Qisda T3300 Diagnostic Ultrasound System User Manual Diagnostic Ultrasound System Victoria UM en

Qisda Corporation Diagnostic Ultrasound System Diagnostic Ultrasound System Victoria UM en

Users Manual

T3300Ultrasound SystemBasic Operating Instructions
T3300 Diagnostic Ultrasound System |1| B00601-010 4/10/17Table of ContentsChapter 1: Read This First ..........................................................................................................................1Intended Audience................................................................................................................................. 2Intended Use ......................................................................................................................................... 2Warnings................................................................................................................................................ 3WEEE .................................................................................................................................................... 3Discarding the Tablet and Batteries....................................................................................................... 3Equipment List....................................................................................................................................... 4Conventions........................................................................................................................................... 4System Warranty ................................................................................................................................... 5Chapter 2: Safety Information .....................................................................................................................6Symbols................................................................................................................................................. 8System Label Icons.......................................................................................................................9System Button...............................................................................................................................9Shipping Label Icons...................................................................................................................10Electrical Safety................................................................................................................................... 10Battery Usage/Disposal...............................................................................................................11Electrical Fast Transients (EFT)..................................................................................................11Electromagnetic Interference (EMI).............................................................................................12Surges to AC Power Mains .........................................................................................................15Mechanical Safety ............................................................................................................................... 15Equipment Protection .......................................................................................................................... 15RF Safety............................................................................................................................................. 16Biological Safety .................................................................................................................................. 16Heating........................................................................................................................................17Cavitation ....................................................................................................................................17Safe Scanning Guideline.............................................................................................................17Operator Safety ................................................................................................................................... 18Infection Control ..........................................................................................................................18Disposable Drape........................................................................................................................18Waterproof and Dustproof Ratings ...................................................................................................... 19Understanding the MI/TI Display ......................................................................................................... 19TI .................................................................................................................................................21MI ................................................................................................................................................21Display and Report in Different Modes........................................................................................22Operator Control Features ..........................................................................................................22Transducer Surface Temperature Rise ............................................................................................... 22Chapter 3: Overview..................................................................................................................................23System Capabilities ............................................................................................................................. 24Imaging........................................................................................................................................24Transducer Types .......................................................................................................................24Measurements.............................................................................................................................24Calculations.................................................................................................................................24Image Acquisition and Review ....................................................................................................24Connectivity.................................................................................................................................25System Overview................................................................................................................................. 26Front and Side Views ..................................................................................................................26Rear and Top/Bottom Views .......................................................................................................28Transducer Overview........................................................................................................................... 29Clinical Applications and Transducers ........................................................................................29Indications for Use and Supporting Transducers................................................................................. 29Chapter 4: Preparing the System..............................................................................................................31Inserting a microSD Card .................................................................................................................... 32Using the Stand ................................................................................................................................... 33Charging the System ........................................................................................................................... 33Installing the Transducer Holder.......................................................................................................... 34Connecting the Transducer ................................................................................................................. 35Removing the Transducer ................................................................................................................... 36Using the System On The Go.............................................................................................................. 37
T3300 Diagnostic Ultrasound System |2| B00601-010 4/10/17Wall-mounting Your Tablet .................................................................................................................. 38Outputting the System Display to an HDMI-Enabled TV or Monitor.................................................... 39Chapter 5: Using the System ....................................................................................................................40Turning On/Off the System.................................................................................................................. 41Launching the Main Screen................................................................................................................. 41Setting the System Time and Date...................................................................................................... 42Controlling the System......................................................................................................................... 43Gestures for Controlling the Real-time/Frozen Imaging Screens................................................44Gestures for Controlling the Real-time Imaging Screen..............................................................44Gestures for Controlling the Frozen Imaging Screen..................................................................45Setting the System Language.............................................................................................................. 45Identifying the Main Screen Layout ..................................................................................................... 45System Menu Screen..................................................................................................................45Imaging Screen (Real-time) ........................................................................................................46Imaging Screen (Frozen).............................................................................................................48Quick Setup.................................................................................................................................50Virtual Keyboard..........................................................................................................................51Scan Properties Display..............................................................................................................51Switching the Control Panel Pages ..................................................................................................... 52Managing the System Power............................................................................................................... 52Battery Status Icons ....................................................................................................................53Sleep Mode .................................................................................................................................53Managing Disk Space.......................................................................................................................... 53Network Configuration ......................................................................................................................... 54Connecting the System to the Network by Ethernet....................................................................54Connecting the System to the Wireless Network ........................................................................54Connecting the System to a Bluetooth Device............................................................................55Unpair a Bluetooth Device...........................................................................................................55DICOM Configuration .......................................................................................................................... 55Adding Servers............................................................................................................................55Local Host ...................................................................................................................................56Managing Outgoing Queue .........................................................................................................56Casting the System Screen to an External Display ............................................................................. 57Chapter 6: Performing an Exam................................................................................................................58Starting a New Exam........................................................................................................................... 59Adding a New Patient .......................................................................................................................... 59Updating Patient Information.......................................................................................................59Loading a Worklist ............................................................................................................................... 60Selecting a Preset................................................................................................................................ 60Customizing a Preset ..................................................................................................................61Modifying a Preset.......................................................................................................................61Managing Presets .......................................................................................................................61Exporting and Importing Customized Presets.............................................................................61Setting the Transducer Orientation...................................................................................................... 62Selecting/Switching a Scan Mode ....................................................................................................... 62Adjusting the Displayed Image ............................................................................................................ 62Enlarging an Area of the Image...................................................................................................63Splitting the Imaging Screen .......................................................................................................63Freezing an Image............................................................................................................................... 65Adding Annotations.............................................................................................................................. 65Arrow...........................................................................................................................................66Annot...........................................................................................................................................66Label............................................................................................................................................66Body Mark ...................................................................................................................................67Adding Measurements......................................................................................................................... 68Measuring in B/Color/Power Modes............................................................................................69Measuring in M-Mode..................................................................................................................70Measuring in Spectral Doppler Mode ..........................................................................................71
T3300 Diagnostic Ultrasound System |3| B00601-010 4/10/17Saving and Printing the Image............................................................................................................. 72Saving an Image Loop ................................................................................................................72Saving an Image .........................................................................................................................72Printing an Image ........................................................................................................................72Reviewing the Image ........................................................................................................................... 72Performing Multiple Selections....................................................................................................73Comparing Images......................................................................................................................74Generating a Report....................................................................................................................74Exporting the Exam ............................................................................................................................. 75Managing the Exam History................................................................................................................. 75Resuming an Exam.....................................................................................................................76Starting a New Exam...................................................................................................................76Finishing Exams..........................................................................................................................76Deleting Exams ...........................................................................................................................76Exporting Exams .........................................................................................................................77Importing Exams .........................................................................................................................77Ending the Exam ................................................................................................................................. 77Chapter 7: Using Image Controls..............................................................................................................78B-Mode Image Controls....................................................................................................................... 79Overview .....................................................................................................................................79Adjusting Gain.............................................................................................................................79Adjusting Frequency....................................................................................................................79Adjusting Time Gain Compensation (TGC).................................................................................79Adjusting the Scan Depth............................................................................................................80Adjusting the Focus Depth, Focal Zone and Focal span.............................................................80Adjusting Dynamic Range...........................................................................................................80Using Tissue Harmonic Imaging (THI) ........................................................................................80Adjusting Persistence..................................................................................................................80Adjusting Sharpness and Smoothing ..........................................................................................80Adjusting Gray Map.....................................................................................................................80Adjusting Chroma Map................................................................................................................80Adjusting Steer Angle..................................................................................................................80Adjusting the Sector Width and Position .....................................................................................81Adjusting Power ..........................................................................................................................81Using Trapezoidal Imaging..........................................................................................................81Adjusting Density.........................................................................................................................81Using Compound Imaging...........................................................................................................81Using ENV (Enhanced Needle Visualization)..............................................................................81Color/Power Mode Image Controls...................................................................................................... 82Overview .....................................................................................................................................82Adjusting Pulse Repetition Frequency (PRF)..............................................................................83Inverting the Color Display ..........................................................................................................83Using Directional Power..............................................................................................................83Selecting a Color Map.................................................................................................................83Adjusting Wall Filter.....................................................................................................................83Applying the Smoothing Filter .....................................................................................................83Adjusting the Color Priority..........................................................................................................83M-Mode Image Controls ...................................................................................................................... 83Overview .....................................................................................................................................83Using Steer M..............................................................................................................................84Adjusting Sweep Speed ..............................................................................................................84Selecting M Process....................................................................................................................84Inverting the M-Mode Trace Display ...........................................................................................84Spectral Doppler Mode Image Controls............................................................................................... 85Overview .....................................................................................................................................85Adjusting Baseline.......................................................................................................................86Adjusting Sample Volume (SV) Size...........................................................................................86Adjusting Correction Angle..........................................................................................................86Updating the 2D Display..............................................................................................................86Chapter 8: System Customization.............................................................................................................87
T3300 Diagnostic Ultrasound System |4| B00601-010 4/10/17Customizing Your System ................................................................................................................... 88General........................................................................................................................................88Preset..........................................................................................................................................88Patient .........................................................................................................................................88Exam ...........................................................................................................................................88Workflow......................................................................................................................................88Imaging........................................................................................................................................89Annotation ...................................................................................................................................89BDMK (Body Mark) .....................................................................................................................89Measurement ..............................................................................................................................90Report..........................................................................................................................................90DICOM ........................................................................................................................................90Networking ..................................................................................................................................90Print.............................................................................................................................................90Servicing your system.......................................................................................................................... 90Reinstalling Software...................................................................................................................91Checking the Software Version ...................................................................................................91Checking the Tablet’s Serial Number..........................................................................................91Checking the License Status.......................................................................................................91Resetting System Settings ..........................................................................................................91Backing Up System Settings and Patient Data ...........................................................................92Restoring System Settings and Patient Data ..............................................................................92Resetting Your System................................................................................................................92Chapter 9: Transducer and System Maintenance.....................................................................................93Transducer Maintenance..................................................................................................................... 94Transducer Storage............................................................................................................................. 94Storage for Transport ..................................................................................................................94Daily and Long-Term Storage .....................................................................................................94Transducer Care.................................................................................................................................. 95Transducer Care and Operator Safety ........................................................................................95Inspecting the Transducer ................................................................................................................... 96Transducer Care Method..................................................................................................................... 97Transducer and Cable Cleaning.......................................................................................................... 97Cleaning Instructions...................................................................................................................97Ultrasound Transmission Gels............................................................................................................. 98Compatible Disinfectants and Cleaning Solutions............................................................................... 99System Maintenance ........................................................................................................................... 99Inspecting the System.................................................................................................................99Cleaning the System ...................................................................................................................99Chapter 10: Troubleshooting...................................................................................................................103Chapter 11: Appendices..........................................................................................................................107Appendix A: Specifications ................................................................................................................ 108System ......................................................................................................................................108Transducer ................................................................................................................................109Adapter......................................................................................................................................110Battery.......................................................................................................................................110Appendix B: Connectivity and Security.............................................................................................. 112Introduction................................................................................................................................112Specifications ............................................................................................................................112Appendix C: System Acoustic Output Default Tables........................................................................ 115C62B Transducer ......................................................................................................................115L154BH Transducer ..................................................................................................................117P42B6 Transducer ....................................................................................................................118Appendix D: Acoustic Output Reporting Tables for Track 3 .............................................................. 119Definition of Terms Used in Acoustic Output Tables.................................................................119Acoustic Output Tables for T3300 Transducers........................................................................121Appendix E: FCC Statement.............................................................................................................. 155Federal Communications Commission (FCC) Statement .........................................................155
T3300 Diagnostic Ultrasound System |1| B00601-010 4/10/17CHAPTER1Read This FirstThe T3300 Diagnostic Ultrasound System (hereinafter called “system”) isan easy-to-use, portable ultrasound imaging instrument intended for useby a qualified operator for ultrasound evaluation and clinical analysis.The Basic Operating Instructions provides important procedures andinformation on how to operate the system and service the systemcorrectly and safely. Before attempting to operate the system, read thisBasic Operating Instructions and strictly observe all warnings andcautions. Pay extra attention to the information from "Chapter 2 SafetyInformation".CopyrightCopyright 2017 BenQ Medical Technology. All rights reserved. No part ofthis publication may be reproduced, transmitted, transcribed, stored in aretrieval system or translated into any language or computer language, inany form or by any means, electronic, mechanical, magnetic, optical,chemical, manual or otherwise, without the prior written permission ofBenQ Medical Technology.All other logos, products, or company names mentioned in this BasicOperating Instructions may be the registered trademarks or copyrights oftheir respective companies, and are used for informational purposes only.DisclaimerBenQ Medical Technology makes no representations or warranties, eitherexpressed or implied, with respect to the contents hereof and specificallydisclaims any warranties, merchantability or fitness for any particularpurpose. Further, BenQ Medical Technology reserves the right to revisethis publication and to make changes from time to time in the contentshereof without obligation of BenQ Medical Technology to notify anyperson of such revision or changes.This Basic Operating Instructions aims to provide the most updated andaccurate information to customers, and thus all contents may be modifiedfrom time to time without prior notice. Please visit http://BenQMedicalTech.com for the latest version of this operating instructions.
Read This FirstT3300 Diagnostic Ultrasound System |2| B00601-010 4/10/17Contact InformationPharma Company: BenQ Medical Technology CorporationAddress: 7th floor, No. 46, Zhou-Z Street, Nei-Hu, Taipei 114, TaiwanManufacturer: Qisda CorporationAddress: 1st, 5th, 7th Floors, No. 159, Shan-Ying Road, Taoyuan 333, TaiwanWebsite: www.BenQMedicalTech.comCustomer Service e-mail: Service@BenQMedicalTech.comCustomer Service Hotline: Taiwan: 0800-015-533 China: +86 21-6327-7161~3 Ext. 812 International: +886 2-8797-5080 Ext. 59321.1 Intended AudienceThis document is intended for sonographers, physicians, and biomedical engineers who operateand maintain the system and are familiar with ultrasound techniques.1.2 Intended UseThe T3300 is a general-purpose ultrasonic imaging instrument intended for use by a qualifiedphysician for ultrasound evaluation/clinical analysis etc. It can be used in the following applications:Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Vascular (Carotid,Venous, Arterial), Nerve, Renal, Urology and so on.The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.The system is intended to be installed, used, and operated only in accordance with the safetyprocedures and operating instructions given in the system user information, and only for thepurposes for which it was designed.The system should only be operated by someone who has received proper training in the use andoperation of an ultrasound system. This system produces images derived from sound echoes; thoseimages must be interpreted by a qualified medical professional. This system in no way interpretsthese images or provides a medical diagnosis of the patient being examined.WARNINGS• Do not use the system for purposes other than those intended and expressly statedabove. Do not misuse the system, and do not use or operate the system incorrectly.• Do not use the system in ophthalmology applications. • Installation, use, and operation of the system are subject to the law in the jurisdictions inwhich it is used. Install, use, and operate the system only in such ways that do notconflict with applicable laws or regulations, which have the force of law. Use of thesystem for purposes other than those intended and expressly stated here, as well asincorrect use or operation, may relieve us or our agents from all or some responsibilitiesfor resultant noncompliance, damage, or injury.• System users are responsible for image quality and diagnosis. Inspect the data that isbeing used for the analysis and diagnosis, and ensure that the data is sufficient bothspatially and temporally for the measurement approach being used.
