding these license terms, please contact service support. MN1-5853 rev.2 7

[Page 8] Windows XP Embedded and Windows Embedded Standard Runtime These license terms are an agreement between you and [OEM]. Please read them. They apply to the software included on this device. The software also includes any separate media on which you received the software. The software on this device includes software licensed from Microsoft Corporation or its affiliate. The terms also apply to any Microsoft. • Updates • Supplements • Internet-based services • Support services for this software, unless other terms accompany those items. If so, those terms apply. If you obtain updates or supplements directly from Microsoft, then Microsoft, and not [OEM], licenses those to you. As described below, using some features also operates as your consent to the transmission of certain standard computer information for Internet-based services. By using the software, you accept these terms. If you do not accept them, do not use or copy the software. Instead, contact [OEM] to determine its return policy for a refund or credit. If you comply with these license terms, you have the rights below. 1) Use Rights. You may use the software on the device with which you acquired the software. 2) Additional Licensing Requirements and/or Use Rights. a) Specific Use. [OEM] designed this device for a specific use. You may only use the software for that use. b) Other Software. You may use other programs with the software as long as the other programs. – Directly support the manufacturer’s specific use for the device. – Provide system utilities, resource management, or anti-virus or similar protection. Software that provides consumer or business tasks or processes may not be run on the device. This includes email, word processing, spreadsheet, database, scheduling and personal finance software. The device may use terminal services protocols to access such software running on a server. c) Device Connections. – You may use terminal services protocols to connect the device to another device run- ning business task or processes software such as email, word processing, scheduling or spreadsheets. – You may allow up to ten other devices to access the software to use. 8 MN1-5853 rev.2

[Page 9] • File Services • Print Services • Internet Information Services • Internet Connection Sharing and Telephony Services The ten connection limit applies to devices that access the software indirectly through “multiplexing” or other software or hardware that pools connections. You may use unlimited inbound connections at any time via TCP/IP. 3) Scope of License. The software is licensed, not sold. This agreement only gives you some rights to use the software. [OEM] and Microsoft reserve all other rights. Unless applicable law gives you more rights despite this limitation, you may use the software only as expressly permitted in this agreement. In doing so, you must comply with any technical limitations in the software that allow you to use it only in certain ways. For more information, see the software documentation or contact [OEM]. Except and only to the extent permitted by applicable law despite these limitations, you may not; • Work around any technical limitations in the software. • Reverse engineer, decompile or disassemble the software. • Make more copies of the software than specified in this agreement. • Publish the software for others to copy. • Rent, lease or lend the software. • Use the software for commercial software hosting services. Except as expressly provided in this agreement, rights to access the software on this device do not give you any right to implement Microsoft patents or other Microsoft intellectual property in software or devices that access this device. You may use remote access technologies in the software such as Remote Desktop to access the software remotely from another device. You are responsible for obtaining any licenses required for use of these protocols to access other software. • Remote Boot Feature. If the [OEM] enabled the device Remote Boot feature of the software, you may. i) use the Remote Boot Installation Service (RBIS) tool only to install one copy of the software on your server and to deploy the software on licensed devices as part of the Remote Boot process. ii) use the Remote Boot Installation Service only for deployment of the software to devices as part of the Remote Boot process. iii) download the software to licensed devices and use it on them. For more information, please refer to the device documentation or contact [OEM]. • Internet-Based Services. Microsoft provides Internet-based services with the software. Microsoft may change or cancel them at any time. MN1-5853 rev.2 9