Read This FirstT3300 Diagnostic Ultrasound System |3| B00601-010 4/10/171.3 WarningsBefore using the system, read these warnings and "Chapter 2 Safety Information".WARNINGS• Do not attempt to disassemble or modify the system. There are no user serviceable partsinside this system. Necessary modifications must be made only by the manufacturer orits designated agents.• Do not allow any liquid to get inside this system. Water and moisture may cause short-circuit to the electronic components and lead to malfunctions.• Do not drop or apply shock/vibration to this system. Strong impacts may damage thecomponents inside.• Do not cut, bend, modify, place heavy objects, or step on the cable of the power adapter.Otherwise the external insulation may be damaged and result in short-circuit or fire.• Do not use this system near strong electromagnetic sources, such as a microwave oven.The electromagnetic interference may cause this system to malfunction.• To avoid electrical shock, use only supplied power cords and connect only to properlygrounded wall outlets.• The system should not be used adjacent to or stacked with other equipment. If adjacentor stacked use is necessary, the system should be observed to verify normal operation inthe configuration in which it will be used.1.4 WEEEDisposal of Waste Electrical and Electronic Equipment and/or Battery by users in privatehouseholds in the European Union.This symbol on the product or on the packaging indicates that this can not be disposed ofas household waste. You must dispose of your waste equipment and/or battery byhandling it over to the applicable take-back scheme for the recycling of electrical andelectronic equipment and/or battery. For more information about recycling of thisequipment and/or battery, please contact your city office, the shop where you purchasedthe equipment or your household waste disposal service. The recycling of materials willhelp to conserve natural resources and ensure that it is recycled in a manner that protectshuman health and environment.Recycling information: See http://www.benq.com/support/recycle for details.1.5 Discarding the Tablet and BatteriesThe tablet and internal batteries should be discarded in an environmentally safe manner. Properlydispose of batteries according to local regulations.WARNINGS• Do not disassemble, puncture, or incinerate batteries. Be careful not to short the batteryterminals, because that could result in a fire hazard.• Use caution when handling, using, and testing the batteries. Do not short circuit, crush,drop, mutilate, puncture, apply reverse polarity, expose to high temperatures, ordisassemble. Misuse or abuse could cause physical injury.• If embedded electrolyte leakage occurs, wash your skin with large amounts of water toprevent skin irritation and inflammation.
Read This FirstT3300 Diagnostic Ultrasound System |4| B00601-010 4/10/171.6 Equipment ListCheck the sales package for the following items. If any item is missing or damaged, contact yourplace of purchase immediately.• BenQ Medical Technology Ultrasound System• Medical grade AC/DC power adapter• Warranty Card•Basic Operating Instructions (this document)• AC plugs• One or more BenQ Medical Technology TransducersWARNINGS• AC plug types vary by country/region.• Using accessories, transducers, or power supply units other than those specified maycause the warranty to void and result in increased emissions, decreased EMI immunity ofthe system, or even damages to the system and personal injuries.• Use of other accessories results in non-compliance.1.7 ConventionsThe system uses certain conventions throughout the interface to make it easy for you to learn anduse:• Refer to "Controlling the System" on page 43 to control the system using gestures. • To adjust the parameter value of a function, touch the plus/minus buttons (+/-). • To type texts into a text field, touch the field and use the virtual keyboard that appears. You canalso use a supported USB or Bluetooth keyboard for entering texts.• To display a list, touch the down arrow . To display the options, touch the Menu icon . • To select/deselect an item or to enable/disable a function, tap in the checkbox. For example,check the exam ; uncheck the exam . The Basic Operating Instructions uses certain conventions throughout the book to make it easier tofind the information you need.• The on-screen menu steps needed to perform a function are shown in a condensed form. Forexample, touch > Settings >DICOM.• Refer to the following graphic symbols and numbering styles to alert you to importantinformation:This icon marks NOTES; useful tips or additional information that help you get better use of your product.This icon marks CAUTIONS; notices describing actions or conditions that may damage your product or cause injury, and consequently void your warranty or service contract or lose the patient or system data.This icon marks WARNINGS; instructions that must be followed. Failure to observe can cause damages to your product, or result in personal injuries, or even death.
Read This FirstT3300 Diagnostic Ultrasound System |5| B00601-010 4/10/171.8 System WarrantyThe warranty is void if unauthorized personnel perform service or maintenance on the system. To ensure correct system performance and to obtain warranty service, please contact technical support. For more information, see "Contact Information" on page 2. This Device is for medical care person use only.Only Professionals can install it. To maintain the device operation during the line power off, the device is battery included.
T3300 Diagnostic Ultrasound System |6| B00601-010 4/10/17CHAPTER2Safety InformationThis chapter covers the following topics:•"Symbols" on page 8•"Electrical Safety" on page 10•"Mechanical Safety" on page 15•"Equipment Protection" on page 15•"RF Safety" on page 16•"Biological Safety" on page 16•"Operator Safety" on page 18•"Waterproof and Dustproof Ratings" on page 19•"Understanding the MI/TI Display" on page 19•"Transducer Surface Temperature Rise" on page 22
Safety InformationT3300 Diagnostic Ultrasound System |7| B00601-010 4/10/17WARNINGFollow the procedures carefully and ensure that the power/electrical/environmentalrequirements are satisfied. Failure to observe the instructions or disregard the warnings mayresult in damages to the system, personal injury, or even death of the operator or the patient.Observe the following precautions carefully.WARNINGS• This system complies with Type BF general equipment and the EN60601-1 standard,suitable for continuous operation when connected as a system to a medical grade AC/DCpower adapter or operated from the tablet battery.• Use only medical grade peripherals in the patient environment.• Do not block or otherwise obstruct access to the AC plug at the wall. Operators must beable to quickly unplug the power cable at the wall in case of emergency.• The system should only be used in a medical facility under the supervision of a trainedphysician.• Only an authorized service technician should perform maintenance.• Be extremely cautious when placing or moving the system.• Always position the system on a stable surface where it cannot fall on the patient.• Do not lift the system by the power cable or the transducer. If either disconnects, thesystem could fall on the patient.• This system has been fully adjusted and tested prior to shipment from the factory.Unauthorized modifications will void your warranty.• If this system or the transducer connected displays any signs of malfunction, turn off thesystem immediately, disconnect it from the wall outlet, then contact technical support(See "Contact Information" on page 2)• Do not use a power adapter other than the one supplied with the system. Connecting thesystem to an unknown power adapter is very dangerous and may lead to fire orexplosion.• Using cables, transducers, or accessories other than those specified for use with thesystem may result in increased emissions or decreased immunity of the system.• The power cable of the system should only be connected to a grounded power socket.• Do not connect USB peripherals with an extended USB cable. Extended connection maycause unexpected usage fault.• Only devices that comply with the EN60601-1 standard, either electronically ormechanically, can be connected to this system. Recheck the leakage current and othersafety performance indices of the entire system to avoid potential system damagecaused by leakage from a current superposition.CAUTIONCAUTIONUsing accessories, transducers, peripherals, or cables not supplied with the system orrecommended by BenQ Medical Technology can affect the system in the form of increasedemissions or decreased immunity to external EMI/EMC occurrences. Non-specifiedperipherals, and cables in some cases, can also increase leakage current or compromise thesafety of the grounding scheme.• This system does not incorporate any specialized protective measures in the event it isconfigured with high-frequency operation devices. The operator should use with cautionin these types of applications.• The system is in compliance with the Ingress Protection Marking ratings IP21.
Safety InformationT3300 Diagnostic Ultrasound System |8| B00601-010 4/10/17WARNINGS• Do not use this system under direct sunlight, near heat sources or in the presence offlammable substances, otherwise an explosion may occur.• When using this system for ultrasound examinations, use only the qualified ultrasoundgel that complies with system standards.• Do not continuously scan the same part of a patient or expose the patient to prolongedscanning, otherwise it may harm the patient.• Do not stay at the same position for too long without taking a break while scanningpatients to prevent harm or neck injury.• Follow the instructions on "Chapter 4 Preparing the System" on page 31 in this BasicOperating Instructions for complete instructions on the installation of the transducers,power supply units and all peripheral devices to the system.• Improper installation of peripherals to the system may cause damage to the system,peripherals, or personal injury to the operator or the patient.• Do not use the system for any application until you have read, understood, and know allthe safety information, safety procedures, and emergency procedures contained in thischapter. Operating the system without a proper awareness of safe use could lead to fatalor other serious personal injury.• The system can contain environmentally hazardous materials such as, but not limited to:heavy metals, general recyclable metals, and plastics. This product should be recycledaccording to local and national guidelines for recycling electronic equipment.• When using additional peripheral equipment powered from an electrical source otherthan the ultrasound system, the combination is considered to be a medical system. It isyour responsibility to comply with IEC 60601-1 and test the system to thoserequirements.• Do not use non-medical peripherals, such as report printers, within 1.5 m (5 ft) of apatient, unless the non-medical peripherals receive power from an isolation transformerthat meets medical safety standards, as defined by standard IEC 60601-1.• Images printed on a report printer are intended only for reference and should not be usedfor diagnostic purposes.• For proper disposal of this system, contact your local BenQ Medical Technologyrepresentative.2.1 SymbolsThe following symbols provide information about the system’s labels and regulatory compliance.CAUTIONCAUTIONDo not use a brush on the system’s labels.
Safety InformationT3300 Diagnostic Ultrasound System |9| B00601-010 4/10/172.1.1 System Label Icons2.1.2 System ButtonTable 1 System Label IconsSymbols DescriptionsProduct ModelUnique Device IdentificationManufacturer MarkManufacturerQisda Corporation manufactures the system.Manufacture DateEU/EC European Authorized RepresentativeCE Marking Certification with Notified Body Number 0120Compliance to R&TTE DirectiveFinal Disposal of Your SystemFinal disposal is when you dispose of the system in such a way that it can no longer be used for its intended purposes.For more information, see "WEEE" on page 3. Refer to the Basic Operating InstructionsIndicates that the user should read the Basic Operating Instructionsfor information on using this equipmentType BF Equipment Applied PartThe Ultrasound System provides protection against electric shock.Include RF transmitters, apply RF electromagnetic energy for diagnosisTablet IP Code, International Protection MarkingTable 2 System ButtonSymbols DescriptionsPower buttonPress and hold the Power button to turn on/off the system.
Safety InformationT3300 Diagnostic Ultrasound System |10 | B00601-010 4/10/172.1.3 Shipping Label Icons2.2 Electrical SafetyOnly trained medical personnel should operate this system. This system complies with the followingstandards:• Electrical:– IEC 60601-1:2005+AMD1:2012/EN 60601-1:2006+A1:2013+A12:2014– IEC 60601-2-37:2008+AM1:2011•EMC/EMI:– IEC 60601-1-2:2007/AC:2010, CISPR 11 Group I Class BTable 3 Shipping Label IconsSymbols DescriptionsThis Side UpFragileMaximum Stacking HeightMaximum Stacking WeightSun and RainTemperatureThe system must be stored in the original shipping container in environments between -20°C and 60°C (-13°F and 140°F). The temperature while operating the system should be kept between 10°C and 40°C (32°F and 104°F).HumidityThe system must be stored in the original shipping container in environments with 20% to 95% relative humidity and non-condensing. The humidity while operating the system should be kept between 20% to 85% relative humidity and non-condensing.Air PressureThe system must be stored in the original shipping container in environments between 700 hPa (525 mmHg) and 1060 hPa (795 mmHg) air pressure.