[Page 10] i) Consent for Internet-Based Services. The software features described below connect to Microsoft or service provider computer systems over the Internet. In some cases, you will not receive a separate notice when they connect. You may switch off these features or not use them. For more information about these features, visit http://www.microsoft.com/windowsxp/downloads/updates/sp2/docs/privacy.mspx. By using these features, you consent to the transmission of this information. Microsoft does not use the information to identify or contact you. ii) Computer Information. The following features use Internet protocols, which send to the appropriate systems computer information, such as your Internet protocol address, the type of operating system, browser and name and version of the software you are using, and the language code of the device where you installed the software. Microsoft uses this information to make the Internet-based services available to you. • Web Content Features. Features in the software can retrieve related content from Microsoft and provide it to you. To provide the content, these features send to Microsoft the type of operating system, name and version of the software you are using, type of browser and language code of the device where the software was installed. Examples of these features are clip art, templates, online training, online assistance and Appshelp. These features only operate when you activate them. You may choose to switch them off or not use them. • Digital Certificates. The software uses digital certificates. These digital certificates confirm the identity of Internet users sending X.509 standard encrypted information. The software retrieves certificates and updates certificate revocation lists. These security features operate only when you use the Internet. • Auto Root Update. The Auto Root Update feature updates the list of trusted certificate authorities. You can switch off the Auto Root Update feature. • Windows Media Player. When you use Windows Media Player, it checks with Microsoft for • Compatible online music services in your region • New versions of the player • Codecs if your device does not have the correct ones for playing content. You can switch off this feature. For more information, go to: http://microsoft.com/windows/windowsmedia/mp10/privacy.aspx. 10 MN1-5853 rev.2

[Page 11] • Windows Media Digital Rights Management. Content owners use Windows Media digital rights management technology (WMDRM) to protect their intellectual property, including copyrights. This software and third party software use WMDRM to play and copy WMDRM-protected content. If the software fails to protect the content, content owners may ask Microsoft to revoke the software’s ability to use WMDRM to play or copy protected content. Revocation does not affect other content. When you download licenses for protected content, you agree that Microsoft may include a revocation list with the licenses. Content owners may require you to upgrade WMDRM to access their content. Microsoft software that includes WMDRM will ask for your consent prior to the upgrade. If you decline an upgrade, you will not be able to access content that requires the upgrade. You may switch off WMDRM features that access the Internet. When these features are off, you can still play content for which you have a valid license. iii) Misuse of Internet-based Services. You may not use these services in any way that could harm them or impair anyone else’s use of them. You may not use the services to try to gain unauthorized access to any service, data, account or network by any means. 4) Windows Update Agent (also known as Software Update Services). The software on the device includes Windows Update Agent (“WUA”) functionality that may enable your device to connect to and access updates (“Windows Updates”) from a server installed with the required server component. Without limiting any other disclaimer in this Micrososoft Software License Terms or any EULA accompanying a Windows Update, you acknowledge and agree that no warranty is provided by MS, Microsoft Corporation or their affiliates with respect to any Windows Update that you install or attempt to install on your device. 5) Product Support. Contact [OEM] for support options. Refer to the support number provided with the device. 6) Backup Copy. You may make one backup copy of the software. You may use it only to reinstall the software on the device. 7) Proof Of License. If you acquired the software on the device, or on a disc or other media, a genuine Certificate of Authenticity label with a genuine copy of the software identifies licensed software. To be valid, this label must be affixed to the device, or included on or in [OEM]’s software packaging. If you receive the label separately, it is not valid. You should keep the label on the device or packaging to prove that you are licensed to use the software. To identify genuine Microsoft software, see http://www.howtotell.com. 8) Transfer to a Third Party. You may transfer the software only with the device, the Certificate of Authenticity label, and these license terms directly to a third party. Before the transfer, that party must agree that these license terms apply to the transfer and use of the software. You may not retain any copies of the software including the backup copy. 9) Not Fault Tolerant. The software is not fault tolerant. [OEM] installed the software on the device and is responsible for how it operates on the device. MN1-5853 rev.2 11

[Page 12] 10) Restricted Use. The Microsoft software was designed for systems that do not require fail-safe performance. You may not use the Microsoft software in any device or system in which a malfunction of the software would result in foreseeable risk of injury or death to any person. This includes operation of nuclear facilities, aircraft navigation or communication systems and air traffic control. 11) No Warranties for the Software. The software is provided “as is”. You bear all risks of using it. Microsoft gives no express warranties, guarantees or conditions. Any warranties you receive regarding the device or the software do not originate from, and are not binding on, Microsoft or its affiliates. When allowed by your local laws, [OEM] and Microsoft exclude implied warranties of merchantability, fitness for a particular purpose and non-infringement. 12) Liability Limitations. You can recover from Microsoft and its affiliates only direct damages up to two hundred fifty U.S. Dollars (U.S. $250.00). You cannot recover any other damages, including consequential, lost profits, special, indirect or incidental damages. This limitation applies to; • Anything related to the software, services, content (including code) on third party internet sites, or third party programs. • Claims for breach of contract, breach of warranty, guarantee or condition, strict liability, negligence, or other tort to the extent permitted by applicable law. It also applies even if Microsoft should have been aware of the possibility of the damages. The above limitation may not apply to you because your country may not allow the exclusion or limitation of incidental, consequential or other damages. 13) Export Restrictions. The software is subject to United States export laws and regulations. You must comply with all domestic and international export laws and regulations that apply to the software. These laws include restrictions on destinations, end users and end use. For additional information, see www.microsoft.com/exporting. 12 MN1-5853 rev.2