Safety InformationT3300 Diagnostic Ultrasound System |11 | B00601-010 4/10/17• Harmful liquid protection:– For the main system: IP21 (without power adapter)– For the transducer: IPx7– For the power adapter: IP20– For maximum safety, observe the following guidelines strictly:WARNINGS• The system and patient-applied parts meet the standard IEC 60601-1. Applied voltagesexceeding the standard, although unlikely, may result in electrical shock to the patient oroperator.• Shock hazards exist if the power adapter is damaged or is not properly grounded. Useonly the supplied medical grade power adapter.• Plug the system into a hospital-grade, three-hole outlet, and do not circumvent the powercord.• To avoid the risk of electric shock, connect the system only to properly grounded walloutlets.• Only authorized service technicians can make internal replacements of the system.• Do not operate the system in the presence of flammable gases or anesthetics. Explosioncan result. The system is not compliant in AP/APG environments as defined by IEC60601-1.• Do not use a transducer if the transducer or cable is damaged. Contact technical supportfor replacement of the damaged equipment (See "Contact Information" on page 2).• All peripheral devices connected to the system must comply with IEC 60601 or IEC 60950-1.• To avoid risk of electrical shock hazards, always inspect the transducer before use.Check the face, housing, and cable before use. Do not use if the face is cracked, chipped,or torn; the housing is damaged; or the cable is abraded.• Transducer cables have strain reliefs at terminations. Inspect cables regularly to detectdamaged, frayed, or broken cables that might contact a patient.2.2.1 Battery Usage/DisposalWARNINGS• Do not disassemble the system.• Use only the supplied battery. Using an unapproved battery may cause the system toexplode and result in serious damage to your health or property.• Do not replace, heat, crush, puncture, short external contacts, or incinerate the battery.• Use only the supplied power adapter to charge the battery.• Incorrect use of the battery may cause a leak of chemicals or explosion. The leak ofchemicals may harm the skin. If any chemicals leak from the device, use a dry cloth towipe it clean and contact your local BenQ Medical Technology representative for help.CAUTIONCAUTIONDispose of used batteries according to the instructions.2.2.2 Electrical Fast Transients (EFT)The system complies with the IEC 60601-1-2 3rd edition standard for susceptibility to electrical fasttransients (EFT) on the power line. However, if the system experiences EFT on the power line,
Safety InformationT3300 Diagnostic Ultrasound System |12 | B00601-010 4/10/17artifacts (vertical lines, excessive noise in image, etc.) may appear on the ultrasound image. Toeliminate these artifacts caused by an EFT condition, the operator should either:• Disconnect the system from the power source by unplugging the power cord from the tablet, andrun the system on its internal battery.or• Unplug the power cord from the wall and move to a different power source that is notexperiencing this condition.2.2.3 Electromagnetic Interference (EMI)Medical electrical equipment such as the system requires special precautions regardingelectromagnetic compatibility, and must be installed and put into service according to the followingelectromagnetic tables.2.2.3.1 All EquipmentThe system is intended for use in the electromagnetic environment specified below. The customer oroperator of the T3300 Diagnostic Ultrasound System should ensure that it is used in such anenvironment.Guidance and Manufacturer’s Declaration - Electromagnetic Emissions - All EquipmentGuidance and Manufacturer’s Declaration - Electromagnetic Immunity - All EquipmentTable 4 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions - All EquipmentEmissions test Compliance Electromagnetic environment - GuidanceRF Emissions CISPR 11 Group 1The T3300 Diagnostic Ultrasound 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 B The T3300 Diagnostic Ultrasound System is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonics IEC 61000-3-2 Class A or BFlicker IEC 61000-3-3 CompliesRF Emissions CISPR 14-1 Complies The T3300 Diagnostic Ultrasound System is not suitable for interconnection with other equipment.RF Emissions CISPR 15 Complies The T3300 Diagnostic Ultrasound System is not suitable for interconnection with other equipment.Table 5 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - All EquipmentImmunity test IEC 60601 test level Compliance level Electromagnetic environment - GuidanceESDIEC 61000-4-2 ±6 kV Contact±8 kV Air As specifiedFloors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.EFTIEC 61000-4-4 ±2 kV Mains± 1kV I/Os As specified Mains power quality should be that of a typical commercial or hospital environment.Surge IEC 61000-4-5 ±1 kV Differential±2 kV Common As specified
Safety InformationT3300 Diagnostic Ultrasound System |13 | B00601-010 4/10/17Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - Non-life-supportingEquipmentVoltage dips/Dropout IEC 61000-4-11>95% dip for 0.5 cycle60% dip for 5 cycles30% dip for 25 cycles>95% dip for 5 secondsAs specifiedMains power quality should be that of a typical commercial or hospital environment. If the user of the T3300 Diagnostic Ultrasound System requires continued operation during power mains interruptions, it is recommended that the T3300 Diagnostic Ultrasound System be powered from an uninterruptible power supply or battery.Powerfrequency 50/60 Hz Magnetic field IEC 61000-4-83 A/m As specifiedPower frequency magnetic fields should be that of a typical commercial or hospital environment.Table 6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - Non-life-supporting EquipmentImmunity test IEC 60601 test level Compliance level Electromagnetic environment - GuidancePortable and mobile RF communications equipment should be used no closer to any part of the T3300 Diagnostic Ultrasound System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distanceConducted RFIEC 61000-4-6 3 Vrms150 KHz to 80 MHz [V1] = 3 VrmsRadiated RFIEC 61000-4-3 3 V/m80 MHz to 2.5 GHz [E1] = 3 V/m 80 MHz to 800 MHz 800 MHz to 2.5 GHzTable 5 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - All EquipmentImmunity test IEC 60601 test level Compliance level Electromagnetic environment - Guidanced3.5V1----------P=d3.5E2----------P=d7E2-------P=
Safety InformationT3300 Diagnostic Ultrasound System |14 | B00601-010 4/10/17To limit exposure to electromagnetic interference from nearby equipment that can degrade imagequality, you should operate the system under EMI conditions that minimize power supply transients,mechanical interactions, vibration, and thermal, optical, and ionizing radiation.WARNINGS• Using cables, transducers, and accessories other than those specified for use with thesystem may result in increased emissions from, or decreased immunity of, the system.• ME equipment has been tested for radiated RF immunity only at selected frequencies.2.2.3.2 Separation DistancesThe T3300 Diagnostic Ultrasound System is intended for use in the electromagnetic environment inwhich radiated disturbances are controlled. The customer or operator of the system can helpprevent electromagnetic interference by maintaining a minimum distance between portable andWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya,should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the T3300 Diagnostic Ultrasound System is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Table 6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - Non-life-supporting EquipmentImmunity test IEC 60601 test level Compliance level Electromagnetic environment - Guidance
Safety InformationT3300 Diagnostic Ultrasound System |15 | B00601-010 4/10/17mobile RF Communications Equipment and the system as recommended below, according to themaximum output power of the communications equipment.For transmitters rated at a maximum output power not listed above, the recommended separationdistance Din meters (m) can be estimated using the equation applicable to the frequency of thetransmitter, where P is the maximum output power rate of the transmitter in watts (W) according tothe transmitter manufacturer.NOTES• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.WARNINGOperation of the equipment below that value may cause inaccurate results.2.2.4 Surges to AC Power MainsIf the system is powered from AC mains that could experience surges above 1 kV (for example, fromextreme lightning conditions), additional surge suppression is recommended.2.3 Mechanical SafetyObserve the following precautions when using the system for mechanical safety.WARNINGS• When attempting to overcome an obstacle, do not push the system from either side withexcessive force, which could cause the system to tip over.• When positioning the system, move it carefully to avoid pinching hands or extremitiesagainst other objects, such as a bed rail.• Do not roll the system over transducer cables or power cords.2.4 Equipment ProtectionObserve the following precautions to protect your system.Table 7 Separation distancesMaximumOutput Power of TransmitterWatts (W)Separation Distance According to Frequency of Transmitter Meters (m)150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 0.12 m 0.12 m 0.24 m0.1 0.37 m 0.37 m 0.74 m1 1.17 m 1.17 m 2.34 m10 3.69 m 3.69 m 7.38 m100 11.67 m 11.67 m 23.34 m3.5 PV2------------------- D=3.5 PE2------------------- D=7PE2------------- D=
Safety InformationT3300 Diagnostic Ultrasound System |16 | B00601-010 4/10/17CAUTIONCAUTION• Excessive bending or twisting of cables on patient-applied parts may cause failure orintermittent operation of the system. Do not roll the system over cables, which maydamage them.• Do not submerge the cables of patient-applied parts in solution. The cables are not liquid-tight beyond the applied part/cable or cable/connector interfaces.• Do not submerge the transducer connector in any liquid.• For optimal performance, connect your system to a circuit dedicated solely for thesystem. Do not connect life-support devices to the same circuit as the system.• Improper cleaning or sterilization of a patient-applied part may cause permanent damage.For cleaning and disinfection instructions, see "Transducer and System Maintenance" onpage 93.2.5 RF SafetyThe system should be operated in a location that is no closer than listed in “Non-Life-SupportingEquipment” to any part of RF communications equipment that may disturb its functions. If abnormalperformance is observed, additional measures may be necessary, such as re-orienting or relocatingthe equipment. The system should be separated by at least the distances specified in the tablereferenced above. The system is intended for use in an electromagnetic environment where radiated RF disturbancesare controlled. The customer or the user of the system can help prevent electromagneticinterference by maintaining a minimum distance between portable and mobile RF communicationsequipment (transmitters) and the system according to the maximum output power of thecommunications equipment.2.6 Biological SafetyThis product, as with all ultrasound equipment, should be used only for valid reasons and should beused both for the shortest period of time and at the lowest power settings necessary (ALARA - AsLow As Reasonably Achievable) to produce diagnostically acceptable images. The AIUM offers thefollowing guidelines:Clinical Safety Quoted from AIUMApproved March 26, 1997Diagnostic ultrasound has been in use since the late 1950s. Given its known benefitsand recognized efficacy for medical diagnosis, including use during humanpregnancy, the American Institute of Ultrasound in Medicine herein addresses theclinical safety of such use.There are no confirmed biological effects on patients or instrument operators causedby exposures from present diagnostic ultrasound instruments. Although the possibilityexists that such biological effects may be identified in the future, current data indicatethat the benefits to patients of the prudent use of diagnostic ultrasound outweigh therisks, if any that may be present.
Safety InformationT3300 Diagnostic Ultrasound System |17 | B00601-010 4/10/172.6.1 HeatingElevating tissue temperature during obstetrical examinations creates medical concerns. At theembryo development stage, the rise in temperature and the length of time exposed to heat combineto determine potential detrimental effects. Exercise caution, particularly during Color imaging exams.The Thermal Index (TI) provides a statistical estimate of the potential temperature elevation (incentigrade) of tissue temperature. Two forms of TI are available: TIS, for soft tissue exposures; andTIB, for instances when bone lies near the beam focus.2.6.2 CavitationCavitation may occur when sound passes through an area that contains a cavity, such as a gasbubble or air pocket (in the lung or intestine, for example). During the process of cavitation, thesound wave may cause the bubble to contract or resonate. This oscillation may cause the bubblesto explode and damage the tissue. The Mechanical Index (MI) has been created to help operatorsaccurately evaluate the likelihood of cavitation and the related adverse effects. 2.6.3 Safe Scanning Guideline• Ultrasound should only be used for medical diagnosis and only by trained medical personnel.WARNINGS• Diagnostic ultrasound procedures should be done only by personnel fully trained in theuse of the system, in the interpretation of the results and images, and in the safe use ofultrasound (including education as to potential hazards).• Operators should understand the likely influence of the machine controls, the operatingmode (e.g. B-mode, Color or Spectral Doppler) and the transducer frequency on thermaland cavitation hazards.• Use a low output power default setting for each new patient. Output should only be increasedduring the examination if penetration is still required to achieve a satisfactory result, and after theGain control has been adjusted to its maximum value.• Maintain the shortest examination time necessary to produce a useful diagnostic result.WARNINGS• Take particular care to reduce output and minimize exposure time of an embryo or fetuswhen the temperature of the mother is already elevated.• Take particular care to reduce the risk of thermal hazard during diagnostic ultrasoundwhen exposing an embryo less than eight weeks after gestation, or the head, brain orspine of any fetus or neonate.• Although applicable to any transducer, take particular care during trans-vaginal examsduring the first eight weeks of gestation.• During continuous operation, the system temperature may become too high. If the followingsystem message displays during a real-time scan, touch OK and the system displays frozenimaging screen. To resume scanning, wait until the system cools down. • Operators should continually monitor the on-screen thermal index (TI) and mechanical index(MI) values and use control settings that keep these settings as low as possible while stillachieving diagnostically useful results. In obstetric examinations, TIS (soft tissue thermal index)System temperature is high. Please ceasethe current scan for a few minutes. OK
Safety InformationT3300 Diagnostic Ultrasound System |18 | B00601-010 4/10/17should be monitored during scans carried out in the first eight weeks after gestation, and TIB(bone thermal index) thereafter.– MI> 0.3 Minor damage is likely to happen to neonatal lung or intestine. If such exposure isnecessary, reduce the exposure time as much as possible.– MI> 0.7 Risk of cavitation exists if an ultrasound contrast agent containing gas microspheresis being used. There is a theoretical risk of cavitation without the presence ofultrasound contrast agents. The risk increases with MI values above this threshold.– TI> 0.7 The overall exposure time of an embryo or fetus should be restricted in accordancewith the following table as a reference.• Diagnostic ultrasound has the potential for both false positive and false negative results.Misdiagnosis is far more dangerous than any effect that might result from the ultrasoundexposure. Therefore, diagnostic ultrasound should be performed only by those with sufficienttraining and education.• Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of non-diagnostic uses of ultrasound equipment include repeated scans for operator training,equipment demonstration using normal subjects, and the production of souvenir pictures orvideos of a fetus. For equipment of which the safety indices are displayed over their full range ofvalues, the TI should always be less than 0.5 and the MI should always be less than 0.3. Avoidfrequent repeated exposure of any subject. Scans in the first trimester of pregnancy should notbe carried out for the sole purpose of producing souvenir videos or photographs, nor should theirproduction involve increasing the exposure levels or extending the scan times beyond thoseneeded for clinical purposes.2.7 Operator SafetyThe following issues and situations can affect operator safety when you are using an ultrasoundsystem.2.7.1 Infection ControlIssues related to infection control affect the operator and the patient. Follow the infection-controlprocedures established in your facility for the protection of both the staff and the patient.2.7.2 Disposable DrapeIf you believe contamination of the system might occur during an exam, it is recommended that youtake universal precautions and cover the system with a disposable drape. Consult your facility'srules regarding equipment use in the presence of infectious disease.Table 8 Maximum exposure time recommended for an embryo or fetusTI Maximum exposure time (minutes)0.7 601.0 301.5 152.0 42.5 1
Safety InformationT3300 Diagnostic Ultrasound System |19 | B00601-010 4/10/172.8 Waterproof and Dustproof RatingsThe system has a degree of protection from ingress of water and particulate matter, but the tablet isnot approved for use where it would be exposed to liquids. If it is used in environments where itmight be exposed to liquids, the tablet must be covered by a drape. These environments include, butare not limited to, outpatient and private office procedures such as biopsies, office visits, and othertraditional, non-invasive scanning.The following table lists the applied parts and their levels of protection.2.9 Understanding the MI/TI DisplayThe system allows full software control of acoustic output. When powering on the system or creatinga new exam, scan parameters should be set to default preset. All of the default presets arecompliant with FDA requirements. TI/MI information are displayed in real-time in the scan propertiesarea.In the following table, the MI or TI index is equal or greater than 1.0 for transducer/modecombinations marked “V”.Table 9 Waterproof and dustproof ratingsComponent Use IP levelUltrasound System Ultrasound system IP21P42B6 transducer Ultrasound transducer IPX7 (at transducer head)C62B transducer Ultrasound transducer IPX7 (at transducer head)L154BH transducer Ultrasound transducer IPX7 (at transducer head)Table 10 MI/TI generating from applicable transducer/mode combinationsMode / TransducerP42B6 Phased Array 64 elements 2-4 MHzC62B Curved Linear Array 2-6 MHzL154BH Linear Array 4-12 MHzBV ௅௅B+Color V V VB+Power V V VB+M-Mode V ௅௅PW Doppler ௅V௅Save FreezeHomeTGCTuningResolutionGeneralPenetrationEnd ExamAbdomenGainDepthFocusTHI Full ScreenBColor PWMPowerBFn Key
Safety InformationT3300 Diagnostic Ultrasound System |20 | B00601-010 4/10/17Track-3 follows the Output Display Standard for systems which include fetal Doppler applications.The acoustic output will not be evaluated on an application-specific basis, but the global maximumde-rated Ispta must be  720 mW/cm2and either the global maximum MI must be  1.9, or the globalmaximum derated Isppa must be  190 W/cm2. An exception is for ophthalmic use, in which casethe TI=max (TIS) is not to exceed 1.0; Ispta.3  50 mW/CM2, and MI  0.23. Track-3 gives theoperator the freedom to increase the output acoustic power for a specific exam, and still limit outputacoustic power within the global maximum de-rated Ispta  720 mW/cm2 under an Output DisplayStandard.The system design allows full software control of the acoustic output, entry of new patientidentification data or change from a non-foetal to a foetal application, and the system may switch toan appropriate default setting upon powering on. These default setting levels are established beforeshipping and may be reconfigured by the operator.For any ultrasound systems, Track-3 provides an Output Indices Display Standard. The ultrasoundsystem and its Basic Operating Instructions contain the information regarding an ALARA (As Low AsReasonably Achievable) education program from the clinical end-user and the acoustic outputindices, MI and TI. The MI describes the likelihood of cavitation, and the TI offers the predictedmaximum temperature rise in tissue as a result of the diagnostic examination. In general, atemperature increase of 2.5°C must be present consistently at one spot for 2 hours to causepossible fetal abnormalities. Avoiding a local temperature rise above 1°C should ensure that nothermally induced biologic effect occurs. When referring to the TI for potential thermal effect, a TIequal to 1 does not mean the temperature will rise 1°C. It only means an increased potential forthermal effects can be expected as the TI increases. A high index does not mean that bioeffects areoccurring, but only that the potential exists and there is no consideration in the TI for the scanduration, so minimizing the overall scan time will reduce the potential for effects. These operatorcontrol and display features move the safety responsibility from the manufacturer to the operator. Soit is very important to have the ultrasound systems display the acoustic output indices correctly andthe well-educated operator to interpret the value appropriately.RF: De-rating factorIn Situ intensity and pressure cannot currently be measured. Therefore, the acoustic powermeasurement is normally done in the water tank, and when soft tissue replaces water along theultrasound path, a decrease in intensity is expected. The fractional reduction in intensity caused byattenuation is denoted by the derating factor (RF),RF = 10 (-0.1 a.f.z)Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and zis the distance along the beam axis between the source and the point of interest.De-rating factor RFfor the various distances and frequencies with attenuation coefficient 0.3 dB cm-1MHz-1 in homogeneous soft tissue is listed in the following table. An example is if the operator usesTriplex V V ௅CW Doppler ௅௅௅Table 10 MI/TI generating from applicable transducer/mode combinationsMode / TransducerP42B6 Phased Array 64 elements 2-4 MHzC62B Curved Linear Array 2-6 MHzL154BH Linear Array 4-12 MHz
Safety InformationT3300 Diagnostic Ultrasound System |21 | B00601-010 4/10/177.5 MHz frequency, the power will be attenuated by 0.0750 at 5 cm, or 0.3 x 7.5 x 5 = -11.25 dB. TheDe-rated Intensity is also referred to as ‘.3’ at the end (e.g. Ispta.3).I’ = I * RFWhere I’ is the intensity in soft tissue, I is the time-averaged intensity measured in water.2.9.1 TITI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raisetissue temperature by 1°C (Wdeg),TI = W.3 / WdegThree TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatalcephalic; and cranial bone (TIC) for pediatric and adult cephalic, have been developed forapplications in different exams. An estimate of the acoustic power in milliwatts necessary to producea 1°C temperature elevation in soft tissue is:Wdeg = 210 / fcFor model 1 to 4, where fc is the center frequency in MHz.Wdeg = 40 · K · DFor model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in cm at the depthof interest.2.9.2 MICavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave inthe tissue, which contains a bubble or air pocket (for instance, the lung, intestine, or scan with gascontrast agents). The threshold under optimum conditions of pulsed ultrasound is predicted by theratio of the peak pressure to the square root of the frequency.MI = Pr’ / sqrt(fc)Pr’ is the de-rated (0.3) peak rare-fractional pressure in Mpa at the point where PII is the maximum,and fc is the center frequency in MHz. PII is the Pulse Intensity Integral that the total energy per unitarea carried by the wave during the time duration of the pulse. The peak rare-fractional pressure ismeasured in hydrophone maximum negative voltage normalized by the hydrophone calibrationparameter.2.9.2.1 Display GuidelineThermal Index (TI) consists of two indices: soft tissue (TIS) and bone (TIB). TIB is only displayed innon-scanning modes, such as M-mode, PW mode and CW mode. TIS is displayed in all scanTable 11 Distance (cm) Frequency (MHz)1 3 5 7.51 0.9332 0.8128 0.7080 0.59572 0.8710 0.6607 0.5012 0.35483 0.8128 0.5370 0.3548 0.21134 0.7586 0.4365 0.2512 0.12595 0.7080 0.3548 0.1778 0.07506 0.6607 0.2884 0.1259 0.04477 0.6166 0.2344 0.0891 0.02668 0.5754 0.1903 0.0631 0.0158
Safety InformationT3300 Diagnostic Ultrasound System |22 | B00601-010 4/10/17modes. The index is continuously displayed over a range of 0.1 to 6.0 in increments of 0.01.Mechanical Index (MI) is continuously displayed over a range of 0.1 to 1.9 in increments of 0.01.2.9.3 Display and Report in Different Modes2.9.3.1 For B-ModeDisplay and report only MI and TIS2.9.3.2 For Color ModeDisplay and report only MI and TIS2.9.3.3 For Doppler ModeDisplay and report MI, TIS and TIBBelow is a simple guideline for the operator when TI exceeds one limit exposure time to 4(6-TI) minutesbased on the‘National Council on Radiation Protection. Exposure Criteria for Medical DiagnosticUltrasound: I. Criteria Based on Thermal Mechanisms. Report No.113 1992’.2.9.4 Operator Control FeaturesThe operator should be aware that certain operator controls may affect the acoustic output. It isrecommended to use the default (or lowest) output power setting and compensate using Gaincontrol to acquire an image. Other than the output power setting in the Soft Menu, which has themost direct impact on the power; the PRF (Pulse Repetition Frequency), image sector size, framerate, depth, and focal position also slightly affect the output power. The default setting is normallyaround 70%, occasionally 90%, of the allowable power, depending on the exam type.2.10 Transducer Surface Temperature RiseThe table below lists the measured surface temperature rise from ambient (23°C ± 3°C) oftransducers used on the system. The temperatures were measured in accordance with EN 60601-2-37 cl.201.11 and cl.201.13 with controls and settings positioned to give maximum temperatures.Table 12 Transducer surface temperature riseTest External use (°C)P42B6 C62B L154BHSimulated use 1.4 1.5Still air 3.6 7.3 6.5
T3300 Diagnostic Ultrasound System |23 | B00601-010 4/10/17CHAPTER3OverviewAcquaint yourself with the system and its components in this chapter. This chapter covers the following topics:•"System Capabilities" on page 24•"System Overview" on page 26•"Transducer Overview" on page 29•"Indications for Use and Supporting Transducers" on page 29
OverviewT3300 Diagnostic Ultrasound System |24 | B00601-010 4/10/173.1 System CapabilitiesThe T3300 Ultrasound System is intended for Obstetric imaging, Gynecology imaging, Cardiacimaging, Vascular imaging, and general imaging purpose, and related analysis. The system can beused for 2D grayscale (B-Mode), M-Mode, Color, Power, PW and CW imaging depending on thetransducer. The system also supports duplex, and triplex imaging. The system providesmeasurement tools, analysis options, and DICOM network capabilities. Refer to the followingstandard features.3.1.1 ImagingThe following scan modes and features are available, if supported by the transducer for theapplication:• B-mode•M-mode• Color Doppler• Power mode• PW mode• CW mode• Tissue Harmonic Imaging (THI)• QScan image processing• SQBeam Real-time Compound Imaging• FQBeam Real-time Compound ImagingWARNINGThe system does not support the biopsy guide function. Do not use nor assemble any kind ofneedle guide kits/brackets on the supported transducer to avoid transducer damage orhurting the patient.3.1.2 Transducer TypesThe available transducer types are a curved linear array transducer, a linear array transducer and aphased array transducer. Applications for specific transducers are listed in "Indications for Use andSupporting Transducers" on page 29.3.1.3 MeasurementsThe system provides tools and controls for measuring distance, ellipse, angle, trace and IMT. Afteryou perform measurements, the system makes the pertinent calculations and organizes themeasurements, calculations, and patient information, which can be added into a patient report.3.1.4 CalculationsCalculations are organized by applications supported by the system. The system usesmeasurement values to perform calculations which can then be added into a patient report.3.1.5 Image Acquisition and ReviewYou can acquire and review single images and cineloop sequences. Images and cineloopsequences can be stored on USB devices, or sent over a wireless network to an archive server, orprinted out from supported external printers.
OverviewT3300 Diagnostic Ultrasound System |25 | B00601-010 4/10/173.1.6 ConnectivityThe following features are standard:• Patient Data and Settings export to removable media• USB and Bluetooth connectivity to peripheral devices such as a Keyboard (not supplied with thesystem)• HDMI connectivity to secondary monitors• Printing to local/network printers• Wireless and Wired networking• DICOM networking• Patient data imported from MWL server• Image export to network storage
OverviewT3300 Diagnostic Ultrasound System |26 | B00601-010 4/10/173.2 System Overview3.2.1 Front and Side ViewsTable 1 Front and Side ViewsNo. Component FunctionTouch screen Display system information and allow you to perform operations using different gestures.Speakers Built-in speakers for playing sounds, which are software-controlled.Transducer connection socket Connect a transducer to the system. (See page 34)Battery indicatorWhen the system is connected to power:• If the system is turned off or enters sleep mode,the battery indicator behaves in the followinglighting patterns:– Steadily on orange when the battery is charging.– Steadily on green after the battery is charged.• If the system is turned on, the battery indicatorlights off.To monitor the battery level, see "Battery Status Icons" on page 53.Power indicator Blink blue after the system enters Sleep mode. (Seepage 52)MicroSD card slot Insert a microSD card into the microSD card slot to exchange data from/to the system. (See page 32)AUX port For use by authorized service personnel onlyHDMI port Connect the system to an HDMI (High-Definition Multimedia Interface) device. (See page 39)
OverviewT3300 Diagnostic Ultrasound System |27 | B00601-010 4/10/17NOTEThe system supports access to only one external storage device at a time. If you connect more thanone external storage device, they function in the following priority order: USB 3.0 > USB 2.0 >microSD card.Ethernet socket Connect the system to an Ethernet-based network. (See page 54)USB 2.0 port Connect the system to USB 2.0 devices, such as keyboards, pointing devices, or portable storage devices.USB 3.0 port Connect the system to USB 3.0 devices, such as keyboards, pointing devices, or portable storage devices.Headphone jack Connect the system to an audio device, such as headphones or speakers.Table 1 Front and Side ViewsNo. Component Function
OverviewT3300 Diagnostic Ultrasound System |28 | B00601-010 4/10/173.2.2 Rear and Top/Bottom ViewsTable 2 Rear and Top/Bottom ViewsNo. Component FunctionVentilation slots Release excessive heat during operation to keep the system in a safe operating temperature.Power input socket Used to connect the system to power. (See "Charging the System" on page 33)Anti-theft lock slot Used to lock the system securely to a solid surface to protect it from theft.System stand• Lift the stand to sustain the systemon a flat surface. (See "Using theStand" on page 33)• Can be used as a handle to carry thesystem around. (See "Using theSystem On The Go" on page 37)Power button Press and hold the Power button to turn on/off the system.
OverviewT3300 Diagnostic Ultrasound System |29 | B00601-010 4/10/173.3 Transducer OverviewNOTEUse only transducers that are approved by BenQ Medical Technology for use with the system.3.3.1 Clinical Applications and TransducersA clinical application, available for one or more transducers, optimizes the system for a specificapplication. A clinical application consists of exam-specific presets, and the correspondingmeasurement and calculation packages.The clinical applications for each transducer available for the system are listed in the following table.For more information, see "Indications for Use and Supporting Transducers" on page 29. 3.4 Indications for Use and Supporting TransducersThe T3300 Diagnostic Ultrasound System is a general-purpose ultrasonic imaging instrumentintended for use by a qualified physician for evaluation of Abdomen, Cardiology, Gynecology,Obstetric, Breast, Thyroid, Vascular (Carotid, Venous, Arterial), Nerve, Renal, Urology and so on.Table 3 Transducer overview (Example transducer: C62B)No. Component No. ComponentTransducer handle Transducer cableTransducer connector Release latchConnector strain relief Transducer strain reliefOrientation marker Transducer lensTable 4 Clinical Applications and TransducersTransducer Clinical ApplicationsP42B6 CardiacC62B Abdomen, OB, Renal, Urology, GYNL154BH Carotid, Arterial, Venous, Thyroid, Breast, MSK, Nerve
OverviewT3300 Diagnostic Ultrasound System |30 | B00601-010 4/10/17The following table provides Diagnostic Ultrasound Indications for Use Forms for the transducersoffered with the T3300 Diagnostic Ultrasound System.Table 5 Indications for Use and Supporting TransducersIndications for Use Supporting TransducersCardiac Adult P42B6Obstetric C62BMusculoskeletal (Conventional) L154BHPeripheral Vessel L154BHSmall Parts (Breast, Thyroid) L154BHUrology C62BAbdomen C62B
T3300 Diagnostic Ultrasound System |31 | B00601-010 4/10/17CHAPTER4Preparing the SystemFollow the information and procedures in this section to help you preparethe system for use. This chapter covers the following topics:•"Inserting a microSD Card" on page 32•"Using the Stand" on page 33•"Charging the System" on page 33•"Installing the Transducer Holder" on page 34•"Connecting the Transducer" on page 35•"Removing the Transducer" on page 36•"Using the System On The Go" on page 37•"Outputting the System Display to an HDMI-Enabled TV or Monitor"on page 39
Preparing the SystemT3300 Diagnostic Ultrasound System |32 | B00601-010 4/10/174.1 Inserting a microSD CardUse the microSD card to import/export data to/from your system, such as patient information or usersettings.NOTES• Supported microSD card format: SDXC (up to 128GB); SDHC Class 10 (up to 32GB)• The microSD card is not supplied with the system.• You can also use external USB 2.0 or 3.0 flash drives to import/export data through USB ports.Both the microSD card and the USB flash drives must be formatted in FAT32 format.1. Flip the port cover open.2. Align the microSD card with the mark next to the microSD card slot.3. Fully insert the microSD card into the card slot until it clicks into place.NOTES• You can use the system’s service tools to back up system settings and patient data when thesystem is connected to an external storage device. For more information, see "Backing UpSystem Settings and Patient Data" on page 92. • The system supports access to only one external storage device at a time. If you connect morethan one external storage device, they function in the following priority order: USB 3.0 > USB2.0 > microSD card.