[Page 13] McAfee Embedded Control The terms of this license agreement constitute the entire agreement between you and Hitachi Aloka Medical, Ltd. Please carefully read through the terms of the license agreement listed below. These license terms apply to the software included on this system. They also apply when the software has been installed on other media. This system includes software provided under a license agreement with McAfee, Inc. and its subsidiaries (hereafter referred to as "McAfee"). These license terms also apply to any McAfee • Updates • Supplements • Support services for this software, except where these are accompanied by other terms, in which case those terms apply. By using this software, you agree to accept these terms. If you do not accept these terms, please do not use the software. Instead, contact Hitachi Aloka Medical, Ltd. to determine their return policy for a refund or credit. If you comply with these license terms, you are entitled to the rights listed below Software License Agreement Hitachi Aloka Medical, Ltd. (hereafter referred to as "we" or "us") grants you permission to use the software (the software program and its related documentation are hereafter collectively referred to as "the software") provided for under this agreement subject to the following terms. The use of this software is deemed as acceptance of all of the terms of this license agreement. If you do not accept them, please do not use the software. 1) Intellectual Property All copyright and other intellectual property rights inherent to the software belongs to the software developer and the software is protected by the copyright laws, and any other applicable rules and regulations, of the country in which it is used. You must therefore handle the software in the same manner as any other copyrighted work. 2) Granted Usage Rights a) The user is granted a non-exclusive right to use the software subject to the terms of this agreement. b) This software has been designed for a specific purpose. You may use it only for that purpose. MN1-5853 rev.2 13

[Page 14] 3) Scope of License This software is licensed, not sold. This agreement only gives you limited rights to use the software. We and the developer of this software reserve all other rights. You must comply with any technical limitations in the software that only allow you to use it in certain ways. Except and only to the extent otherwise permitted by applicable laws, you may not; a) Work around any technical limitations in the software. b) Reverse engineer, decompile or disassemble the software. c) Make copies of the software. d) Publish the software for others to copy. e) Rent, lease or lend the software. 4) Limitations a) Unless expressly permitted by this license agreement, you may not copy or alter the software, in part or in whole. b) You may not remove copyright notices or notices of other rights from the software or related documentation. c) This software is not designed for life-sustaining purposes or systems that involve a high level of risk and must therefore not be used in nuclear facilities, aircraft control or air traffic control systems, life supporting systems, weapons or similar systems. 5) Limited Warranty a) We and the developer of this software (hereafter referred to as "we" or "us") assume no liability whatsoever to any person or entity for damages or losses allegedly caused by the use of the software or the failure to use the software, including business interruptions, data loss, financial loss or loss of anticipated profit, loss of business information, legal expenses, technicians’ fees, court expenses or other financial damages that have been incurred as a result of the use of the software, even if we had been directly or indirectly advised of the possibility of such damages beforehand. This software is provided "as is" and we make no claims with regard to its fitness for any purpose. The software may not be free from errors and we do not guarantee uninterrupted operation. By using this software, you acknowledge that you are aware of and accept the fact that file changes potentially caused by a computer virus infection may lead to unforeseen changes in these files as a result of the processes used to remove said viral infection. b) We provide no warranty with respect to the software except in the cases stated in paragraph c) below. c) If we produce a bug fix for the software within a period of less than six months after a customer’s initial purchase of the software , we will provide said customers with the revised software, or software intended to rectify the bug (such software is hereafter referred to as "revised software") or provide information regarding such revisions. However, the determination of the need for providing revised software or information regarding such revised software, as well as when and how it is provided, is entirely at our discretion. The revised software provided to customers is regarded as part of this software. The above exception is the sole warranty that we provide for the recording media of the software. 14 MN1-5853 rev.2

[Page 15] 6) Liability Limitations Our and the software developer's (hereafter referred to as "we," "us" or "our") liability and the customer's avenues of recourse are described below. a) We accept no liability whatsoever for damages incurred by the customer in the use of the software. However, this may not be the case in the event that liability is found to be attributable to us. b) However, even in the event that we are found to be liable for damages due to the above paragraph a) or applicable laws and/or regulations, our liability to you is limited to no more than half of the price that you paid for this software within the 12 months prior to the action or event giving rise to liability and we accept no liability for damages (normal damages) normally arising from failure, negligence or illegal activities deemed to exceed commonly accepted norms and/or special or indirect damages of any kind arising from data loss, loss of business opportunities and/or loss of revenue, even if we had been advised of the possibility of such damages beforehand. 7) Other Details a) You must comply with all laws and regulations of the country of export and all applicable international laws and regulations when exporting the software (including related documentation) from the country of export. This software includes software created in the United States and must therefore comply with the Export Administration Regulations (EAR) of the United States. b) This license agreement is proof of the right to use this software and must therefore be retained by the customer. MN1-5853 rev.2 15

[Page 16] Contents 1-1 Purpose of Use 1-1 1-2 Precautions for Use 1-2 1-2-1 Warnings and Safety Notice 1-3 1-2-2 Labels 1-6 1-2-3 Precautions concerning acoustic power 1-11 1-2-4 Precautions for Use in Conjunction with Drugs 1-12 1-2-5 Precautions for Use in Conjunction with Other Medical Devices 1-13 1-2-6 Guideline for Electromagnetic Compatibility 1-14 1-3 Electromagnetic compatibility 1-16 1-3-1 Guidance and manufacturer’s declaration - electromagnetic emissions 1-16 1-3-2 Essential performance 1-17 1-3-3 Guidance and manufacturer’s declaration - electromagnetic immunity 1-18 1-3-4 Guidance and manufacturer’s declaration - electromagnetic immunity 1-19 1-3-5 Recommended separation distances between portable and mobile RF communications equipment and the F31 1-20 1-4 Electrostatic Discharge (ESD) Guidelines 1-21 2 Specifications and Parts Name 2-1 Principle of Operation 2-1 2-2 Specifications 2-3 2-2-1 Environmental Conditions 2-6 2-2-2 Power Requirements 2-6 2-2-3 Classification of F31 2-7 2-3 Parts Names 2-8 2-3-1 Exterior 2-8 2-3-2 Operation Panel 2-11 3 Preparation for Use 3-1 Installing the equipment 3-1 3-2 Connecting Peripheral Instruments 3-3 3-2-1 Connecting/Removing a Probe 3-4 3-2-2 Connect the Physiological Signal Connector 3-6 3-2-3 Connecting with Other Instruments 3-8 3-3 Moving the equipment 3-11 3-3-1 Isolate from the supply main 3-11 3-3-2 Moving equipment 3-12 16 MN1-5853 rev.2

[Page 17] 3-4 Storing the Instrument 3-15 3-5 Inspection Before Using 3-16 3-5-1 External Inspection 3-16 3-5-2 Operation Check 3-17 3-5-3 Modifying the Date and Time 3-18 3-5-4 Specifying the Hospital Name 3-19 3-5-5 Volume Control 3-19 3-6 Screen Display 3-20 3-6-1 Character Display 3-20 3-6-2 Graphic Display 3-22 3-7 Adjusting the Operation Panel 3-24 3-7-1 Adjusting the Operation Panel 3-24 3-7-2 Adjust the Orientation of the Operation Panel 3-25 3-7-3 Adjusting the Brightness of the Operation Panel Switch 3-25 3-7-4 Changing the Labeling of the Operation Panel Switches 3-26 3-7-5 Changing the color of the trackball 3-27 3-8 Adjusting the Monitor 3-28 3-8-1 Adjusting the Orientation of the Monitor 3-28 3-8-2 Adjusting the Brightness of the Monitor 3-29 3-9 Viewing the instruction manual on the CD-ROM 3-30 3-10 The Flow of the preparation to the study 3-31 3-10-1 Operating Mode 3-31 3-10-2 Freezing image/Unfreezing image 3-32 3-10-3 Measuring on a ultrasound image 3-32 3-10-4 Printing images or Storing images 3-32 4 Troubleshooting 4-1 Messages 4-1 4-2 Dialog messages 4-2 4-3 Assistance messages 4-9 4-4 Other problems 4-11 4-4-1 Image Display and Image Degradation 4-11 5 Maintenance 5-1 After Using the Instrument 5-1 5-1-1 State of the Instrument and Accessories 5-2 5-2 Cleaning 5-3 5-2-1 Clean the Instrument 5-4 5-2-2 Cleaning the Air Filter 5-5 5-2-3 Cleaning the Trackball 5-6 5-2-4 Cleaning Endo-cavity Probe Holder(Horizontal) 5-7 MN1-5853 rev.2 17