Preparing the SystemT3300 Diagnostic Ultrasound System |33 | B00601-010 4/10/174.2 Using the StandLift the stand to the degree that suits your preferred viewing angle. 4.3 Charging the SystemThe system is only partially charged when first unpacked. Charge the battery fully for 5 hours beforeusing the system for the first time. WARNINGS• Use only the supplied power adapter and AC plugs for charging.• AC plug and electric outlet types vary by country/region .• Do not try to repair or replace the battery or the power adapter. Any attempt todisassemble the system and the supplied accessories may cause damage to the systemor result in personal injury.1. Lift the protective rubber cover open.2. Connect the power adapter’s connector into the system’s power input socket.3. Insert the matching AC plug fully into the power adapter.4. Plug the AC plug of your power adapter into an electric outlet to start charging. The batteryindicator lights up in solid orange.WARNINGS
Preparing the SystemT3300 Diagnostic Ultrasound System |34 | B00601-010 4/10/17• Keep good ventilation during charging. Do not cover the power adapter with paper orobjects that will reduce cooling.• Do not interrupt the connection during charging to avoid possible damage.4.4 Installing the Transducer Holder1. Use your fingertip to remove the protective rubber covers from the rear side of the system. 2. Align the hole on the transducer holder with the hole patterns of the system.3. Rotate the screw clockwise through the upper hole of the transducer holder to tighten thetransducer holder to the system.
Preparing the SystemT3300 Diagnostic Ultrasound System |35 | B00601-010 4/10/174.5 Connecting the Transducer1. Flip the transducer cover open and insert the transducer carefully into the transducerconnection socket until it is locked in place. 2. Place the transducer in the transducer holder and ensure that the cable hangs down smoothlyfrom the opening of the transducer holder.
Preparing the SystemT3300 Diagnostic Ultrasound System |36 | B00601-010 4/10/174.6 Removing the TransducerPress and hold the release latch, and carefully pull out the transducer.
Preparing the SystemT3300 Diagnostic Ultrasound System |37 | B00601-010 4/10/174.7 Using the System On The Go1. Lift the stand by 180 degrees.2. Use the stand as a handle to carry the system around.3. To release the handle from 180 degrees, apply a pulling force to overcome the resistance in themagnetic field.
Preparing the SystemT3300 Diagnostic Ultrasound System |38 | B00601-010 4/10/174.8 Wall-mounting Your TabletThe hole pattern on the rear side of the tablet is compliant with VESA (75mm x 75mm/100mm x100mm) standard. Therefore, you can install your system on any VESA wall mounts or desktopmounts.1. Rotate the fixed screw clockwise on the rear side of the stand to fix the stand firmly onto thetablet.NOTETo facilitate your operation without scratching the touch screen, lay the system face-down on acushioned surface before fixing the stand. 2. Position the system precisely to the front of the mount plate where the hole patterns on both theback of the system and the plate meet.
Preparing the SystemT3300 Diagnostic Ultrasound System |39 | B00601-010 4/10/173. Secure the system to the mounting plate by carefully tightening the four screws using a suitablescrewdriver. NOTEWall-mounting is suggested to be operated by two people.4.9 Outputting the System Display to an HDMI-Enabled TV or Monitor1. Insert one end of an HDMI cable to the system’s HDMI port. Ensure that the arrow side faces up.2. Insert the other end of the HDMI cable to your HDMI-enabled TV’s or monitor’s HDMI port.3. Connect the TV or monitor to power.4. On the TV or monitor, select the proper input source.NOTES• We suggest using a monitor or TV which supports 1080p (1920x1080) resolution as an externaldisplay for your system.• See the documentation of your HDMI-enabled TV or monitor for detailed information onconnections and settings.
T3300 Diagnostic Ultrasound System |40 | B00601-010 4/10/17CHAPTER5Using the SystemBefore performing an ultrasound exam, understand and learn the featuresof the system. This chapter covers the following topics:•"Turning On/Off the System" on page 41•"Launching the Main Screen" on page 41•"Setting the System Time and Date" on page 42•"Controlling the System" on page 43•"Setting the System Language" on page 45•"Identifying the Main Screen Layout" on page 45•"Switching the Control Panel Pages" on page 52•"Managing the System Power" on page 52•"Managing Disk Space" on page 53•"Network Configuration" on page 54•"DICOM Configuration" on page 55•"Casting the System Screen to an External Display" on page 57
Using the SystemT3300 Diagnostic Ultrasound System |41 | B00601-010 4/10/175.1 Turning On/Off the SystemPress and hold the Power button to turn on the system. The system enters the main screen aftersystem startup.Press and hold the Power button until the Power off menu appears on the screen, then touch OK toturn off the system.NOTES• If the system is turned off abnormally, powering on the system the next time will take longer thanusual for a system hardware check.• If the system does not respond to any operations, press and hold the Power button to forcefullyturn off the system.• As the number of files saved in the system storage increases, the time it takes to power on thesystem will take longer than before. Consider backing up files and freeing up disk spaceregularly or when you are informed to do so (See "Managing Disk Space" on page 53).WARNINGIf an error message occurs after system startup, follow the on-screen instructions to fix theproblem. If the problem persists, contact technical support (See "Contact Information" onpage 2)5.2 Launching the Main ScreenAfter turning on the system, one of the following main screens appears.• If no transducer is connected, the system enters the system menu screen.No probe is connectedPatientWorklistExam HistoryReportPresetReviewSettings
Using the SystemT3300 Diagnostic Ultrasound System |42 | B00601-010 4/10/17• If a transducer is connected, the system enters the real-time B-mode imaging screen (default).NOTES• If a transducer is connected and the system displays the message “No probe is connected”,remove then re-connect the transducer. If the system still cannot detect the transducer, turn offthe system. Wait for a few seconds and restart the system.• You can choose the screen to enter after starting and logging in the system (with the transducerconnected). Go to > Settings > Workflow > Screen after Enter Ultrasound.5.3 Setting the System Time and DateManaging pertinent patient data and scanning results require accurate system time and date. Afterentering the system for the first time, set current time and date based on your location. The systemthen maintains time and date settings even when the system is turned off and disconnected frompower.1. Touch anywhere on the system toolbar to open the Quick Setup menu (See page 50).2. Touch the Time section > Set date/Set time.– To set the date, scroll to select the date, month and year.– To set the time, scroll to select the hours, minutes, and AM or PM.3. Touch Done. Touch to leave the setting.NOTECheck and correct current system time and date based on your location every month to ensure theaccuracy.End Exam Penetration General Resolution FreezeSaveColor PWMPowerBTHI Full ScreenFocusDepthGainBAbdomenFn Key Tuning TGC Home
Using the SystemT3300 Diagnostic Ultrasound System |43 | B00601-010 4/10/175.4 Controlling the SystemThe system requires operations with multi-touch controls by finger movements called gestures.Alternatively, you can add pointing or input devices by connecting them to the USB ports on thesystem.Table 1 GesturesTouch Touch and Hold DragDouble-Tap Press and Tap Two-Finger TapFlick Pinch Spreadx2
Using the SystemT3300 Diagnostic Ultrasound System |44 | B00601-010 4/10/175.4.1 Gestures for Controlling the Real-time/Frozen Imaging Screens5.4.2 Gestures for Controlling the Real-time Imaging ScreenTable 2 Gestures for Controlling the Real-time/Frozen Imaging ScreensAction GestureToggle between Real-time and frozen imaging screensDouble-tap on the scan area.To use this gesture, go to > Settings > General > (Enable freeze gesture) > Yes.Save a single image/cine loop(Available in full screen mode only)• Touch and hold on the scan area of the real-time/frozen imagingscreens to save a cine loop/single image.• On the frozen imaging screen, two-finger tap on the scan area toplay an image loop, then touch and hold on the scan area tosave the image loop.Zoom/unzoom Spread two fingers apart/pinch two fingers together.Move the zoomed image Touch and hold the zoomed image until the navigation button appear, then drag to move the image.Move and resize ROI Touch inside the ROI and drag to move it. Touch on the four corners of the ROI and drag to resize it.Move the BDMK/annotatioN/Arrow indicators Touch and hold the indicator, and drag to move it.Scroll the thumbnail list Flick vertically on the thumbnail area to scroll through the thumbnail list.Display the second control panel page/Return to the first control panel pageOn the control panel area, flick up to display the next page, flick down to return to the previous page (See "Switching the Control Panel Pages" on page 52).Table 3 Gestures for Controlling the Real-time Imaging ScreenAction GestureAdjust depth Flick vertically on the scan area to increase (flick down) or decrease (flick up) depth.Adjust gain Flick horizontally on the scan area/time series window to increase (flick right) or decrease gain (flick left).Adjust the sample volume size 1. Touch and hold one finger on the Spectral Doppler cursor.2. Flick another finger up or down.Move the Spectral Doppler cursor/sample volume• Touch the Spectral Doppler cursor and drag it horizontally.• Touch the sample volume and drag it vertically.Adjust the PW/CW correction angle 1. Touch and hold one finger on the Spectral Doppler cursor.2. Flick another finger to the left or right.Adjust the PW/CW baseline 1. Touch and hold on the baseline.2. Flick vertically to change the baseline position.
Using the SystemT3300 Diagnostic Ultrasound System |45 | B00601-010 4/10/175.4.3 Gestures for Controlling the Frozen Imaging Screen5.5 Setting the System LanguageTo set the system language you are using, touch > Settings > General > Language. Thesystem reboots automatically to enable the new language.NOTEIf you are unsure of a function displayed in localized languages, switch the system language back toEnglish, and check again the function you want to use. If the problem persists, contact technicalsupport (See "Contact Information" on page 2)5.6 Identifying the Main Screen Layout5.6.1 System Menu ScreenTouch to display the following system menu screen. Touch an icon to perform its function.Table 4 Gestures for Controlling the Frozen Imaging ScreenAction GesturePlay/pause image loops (Available in full screen mode only) Two-finger tap on the scan area.Scroll frames (Available in full screen mode only) Flick horizontally on the scan area/time series window to scroll through the image frames/waveforms.Table 5 Function and Description of System MenuNO. Function DescriptionPatient Edit current or add new patient information.Worklist Load the DICOM Modality Worklist (MWL) that contains patient information as well as the requested procedure electronically via the MWL query.PatientWorklistExam HistoryReportPresetReviewSettings
Using the SystemT3300 Diagnostic Ultrasound System |46 | B00601-010 4/10/175.6.2 Imaging Screen (Real-time)With the transducer connected correctly, the system enters the real-time imaging screen each timeafter pressing the Home button.Exam History View a list of patients with their exam results. You can proceed with unfinished exams/reviews, or export exams according to the selection criteria all at once.Report Display exam information including patient data, exam type, study specific data, comments and saved ultrasound images.Preset Select the predefined preset compatible with the connected transducer for optimized image control settings.Review View, add annotations and measurements to, and export a saved exam.Settings• Customize the system based on the operator’s habitual needs.• Use the service tools to update software, backup/restore data orexamine the system functionality. (See "Servicing your system" onpage 90)Table 5 Function and Description of System MenuNO. Function DescriptionTable 6 Real-time ImagingNo. FunctionSystem menu buttonEnter the system menu screen.Depth scaleTransducerMITISEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeColor PWMPowerBTHI Full ScreenFocusDepthGainB
Using the SystemT3300 Diagnostic Ultrasound System |47 | B00601-010 4/10/17Patient namePatient IDTransducer orientation icon (See page 62)Patient age/gender/DOB (date of birth)Application nameInstitution nameGrayscale/Color/Power wedgeScan Properties DisplayDisplay information about the current scan.Current date and timeSystem toolbar Display information about current battery level, volume, system storage, and network connection status. Touch anywhere on the system toolbar to open the Quick Setup menu for system configuration. (See page 50)Scan mode (image control) buttonsWhen using duplex or triplex modes, touch the scan mode (image control) buttons here to display and adjust its corresponding image control settings - .Image control settings (See page 79)Scan mode buttonsOpen the next/previous page of the image control settings (See page 44).Freeze buttonFreeze the current scan.Save button*Save a default set of image frames as a loop to the system hard drive.ROI (region of interest) areaUse the Zoom function to zoom in and pan across the current image.Home buttonReturn to the real-time imaging screen in B-Mode.TGC (Time Gain Compensation)Slide any of the 8 TGC sliders to adjust the gain for the desired section of the 2D image.Tuning buttonTouch this button to enable optimizing the image quality during a real-time scan. To turn it off, press and hold the button.Fn Key buttonAssign this button as a shortcut to perform a function.Table 6 Real-time ImagingNo. Function
Using the SystemT3300 Diagnostic Ultrasound System |48 | B00601-010 4/10/17*The system does not allow acquiring images/loops with no patient name and ID. A patient name/IDwill be added automatically if you proceed with saving.5.6.3 Imaging Screen (Frozen)During an exam, touch Freeze to review all the ultrasound images stored in the cine buffer frame byframe, or play back these frames in a continuous loop. You can also measure, calculate and addannotations to the frozen images or loops.Ultrasound imaging areaDisplay the 2D imaging window in all scan modes. By default, the top area is close to the region located near the transducer surface (near field). When scanning in M-Mode/PW Doppler/Triplex modes, the Time Series window displays under the 2D imaging window. The time increases from left to right and re-starts from the left again. The imaging area displays as common usage.•Resolution (High Resolution): Touch this button to view a clearer yet superficialimage.•General (General Resolution): Touch this button to view a general resolution image.•Penetration (Deep Penetration): Touch this button to view a deeper yet less clearimage.End Exam buttonClose the current exam for the current patient, and start a new exam for the next patient. All the value settings adjusted during this exam will be stored automatically.Thumbnail areaThumbnails of the scanned images/loops that are saved. Flick vertically to scroll through the list.Table 6 Real-time ImagingNo. FunctionControl panelControl panelSet start Set endPlayBDMKArrowLabelAnnotIMTCalcAngleTraceEllipseDepthDistanceErase AnnotErase MeasureTransducerMITISEnd Exam FreezeSaveFn Key HomeB
Using the SystemT3300 Diagnostic Ultrasound System |49 | B00601-010 4/10/17Table 7 Frozen ImagingNo. FunctionPerform measurements and calculations on the current image.Add annotations, including arrows, texts and body marks, to the current image using the Virtual Keyboard.Play buttonReview the image loop just scanned. Touch repeatedly to start/pause the playback.Freeze button (Enabled)Touch this button again to return to the realtime scan.Save buttonSave a frozen image from an image loop to the system hard drive.Open the next/previous page of the image control settings. (See page 52)Home buttonReturn to the real-time imaging screen.Set End buttonDuring playback of the image loop, touch this button to set the end point of the image loop.Set Start buttonDuring playback of the image loop, touch this button to set the start point of the image loop.The progress barUsed to track the frames (in a continuous image loop) just scanned and the number of the current frame.Image loop.This image is added to a report.