[Page 18] 5-3 Maintenance 5-9 5-3-1 Daily check: For Using the Instrument for a Long Period 5-10 5-3-2 Checking the Measurement Accuracy 5-11 5-3-3 Safety Inspection 5-18 6 Accessories and Options 6-1 Instrument and Accessories 6-1 6-2 Options 6-1 6-2-1 Recording Devices 6-2 6-2-2 Functional Expansion Units 6-2 6-2-3 Other Accessories 6-3 6-2-4 Softwares 6-3 7 Probes 7-1 Caution in the Handling of Probes 7-1 7-1-1 Caution about Handling of Probes 7-1 7-1-2 Cautions about Cleaning and Storage 7-3 7-2 Probe specifications 7-5 7-2-1 Convex Sector Probes 7-6 7-2-2 Linear Probes 7-8 7-2-3 Phased Array Sector Probes 7-9 7-3 Clinical Measurement Range 7-10 8 Acoustic Output Safety Information 8-1 Acoustic output index 8-1 8-2 Interaction between ultrasound and tissue 8-3 8-2-1 Possible Biological Effects 8-4 8-3 Derivation and Meaning of MI/TI 8-6 8-3-1 Mechanical Index (MI) 8-7 8-3-2 Thermal Index (TI) 8-7 8-4 Setting condition influencing device output 8-9 8-5 Recommendation on ALARA principle 8-10 8-6 Default Setting 8-11 8-7 Acoustic output Limits 8-11 8-8 Measurement uncertainties 8-12 8-8-1 Protocol for calculating the measurement uncertainties 8-12 8-8-2 Results of measurement uncertainties 8-15 8-9 References 8-22 18 MN1-5853 rev.2

[Page 19] 1-1 Purpose of Use 1-1 Purpose of Use In the diagnostic ultrasound system, ultrasound images are produced as follows; Ultrasound wave pulses released from the transducer are reflected from the internal body system. Reflected waves are transmitted back to the transducer, and ultrasound images are produced with the reflected image on the monitor. You can distinguish internal body systems because the acoustic impedances vary among the internal organs. Ultrasound images are used for various diagnoses of the internal body system. This F31 is intended to be used by doctors and other qualified persons for performing slice diagnoses and blood circulation diagnoses in the following parts of the human body. • Thorax • Abdomen • Perineum and pelvis • Lower limbs • Back • Upper limbs • Head • Neck Do not use it for any applications other than those stated above. Do not use this equipment for performing ultrasound diagnosis of the eyes. The acoustic power from this equipment exceeds the upper ophthalmological limits indicated in the U.S. FDA standards. Do not use it for any application that is not covered in the instruction manual of the probe. There is a risk of injuries or burns to the patient or oprator. There is a risk of electrical shock, breakdown or other accidents. MN1-5853 rev.2 1-1

[Page 20] 1-2 Precautions for Use 1-2 Precautions for Use Before using this device, please read this manual. Be especially sure to read "1. Safety Precautions". Keep this manual securely for future reference. The following items are important in preventing harm or injury to equipment operator or patient. There are four levels of harm/damage that can be caused by ignoring instructions/displays or using the equipment incorrectly: "Danger," "Warning," "Caution," and "Note." Indicates an imminently hazardous situation that will result in the death of or serious injury to the equipment operator. Indicates a hazardous situation that could result in death or serious injury. Indicates a hazardous situation that may result in slight or moderate injury, or property damage. Indicates a request concerning an item that must be observed in order to prevent damage or deterioration to the equipment and also to ensure effective use. Cautions use the following graphics. This mark means the corresponding item is "alerted". This mark means the corresponding item is "prohibited". This mark means the corresponding item is "required". 1-2 MN1-5853 rev.2