Using the SystemT3300 Diagnostic Ultrasound System |50 | B00601-010 4/10/175.6.4 Quick SetupTouch anywhere on the system toolbar to open the Quick Setup menu. Touch an item to adjust itssetting.Table 8 Quick SetupNo. FunctionManage the LAN connection. (See page 54)• : LAN Disconnected• : LAN ConnectedEnable/disable the WiFi function. (See page 54)Enable/disable the Bluetooth function. (See page 55)Cast the system screen to an external display. (See page 57)Display the percentage of the system storage used. (See page 53)• : Storage usage empty• : Storage usage fullCheck and manage outgoing queues to the DICOM server. (See page 55)• : DICOM Disconnected• : DICOM ConnectedSet current date and time. (See page 42)Adjust the volume.Adjust the brightness. creenPWSystemtoolbarLAN ConnectedWifi OFFBluetoothCast DisplayStorage UsageDICOMTimeOFFOFF89%ON4:40 PMQuick SetupEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeAbdomen
Using the SystemT3300 Diagnostic Ultrasound System |51 | B00601-010 4/10/175.6.5 Virtual KeyboardWhenever you need to enter text in a text field, simply touch the field, and a virtual keyboard appearson the lower part of the screen. Touch a letter to enter text; when finishing inputs, touch anywhere onthe imaging area.NOTETo switch the keyboard input language, touch on the virtual keyboard and select your targetlanguage.5.6.6 Scan Properties DisplayThe imaging window includes a text display information about the current scan.Table 9 Scan Properties DisplayNo. FunctionTransducer typeThermal index/Mechanical indexDepending on the transducer connected and the scan mode selected, corresponding scan parameters are displayed. (See "Using Image Controls" on page 78)Color/Power wedgeGrayscale wedge
Using the SystemT3300 Diagnostic Ultrasound System |52 | B00601-010 4/10/175.7 Switching the Control Panel PagesUse the virtual buttons or gestures to switch the control panel pages.NOTEThe functions available on the control panel vary, depending on the scan mode and the transducerconnected.• Use button:• Use gestures:5.8 Managing the System PowerThe system receives its power from the power adapter whenever it is connected to the system andstarts charging the battery, unless the battery is fully charged already. Battery remains chargingeven when the system is turned off, as long as the adapter is connected to the system and to ACpower. The system can also operate on battery power. The battery status icon (See page 53) alongwith the percentage of battery power remaining are shown on the system toolbar (See page 50).Always monitor the power level of the battery when you operate the system on battery power.Touch to switch between control panel pagesAbdomenEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeColor PWMPowerBTHI Full ScreenFocusDepthGainBEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeColor PWMPowerBTHI Full ScreenFocusDepthGainBAbdomen
Using the SystemT3300 Diagnostic Ultrasound System |53 | B00601-010 4/10/175.8.1 Battery Status IconsThe battery level is indicated by icons shown on the system toolbar.NOTEWhen the battery level reaches a critically low state, the system shuts down automatically.5.8.2 Sleep ModeSleep mode is a low-power mode that conserves battery power and allows quick startup of thesystem.It should be used only for short periods of time, such as when you transport the systembetween exam locations.To enter/exit Sleep mode, press the Power button.5.9 Managing Disk SpaceAlways beware of the amount of free space in the system storage. If the disk space on the systemdrive is full, the system cannot acquire images. To check the system storage used, open the QuickSetup menu and watch the number of percentage next to Storage Usage.The system sends warning messages when its available disk space reaches any of the followinglevel:•The image storage is low: The disk space available for storing images is low. Delete somestored exams to ensure that there will be enough room for new images.Table 10 Battery statusBatterystatus icon MeaningThe battery is fully charged.The battery is 80% to 99% charged.The battery is 60% to 79% charged.The battery is 40% to 59% charged.The battery is 20% to 39% charged.The battery is critically low.The battery is charging.The battery cannot be identified.Battery temperature is too high or too low and the battery stops charging.
Using the SystemT3300 Diagnostic Ultrasound System |54 | B00601-010 4/10/17•The image storage extremely low: The disk space available for storing images is critically low.Immediately delete some stored exams to free up your disk space.•The image storage is full: No disk space is available and no images can be saved. You mustdelete stored exams in order to have space for acquiring new images.To free up storage space, go to > Settings > Exam, and delete stored exams beforeselected number of weeks. Please back up required patient information before deletion. Deletion willremove the information from the system.5.10 Network ConfigurationThe system network is configured from the Quick Setup menu (See page 50). The configurationinformation for the system includes the IP address, port number, and other attributes required fortransmitting images and other study data across a network. The system network must be configuredbefore you use either the standard network support or the capabilities available through the DICOMnetworking options.5.10.1 Connecting the System to the Network by Ethernet1. Connect one end of the network connection cable to the wall receptacle for your network.2. Connect the other end of the cable to the Ethernet socket on the system.3. On the imaging screen, open the Quick Setup menu (See page 50).4. Touch LAN to go to Ethernet settings.5. Check Ethernet to enable the Ethernet function. If your system does not use Dynamic HostConfiguration Protocol (DHCP) to specify the addresses of domain name servers, continue tothe next step.6. Touch Ethernet configuration. Touch Static IP and configure the DNS settings.NOTEConsult your network administrator about the appropriate settings.7. Touch Save. Touch to leave the setting. If the connection is successful, appears on thesystem toolbar.5.10.2 Connecting the System to the Wireless NetworkNOTES• Wireless connection quality can be affected by many factors. The system may experience aconnection interruption while a network job is in progress. If this occurs, the job remains in thejob queue. When the connection is restored, the system resumes the job automatically.• The system supports the following wireless security standard: WEP, WPA/WPA2 and WPS. It isyour responsibility to configure the wireless network security mechanisms that are compatiblewith your network.1. Perform either of the following operations to go to the wireless network settings:– Touch > Settings > Networking > Wifi Configurations > ON.– Open Quick Setup menu (See page 50). Touch Wifi to go to Wifi settings.2. On the available network list, select an access point on an existing wireless network with yourDICOM server, and enter the required settings.
Using the SystemT3300 Diagnostic Ultrasound System |55 | B00601-010 4/10/17NOTEConsult your network administrator about the appropriate settings.3. Touch to leave the settings. If the connection is successful, appears on the systemtoolbar indicating the network strength.5.10.3 Connecting the System to a Bluetooth DeviceYou can connect the system to another pointing or input device via Bluetooth.NOTES• Using features requiring a Bluetooth connection may consume more battery power.• To extend battery life between charges, turn off Bluetooth when not using it.• Maximum distance between two connected Bluetooth devices cannot exceed 5 meters.1. Open the Quick Setup menu (See page 50).2. Touch Bluetooth to go to Bluetooth settings.3. The system scans for and displays the IDs of available Bluetooth devices within range.4. Touch the ID of the Bluetooth device to pair with it.5. Confirm the passkey that appears and touch Pair. On the other Bluetooth device, accept theidentical passkey for pairing.6. Touch to leave the settings. Once your system pairs with the device, appears on thesystem toolbar, and they stay paired until you unpair them.5.10.4 Unpair a Bluetooth DeviceTouch beside the connected device you want to unpair, and touch Unpair.5.11 DICOM ConfigurationThe system conforms to the Digital Imaging and Communications in Medicine (DICOM) standard.DICOM format is used for patient studies that are transferred among PACS, which make up ahospital information management system, and for studies that are accessed by physicians at remoteviewing stations.The DICOM networking option settings are usually obtained from a network administrator.NOTEBefore DICOM configuration, ensure that the system is successfully connected to a wireless orwired network.To configure DICOM settings, touch > Settings > DICOM.5.11.1 Adding Servers1. Select a storage/worklist SCP (Service Class Provider) and touch Edit.–Storage SCP: Used to take responsibility for and provide receipt of content sent by the system.–Worklist SCP: Contain scheduled patient procedure data and is used to import the data into the patient information form.2. Assign a name to the server and enter it in the Name field.
Using the SystemT3300 Diagnostic Ultrasound System |56 | B00601-010 4/10/173. Enter the IP Address,Port and AE Title specified by your network administrator in therespective fields.4. To test the server connection, touch Test in the Echo Test section. A verification messageconfirms a successful connection within a few seconds.NOTES• To start exams by loading patient information in a worklist, you need to configure the worklistSCP first.• Consult your network administrator about the appropriate settings.5.11.2 Local HostIn the Local Host section, touch Edit.The system’s default Name and IP Address, if connected successfully to the network, display in therespective fields.In the AE Title field, enter the application entity title of your system, which identifies you as thesender and must be unique on its network.NOTEConsult your network administrator about the appropriate settings.5.11.3 Managing Outgoing QueueWhen you export an exam or an image/video to the DICOM server, you can monitor its status on theupper right side of the imaging screen or in the outgoing queue (from > Settings > DICOM>(Outgoing Queue) > Edit). The system provides three ways of exporting the exam. For moreinformation, see "Exporting the Exam" on page 75. *If you export the report to the DICOM server, the task status icon includes .In the Outgoing Queue section, touch Edit.• To re-send the task to the DICOM server, touch Retry.• To cancel the ongoing task, touch Stop.• To clear all tasks from the outgoing queue, touch Clear all history.Table 11 Task statusTask status icon* DescriptionUpload is pending.Upload is processing.Upload is complete.Upload failed.
Using the SystemT3300 Diagnostic Ultrasound System |57 | B00601-010 4/10/175.12 Casting the System Screen to an External DisplayYou can cast your system screen which allows you to mirror your system to a monitor or TV thatsupports wireless display function.1. On your system, open the Quick Setup menu (See page 50). Touch Wifi to enable the wirelessnetwork function. Then touch Cast Display Off to go to its settings.2. On the top right corner of the system screen, touch and check Enable wireless display to see your available wireless display devices in a list. Touch the device to connect to.3. On the display device, follow the on-screen instructions to give permission for connection fromand to the system.4. If connected successfully, the device name on the system screen shows “Connected”. Thecontents shown on the system screen are mirrored to the display device screen automatically.NOTETo disable the casting display function: On the system, open the Quick Setup menu and touch Cast Display Off > the device name >Forget.
T3300 Diagnostic Ultrasound System |58 | B00601-010 4/10/17CHAPTER6Performing an ExamTo perform an exam, complete the general procedure:1. Start an exam. It can be a new exam, or a previously saved/pausedexam.– To start a new patient exam, add a new patient (See page 59).– To load a work list (See page 60).– To resume a previously saved/paused exam (See page 75).2. Select an exam type and preset (See page 60).3. Start real-time imaging (Imaging Screen (Real-time)).4. Set the transducer orientation (See page 62).5. Select a scan mode (See page 62) and adjust image controls (Seepage 78).6. When the desired anatomy is shown, freeze the image (ImagingScreen (Frozen)).7. Add annotations (See page 65) and measurements (See page 68).8. Save or print the image (See page 72).9. (Optional) Review the images (See page 72), generate a report andexport the exam (See page 75).10. End the exam (See page 77).Refer to the following sections for detailed instructions.
Performing an ExamT3300 Diagnostic Ultrasound System |59 | B00601-010 4/10/176.1 Starting a New ExamThe system allows skipping entering patient information if you need to start the ultrasound examimmediately. You can enter the Patient screen to complete the patient information during or after theexam. However, once you touch Save to save images/cine loops, the system will add a last name/IDto the patient automatically, and the last name/ID cannot be modified.NOTETo avoid confusion and to generate reports, define the patient within the system before scanning.6.2 Adding a New Patient1. On the imaging screen, touch > Patient.2. Touch New Patient. Enter the patient information as much detailed as possible:– Touch in a text entry field, and use the virtual keyboard to input contents.–Touch Next on the keyboard to go to the next field.–Touch Done on the keyboard. The patient information is saved automatically.NOTETo create a valid patient profile, at least the patient’s Last Name and ID number should be filled in.3. To start scanning the patient, touch Start Exam.6.2.1 Updating Patient Information1. During real-time scanning, touch > Patient. Existing information of the current patientdisplays on the Patient screen.2. Enter the new information in the desired fields.3. The patient information is saved automatically. Proceed with real-time scanning of this patient bytouching Start Exam.PatientNew PatientStart ExamPatient InformationLast Name Middle Name First NameID Gender DOB AgeAbdomen Cardiology GYN OB Small Part Urology VascularHeight Weight BSAExam InformationHeart Rate bpmkgmmHgBlood Presscm m2Accession Institution OperatorReferring Physician Interpreting PhysicianDescriptionCommentHome Previous End Exam
Performing an ExamT3300 Diagnostic Ultrasound System |60 | B00601-010 4/10/176.3 Loading a WorklistThe system conforms with the Digital Imaging and Communications in Medicine (DICOM) standard,which is the industrial standard for the communication and management of patient data betweendevices in the hospital. You can load patient information in a worklist via the DICOM server.NOTEFor more information on configuring DICOM settings, see "DICOM Configuration" on page 55.1. On the imaging screen, touch > Worklist.2. Select the number of patients to scan on the worklist from the drop-down menu.3. Select a patient, then touch Start Exam to start scanning.NOTETo scan patients following a specific rule, enter the query criteria in any of the Name / ID /Accession# fields, and touch Query to start the query. Patients matching the query criteria will belisted on the screen.6.4 Selecting a PresetThe system provides predefined presets for all supported transducers. Choosing an exam loadsoptimized presets for image control settings, based on the anatomy to be scanned, the transducerused, and the scan mode. The presets also specify the measurements appropriate for the exams.20Start ExamHome PreviousWorkList Query WorklistName IDAccession# DateQuery ClearWorklist: 0recordsName ID Accession# Gender DOBQuery
Performing an ExamT3300 Diagnostic Ultrasound System |61 | B00601-010 4/10/17You can directly use the optimized presets, or adjust any of the image control settings as necessaryfor the specific patient and the specific exam.1. On the imaging screen, touch > Preset. All the available presets compatible with theconnected transducer display on the Preset screen. 2. Touch the preset to scan, and you will be redirected automatically to the real-time imagingscreen.6.4.1 Customizing a Preset1. On the Preset screen, touch Create New.2. Enter a name for the customized (currently used) preset and touch Save.6.4.2 Modifying a PresetIf you have modified the parameters of an existing customized preset, go to the Preset screen andtouch Modify Current to save changes.6.4.3 Managing Presets1. On the Preset screen, touch Management.• Touch Move, and drag to re-arrange the order of the presets.• To set a frequently used preset as default, touch Set default > the desired preset.• To hide an unwanted predefined preset, touch Hide & Show and touch Off on the preset. • To further edit customized presets, touch Edit and touch on the preset to edit its name;touch on the unwanted preset to delete it.2. Touch Save to save changes.6.4.4 Exporting and Importing Customized PresetsOn the Preset screen, touch Export/Import to export/import customized presets to/from yourexternal storage.GYNPreset Select PresetCreate NewManagementExportImport Abdomen OB RenalUrologyCustom1 Custom2Home PreviousDefault presetCurrently used presetPredefined presetsCustomized presets
Performing an ExamT3300 Diagnostic Ultrasound System |62 | B00601-010 4/10/176.5 Setting the Transducer OrientationUpon entering all scan modes, the orientation marker displays at the default location (usually atthe top left side of the image), and suggests you the direction of holding the transducer. Theorientation marker on the screen corresponds to the position of the orientation marking on the sideof the transducer. You can change the left/right orientation of the image (real-time or frozen) in various imaging (singleor dual) without rotating the transducer head itself.• To reverse left and rightOn the imaging screen (real-time or frozen), touch > L/R.• To reverse up and downOn the imaging screen (real-time or frozen), touch > U/D.6.6 Selecting/Switching a Scan ModeOn the real-time imaging screen, directly touch the scan mode buttons on the control panel to select/switch the scan mode in use.NOTETo view a list of available scan modes, see "Imaging" on page 24.6.7 Adjusting the Displayed ImageOn the real-time imaging screen, touch the corresponding scan mode (image control) button toselect a scan mode. Use the image control settings to further optimize the image. (See "Using ImageControls" on page 78)You can also perform the following operations to adjust the contents of the imaging window.Orientation marker
Performing an ExamT3300 Diagnostic Ultrasound System |63 | B00601-010 4/10/176.7.1 Enlarging an Area of the ImageTo further examine the anatomy by enlarging a region of the image (real-time or frozen), use thezoom function.1. On the real-time imaging screen, touch > Zoom, or on the frozen imaging screen, touch >Zoom. The ROI (Region of Interest) box appears on the center of the image. Touch and drag inside of the ROI box to move it to the area to enlarge. Touch on any of the box’sfour corners and drag to resize the ROI box.2. Touch anywhere outside the ROI box to enlarge the selected area.3. To move the enlarged area, touch and hold anywhere on the image until the navigation buttonappear, then drag to move it.6.7.2 Splitting the Imaging ScreenThe system allows splitting the imaging screen into two sections to view two current scans for apatient. You can acquire one scan for the patient, enable dual screen, then acquire another scanfrom a different angle, location or with a different scan mode. This function is only available in B,B+Color and B+Power modes.6.7.2.1 When in B-Mode:On the real-time imaging screen, touch Dual. The system immediately freezes the current scan, andcopies the current settings for the image to the second screen. Two yellow bars will be added to theEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeBDyn RangePersistQScanGray MapChromaDualToggleL/RU/DSteeringAbdomenZoomDensityHighROI boxEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeBDyn RangePersistQScanGray MapChromaDualToggleL/RU/DSteeringZoomDensityHighAbdomenZoom View :3.3X
Performing an ExamT3300 Diagnostic Ultrasound System |64 | B00601-010 4/10/17top/bottom of the currently active screen. To toggle between screens, touch Toggle. Only onescreen can be active at a time. You can compare then apply any image control settings and use scan modes independently to eitherscreen. For example, you can acquire a 2D scan, activate dual screen, then acquire a Color scan inthe second screen.6.7.2.2 When in B+Color or B+Power Mode:On the real-time imaging screen, touch Dual. The system copies the current settings for the imageto the second screen in B-mode. Both screens are in real-time but you get a clearer view under theROI in B-mode. Touching Dual again freezes the 2D real-time scan and turns it into a frozen B+Color or B+Powermode image.To leave the dual screen, touch Dual, or touch Home to return to the real-time B-mode.NOTETo enable dual screen when the scan is frozen, touch > Compare.End Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeBDyn RangePersistQScanGray MapChromaDualToggleL/RU/DSteeringZoomDensityHighAbdomenEnd Exam Penetration General Resolution FreezeSaveFn Key Tuning TGC HomeColorPersistColor MapWall FilterDualToggleL/RU/DZoomDensityMedRenalBSmoothingReject
Performing an ExamT3300 Diagnostic Ultrasound System |65 | B00601-010 4/10/176.8 Freezing an ImageDuring a real-time scan, touch Freeze to freeze live ultrasound images recorded by frame andstored temporarily in the cine buffer. Depending on the mode selected, a certain number of framesare recorded.• To play back saved images in a continuous cine loop, touch Play.• To adjust the playback speed, touch > Loop Speed +/-.• To view the stored images frame by frame or to find a specific frame, touch / or dragthe frame indicator horizontally.NOTES• To restart a new real-time scan, touch Freeze again.• Restarting real-time scanning erases the frame data. Make sure any needed images are savedor printed before acquiring new scan data.• To change the screen to enter after you freeze the scan, on the system imaging screen, touch>Settings > Workflow > (Status after Freeze) > select an option.6.9 Adding AnnotationsOn the real-time or frozen imaging screen, touch Annot to add annotations to the ultrasound imagesin order to explain the anatomy.After you are done adding annotations, you can still move the annotated texts or arrows anytime bytouching and dragging them to your desired location.NOTEYou can select whether to keep or erase the annotations added after you return to the live scan bytouching > Settings > Workflow > (Auto-clear Annotation after Unfreeze) > select anoption.abcEnd Exam Set home Go homeDeleteLeft RightUpper LowerMedialAnteriorLateralPosteriorSAG TRANSPROX MIDLT KidneyLT LobeRT KidneyRT LobeAorta LiverCBD IVCDuodenumAppendixFluidPancreasGallbladderCaudateSpleenBowelAbdomen
Performing an ExamT3300 Diagnostic Ultrasound System |66 | B00601-010 4/10/176.9.1 ArrowTouch Arrow. An arrow appears at the text home position. Drag the arrow to the desired location,and release it to place the arrow .6.9.2 Annot6.9.2.1 Text1. Touch Annot. A virtual keyboard and a text cursor (I-beam) appear at the text home position.2. Type the texts directly. Touch anywhere on the imaging area to finish inputs.3. Drag the text cursor to where you want the new texts to be, and release it to place the texts .6.9.2.2 Setting the Text Home PositionYou can choose a specified position in the image display as the starting location, which is the texthome position.1. Drag a set of annotated texts to the desired text home position.2. Touch the texts directly, then touch to close the keyboard.3. Touch Set home.6.9.3 Label1. Touch Label. A predefined text menu appears at the control panel area , and a text cursor (I-beam) appears at the text home position.2. Select a text label to place it at the current cursor position, and touch Close.3. Drag the label to where you want the texts to be, and release it to place the label.NOTES• The annotated texts or text labels are still editable. Touch a set of texts to display the virtualkeyboard, and start editing the texts. Touch anywhere on the imaging area to finish editing.• To restore the annotated texts or text labels to the default text home position, simply touch a setof texts, touch to close the keyboard, then touch Go home.abc
Performing an ExamT3300 Diagnostic Ultrasound System |67 | B00601-010 4/10/176.9.4 Body Mark1. Touch BDMK to display the body mark menu.2. A pictogram of the default body mark with a transducer indicator displays on the image. If youwish to change the body mark, select one from the BDMK menu that appears, then touch Close.3. Touch anywhere on the image, and drag the transducer indicator to the desired location on thebody mark.4. Touch anywhere on the image and move to rotate the transducer indicator.5. Touch and hold the pictogram, and drag it to the desired location on the image.NOTES• You can change the default body mark by touching > Settings > BDMK >(DefaultBDMK for Application) > Edit > select an option.• To delete annotations, including texts and arrows, touch Erase Annot to erase the lastannotation added. Repeat this action, if needed, to continue erasing annotations.• To directly erase all annotations, touch and hold Erase Annot.• To delete the body mark added, touch BDMK > Erase.AbdomenEnd Exam Set start Set end Fn KeyClose EraseHome FreezeSaveTransducerindicator
Performing an ExamT3300 Diagnostic Ultrasound System |68 | B00601-010 4/10/17• To set whether to show all or the last annotations, or to hide them all, touch > Show Annot+/-.6.10 Adding MeasurementsMeasurements accompanying ultrasound images supplement other clinical procedures available tothe attending physician. You can perform as many measurements as needed.On the real-time imaging screen, touch Freeze to display a set of measurement buttons based onthe scan mode selected. To perform a single type of measurement, touch the corresponding button.To perform a set of predefined measurements from the Calculation Package, touch Calc (See"Calculation Package" on page 70).When you are measuring, the indicators/lines display in yellow, allowing you to adjust as many timesas needed. When you are done with measuring, use any of the following methods to complete themeasurement. The indicators/lines then turn green, and the final measured results (values) appearon the top left side of the imaging screen.• Two-finger tap on the scan area• Proceed with the next measurement•Touch Save to save the ultrasound imageNOTES• To re-position the measured results to the imaging screen’s Left Top,Left Bottom,Right Top,or Right Bottom side, touch > Result Pos +/-.• To set whether to show all or the last measured results, or to hide them all, touch > ShowResult +/-.• To delete measurements, touch Erase Measure to erase the last measurement added. Repeatthis action, if needed, to continue erasing measurements.• To directly erase all measurements, touch and hold Erase Measure.• You can select whether to keep or erase the measurements added after you return to the livescan by touching > Settings > Workflow > (Auto-clear Measurement after Unfreeze)> select an option.1 Distance 85.51 mm2 Depth 12.36 mm3 EllipseArea 438.49 mm2Circ 124.71 mm4 TraceArea 1939.68 mm2Circ 142.66 mm5 Angle 56.55 degree6 IMTMax 0.00 mmMin 0.00 mmAvg 0.00 mmStd 0.00 mm123456abcdefEnd Exam Set start Set end Fn Key Home FreezeSaveBAbdomenDistanceErase AnnotDepthEllipse TraceAngle CalcErase MeasureAnnot LabelArrow BDMKPlayIMT
Performing an ExamT3300 Diagnostic Ultrasound System |69 | B00601-010 4/10/176.10.1 Measuring in B/Color/Power Modes6.10.1.1 DistanceMeasure a distance.1. Touch Distance. A crosshair cursor appears on the image. Drag the target cursor to where youwant to start measuring and release it.2. Drag the target cursor to where you want to finish measuring, then release it .6.10.1.2 DepthMeasure depth.Touch Depth. A crosshair cursor appears on the image. Drag the target cursor to where you want tofinish measuring the depth, then release it .6.10.1.3 EllipseMeasure a circumference.1. Touch Ellipse. A crosshair cursor appears on the image. Drag the target cursor to one end of thearea you want to measure and release it to set the start point of measurement.2. Drag the target cursor to the other end of the desired area, and release it to set the end point ofmeasurement.3. Touch the center of the oval area and drag out to increase or drag in to decrease the size of thecircle .6.10.1.4 TraceManually trace an irregular shape.1. Touch Trace. A crosshair cursor appears on the image. Drag the cursor to where you want tostart measuring and release it. 2. Drag the cursor along the outline of the object to trace. 3. When the tracing is nearly done, release the cursor and the system completes the loop bydrawing a line from the current cursor position to the starting point .6.10.1.5 AngleMeasure an angle.1. Touch Angle. A crosshair cursor appears on the image. Drag the target cursor to the desiredlocation and release it to set the start point of measurement.2. Drag the first target cursor along one side of the desired area, and release it to draw the first line.3. Drag the second target cursor along the other side of the area, and release it to draw the secondline. The angle between the two lines is then formed .abcde
Performing an ExamT3300 Diagnostic Ultrasound System |70 | B00601-010 4/10/176.10.1.6 IMTMeasure IMT (Intima-Media Thickness) of the carotid artery, which is useful for detecting early signsof arteriosclerosis.1. Touch IMT. A crosshair cursor appears on the image. Drag the target cursor to the desiredlocation and release it to set the start point of measurement.2. Drag the target cursor to the other end of the desired area, and release it to set the end point ofmeasurement. The automatic tracing of the IMT will be enclosed and measured within therectangle area marked by the four corners .6.10.1.7 Calculation PackagePerform a set of predefined measurements based on the scan mode/calculation method you select.1. Touch Calc to open the Calculation Package menu.2. Touch a desired calculation method. The items to measure display in a list of order under theselected method.3. Touch the first item and the screen displays the corresponding cursor. Drag it to performmeasurement.4. After you have finished with the measurement, touch the second item. The first item is checkedautomatically with the measured result displayed beside it.5. Repeat step 3-4 to perform the rest of the measurements on the list, then touch Close.NOTESFor measurement accuracy and precision in 2D measurement:• Linear distance measurement errors will be less than ±5%.• Perimeter, and ellipse circumference measurement errors will be less than ±5%.• Area measurement errors are related to the linear distance measurement and will be less than±10%.6.10.2 Measuring in M-Mode6.10.2.1 DistanceMeasure the length between two horizontal lines that lean on two cursors. The position of the verticaltime lines does not affect the distance measurement.1. Touch Distance. A crosshair cursor with horizontal and vertical axes appears on the time serieswindow. Drag the cursor to a desired start point on the vertical axis and release it.2. A second cursor appears. Drag it to the end point on the vertical axis then release it to completemeasurement.6.10.2.2 SlopeMeasure the length between the intersections of two cursors. Slope can be positive or negative andmeasures the rate of change between the two points defined by the intersections of the cursors incm/sec.1. Touch Slope. A crosshair cursor with horizontal and vertical axes appears on the time serieswindow. Drag the cursor to a desired start point and release it.2. A second cursor appears. Drag it to the end point then release it to complete measurement.f
Performing an ExamT3300 Diagnostic Ultrasound System |71 | B00601-010 4/10/17NOTEThe slope measurement is not restricted to either the horizontal or the vertical axis of the startmarker.6.10.2.3 TimeMeasure the length between two vertical time lines created by two cursors. The position of thehorizontal distance lines does not affect time measurements.1. Touch Time. A crosshair cursor with horizontal and vertical axes appears on the time serieswindow. Drag the cursor to a desired start point on the horizontal axis and release it.2. A second cursor appears. Drag it to the end point on the horizontal axis then release it tocomplete measurement.6.10.2.4 Heart RateMeasure the length between two vertical lines created by two cursors in beat per minute (BPM). Theposition of the horizontal distance lines does not affect the heart rate.1. Touch Heart Rate. A crosshair cursor with horizontal and vertical axes appears on the timeseries window. Drag the cursor to a desired start point on the horizontal axis and release it.2. A second cursor appears. Drag it to the end point on the horizontal axis then release it tocomplete measurement.6.10.3 Measuring in Spectral Doppler ModeNOTEThe measured results of performing Trace, Semi-Trace and Auto Trace vary depending on thetransducer connected.6.10.3.1 VelocityMeasure the blood flow velocity.Touch Velocity. A crosshair cursor with vertical axis appears on the time series window. Drag thecursor to the measurement point, and release your finger to place it.6.10.3.2 TraceManually trace the Doppler spectrum.1. Touch Trace. A crosshair cursor with vertical axis appears on the time series window. Drag thecursor to a desired peak of the graph and release it.2. A second cursor appears. Drag the cursor along the waveform on the graph to end diastole thenrelease it.3. A third cursor appears. Drag it to the second peak of the graph and release it to complete thetrace.6.10.3.3 Auto TraceTrace the spectrum of Doppler waveforms.Touch Auto Trace. The trace for the Doppler spectrum will be performed automatically withmeasurements calculated and displayed on the screen.
Performing an ExamT3300 Diagnostic Ultrasound System |72 | B00601-010 4/10/176.10.3.4 Semi-TraceTrace the Doppler spectrum with better accuracy in the measurement calculation.1. Touch Semi Trace. A crosshair cursor with vertical axis appears on the time series window.Drag the cursor to a desired peak of the graph and release it.2. A second cursor appears. Drag it along the waveform to end diastole on the graph then releaseit.3. A third cursor appears. Drag it to the second peak of the graph and release it4. Touch anywhere on the imaging area to complete the trace.NOTETo obtain an accurate auto-trace and measurement result, a high-quality Spectral Doppler imagewith clean noise background is required.6.10.3.5 2-Points MeasurementUsed to perform a set of basic Spectral Doppler measurements which may include peak systolicvelocity, end diastole velocity, mean velocity, time, slope, pulsatility index, resistive index, systolic/diastolic ratio, pressure half-time and maximum pressure gradient, depending on the transducerconnected and the application selected.1. Touch 2 pt. Meas. A crosshair cursor with vertical axis appears on the time series window. Dragthe cursor to a desired peak of the graph and release it.2. A second cursor appears. Drag it to end diastole on the graph and release it. The measuredresults (values) appear on the screen.NOTEFor measurement accuracy and precision in PW Doppler measurement:Velocity measurement will be less than ±12%.6.11 Saving and Printing the ImageAfter adding annotations/measurements to the image, you can save or print the image.6.11.1 Saving an Image LoopOn the real-time imaging screen, touch Save to save a default set of frames as an image loop. Thesaved image loop will be displayed in the thumbnail list.6.11.2 Saving an ImageOn the frozen imaging screen, touch Save to save the current frame as an image. The saved imagewill be displayed in the thumbnail list.6.11.3 Printing an ImageOn the frozen imaging screen, touch Print to print out the current image. 6.12 Reviewing the ImageOn the frozen imaging screen, flick vertically on the thumbnail list to view the thumbnails of all thesaved images/loops.
Performing an ExamT3300 Diagnostic Ultrasound System |73 | B00601-010 4/10/17To further examine one or a set of images/loops, touch the thumbnail of the desired image or imageloop to display the Review screen.6.12.1 Performing Multiple SelectionsYou can perform actions to more than one image/loop at a time. 1. Touch Multi-Select +/-.2. Flick vertically on the thumbnail window and touch to select multiple images/loops as expected.– To quickly select all images, touch Select All.– To cancel all selections, touch Deselect All.3. Touch an action button. For example, touch Delete to delete all selected images/loops.End Exam Set start Set end Fn Key Home FreezeSaveBAdd to ReportAbdomenReportMulti-SelectMulti-CompareExam HistoryPrintPlayExport Exam DeleteAbdomen 3/1/20174.40 PM Abdomen 3/1/20174.40 PM Abdomen 3/1/20174.40 PMAbdomen 3/1/20174.40 PM Abdomen 3/1/20174.40 PM Cardiac 3/1/20174.40 PMCardiac 3/1/20174.40 PM Abdomen 3/1/20174.40 PMCardiac 3/1/20174.40 PMRR123End Exam Select AllFn Key Home FreezeSaveDeselect AllBAdd to Report ReportMulti-SelectMulti-CompareExam HistoryPrintPlayExport Exam Delete
Performing an ExamT3300 Diagnostic Ultrasound System |74 | B00601-010 4/10/176.12.2 Comparing ImagesYou can compare the scanned images/loops by displaying selected ones on the screen.1. Touch Multi-Compare +/-.2. Flick vertically on the thumbnail list, and touch to select up to 4 images/loops to display forcomparison.3. Touch an action button. For example, touch Delete to delete all selected images/loops.6.12.3 Generating a Report1. On the Review screen, touch the thumbnails of the desired images and touch Add to Report.2. Touch Report to display the following screen.3. Fill in information about the patient and the study, if not complete, and add comments using thevirtual keyboard.4. Flick down to review the images added, and add comments to individual images, if needed.NOTEYou can still add/remove images to/from the report without going back to the Review screen. TouchAdd Image to display the image editing screen. Check/uncheck the desired images and touch Addto Report.5. Touch Image Layout +/- to select the number of columns for placing the images on a report.31Abdomen 3/1/20174.40 PM2Fn KeyEnd Exam Home FreezeSaveBAdd to Report ReportMulti-SelectMulti-CompareExam HistoryPrintPlayExport Exam DeletePlease press thumbnail to add to review list Please press thumbnail to add to review listPlease press thumbnail to add to review listPatient informationStudy date: 3/1/2017 / Exam type: AbdomenPrevious End ExamExam HistoryExportHomeExam informationInstitution:Referring:Interpreting:Signature:TemplateName: ID: DOB:Age:Height cm Weight kg BSA m2Heart Rate bpmBlood Press mmHg1 columnAbdomenReportPrintPrint PreviewImage LayoutAdd ImageDelete Image
Performing an ExamT3300 Diagnostic Ultrasound System |75 | B00601-010 4/10/176. The system provides two ways of saving the report:– Ensure an external storage device is connected to the system, then touch Export. Select the file format and directory, enter the file name then touch Save as file.– Touch Export and select to export the report to the DICOM server.7. To print out the entire report with scanned images, first touch Print Preview to preview thereport, then touch Print.NOTEUse the buttons on the Print Preview screen to zoom in/out the report or select a preferred pagelayout style to view the report.To print out the report in texts only, touch One Page Report > Print.6.13 Exporting the ExamYou can export exams and images to an external storage or the DICOM server. When exporting anexam, an image or a cine loop, the system creates a uniquely named subdirectory for each exam,image or loop.1. The system provides two ways of exporting the exam:– On the Review screen, touch Export Exam.– On the Exam History screen, check the completed exams, and touch Export Exam.2. Select to export the exam in DICOM file format to the DICOM server, external storage ornetwork, or to export with common media formats to external storage or network.NOTES• To enable exporting an exam to DICOM automatically after ending the exam, touch >Settings > Workflow > (Export DICOM after End Exam) > Yes.• To configure DICOM settings, see "DICOM Configuration" on page 55.6.14 Managing the Exam HistoryYou can check and update status of all the stored exams from the Exam History screen.
Performing an ExamT3300 Diagnostic Ultrasound System |76 | B00601-010 4/10/17On the imaging screen, touch > Exam History. Refer to the Status column to check thestatus of each exam (See "Exam status" on page 76). To review images/video clips of an exam,touch ( ). Alternatively, you can enter the query in any of the Name/ID/Date fields, and touch Query () tostart the query. Patients matching the query will be listed on the screen. To clear all search criteria,touch Clear ().6.14.1 Resuming an ExamTo resume an exam, check the exam and touch Continue to enter real-time scanning.6.14.2 Starting a New ExamTo start a new exam from a patient with an existing exam, check the exam and touch NewExam.6.14.3 Finishing ExamsTo update the exam status as “Complete”, multi-check the exams and touch Complete.6.14.4 Deleting ExamsMulti-check the exams and touch Delete Exam to delete exams.Table 1 Exam statusExam status MeaningComplete Ended examProcessing Ongoing examPause Proceed to the next exam while leaving the currently ongoing exam not endedExam HistoryNew ExamContinue Exam HistoryNameHome PreviousCompleteDelete Exam Export ExamImportIDDateQuery ClearName ID Type Study Date Image StatusProcessingPauseCompleteExam Image & ClipSearch Exam
Performing an ExamT3300 Diagnostic Ultrasound System |77 | B00601-010 4/10/176.14.5 Exporting ExamsTo export exams, multi-check the exams , touch Export Exam and select an export method. Ifyou select to export to DICOM, the task status icons (See page 56) next to the checkboxes indicatethe uploaded results of the exams.6.14.6 Importing ExamsTo import exams from the connected external storage device, touch Import > select an import item.6.15 Ending the ExamAn exam is not complete if you proceed with a new exam without ending the previous one. To endthe exam, touch End Exam on the imaging screen. The exam will then be exported in DICOM fileformat to the DICOM server if you have enabled the Export DICOM after Exam feature (Seepage 89). If this feature is disabled, you will enter the Patient or Worklist screen or a new scan startsautomatically, based on your selection from > Settings > Workflow > (Screen after EndExam).After ending the exam, you can still save images/cine loops, add annotations, performmeasurements and modify the patient information within 24 hours, except the patient ID and thepatient’s last name. To do so, go to the Exam History screen, check the ended exam and touchContinue.NOTES• To export exams to the DICOM server, you need to configure the DICOM settings first. (See"DICOM Configuration" on page 55)• To check the exam status, touch > Exam History.(See "Managing the Exam History"on page 75)
T3300 Diagnostic Ultrasound System |78 | B00601-010 4/10/17CHAPTER7Using Image ControlsThis chapter covers the following topics:•"B-Mode Image Controls" on page 79•"Color/Power Mode Image Controls" on page 82•"M-Mode Image Controls" on page 83•"Spectral Doppler Mode Image Controls" on page 85All of the information in this chapter pertains to real-time imaging. Many ofthe controls and functions change when you freeze the scan. Forinformation on using functions when the scan is frozen, see "AddingAnnotations" on page 65 and "Adding Measurements" on page 68.
Using Image ControlsT3300 Diagnostic Ultrasound System |79 | B00601-010 4/10/17On the real-time imaging window:• Touch the scan mode (image control) buttons to select the scan mode (See "Imaging Screen(Real-time)" on page 46).• Touch / or use gestures to switch the control panel pages to go through the availablefunctions (See "Switching the Control Panel Pages" on page 52).7.1 B-Mode Image Controls7.1.1 OverviewThe system delivers 2-dimensional digital imaging (B-mode) using 256-level gray map. This scanmode delivers excellent image uniformity, tissue contrast resolution, and steering flexibility infrequencies from 2 MHz to 15 MHz. 7.1.2 Adjusting GainAdjust amplification of the returning echoes, which adjusts the amount of echo information displayedin an image. The overall brightness of the image can be elevated, but the “noise” may also be addedto the image with excessive increase in gain.Touch Gain +/- or flick horizontally on the scan area to adjust the gain value.7.1.3 Adjusting FrequencyChange the scan frequency to obtain higher resolution as frequency increases, or deeperpenetration as frequency decreases.To increase the frequency, touch Resolution. To decrease the frequency, touch Penetration.7.1.4 Adjusting Time Gain Compensation (TGC)Adjust the gain which compensates for the attenuation (a reduction in sound amplitude) of the echosignals in proportion to their depth (based on travel time).Touch TGC to display the TGC sliders on the screen. To increase/decrease the gain at the desiredsection (depth) of the image, drag the corresponding slider to the right/left.Save FreezeHomeTGCTuningResolutionGeneralPenetrationEnd ExamAbdomenGainDepthFocusTHI Full ScreenBColor PWMPowerB2D mode(B-mode)imageinformationFn Key
Using Image ControlsT3300 Diagnostic Ultrasound System |80 | B00601-010 4/10/177.1.5 Adjusting the Scan DepthAdjust the field of view. To view larger or deeper structures, increase the depth. To enlarge thedisplay of structures near the skin line, decrease the depth. The system automatically adjusts theframe rate (FPS) and acoustic power indices (TI/MI) based on the scan depth.Touch Depth +/- or flick vertically on the scan area to set the scan depth.7.1.6 Adjusting the Focus Depth, Focal Zone and Focal spanFocus optimizes the image by increasing the resolution for a specific area and is displayed by a redarrow marker indicated at the depth ruler. Depending on the transducer in use and the modeselected, multiple focus depths can be added. Increasing the number of focal zones decreases theframe rate. If the frame rate is not high enough, try decreasing the number of focal zones.Touch Focus +/- to adjust the depth value. Touch Focal Zone +/- to select the desired number offocal zones. Touch Focal Span +/- to adjust the distance between the focal zones.7.1.7 Adjusting Dynamic RangeControl the range of acoustic levels displayed in the image, which affects the contrast of the image.Touch Dyn Range +/- to adjust the amount of compression.7.1.8 Using Tissue Harmonic Imaging (THI)Reduce superficial artifact and provide better gray scale contrast by processing an integer multipleof the fundamental frequency, a harmonic wave.Touch THI to enable this function.7.1.9 Adjusting PersistenceAdjust the amount of frame averaging from real-time images or loops. Higher persistence producesless speckled and smoother image but reduces the temporal resolution.Touch Persist +/- to adjust the value.7.1.10 Adjusting Sharpness and SmoothingImprove the sharpness of the image by enhancing the edge contrast and smoothening the tissuespeckle.Touch QScan +/- to adjust the value.7.1.11 Adjusting Gray MapChange how the amplitude is converted to brightness.Touch Gray Map +/- to adjust the value.7.1.12 Adjusting Chroma MapAdjust the chroma (color tone and saturation) value with different brightness.Touch Chroma +/- to adjust the tone.7.1.13 Adjusting Steer AngleOptimize the viewing area by adjusting the steer angle. This function works only with linear arraytransducers.Touch Steering +/- to adjust the angle.
Using Image ControlsT3300 Diagnostic Ultrasound System |81 | B00601-010 4/10/177.1.14 Adjusting the Sector Width and PositionAdjust the ROI of the imaging area for image width and image position. A smaller sector widthincreases the frame rate.Touch Sector Width +/- to adjust the width. Touch Sector Pos +/- to adjust the position.7.1.15 Adjusting PowerAdjust the acoustic output power value to the expected target.Touch Power +/- to adjust the value.7.1.16 Using Trapezoidal ImagingIncrease the range of view of the ultrasound image when using a linear transducer.Touch Trap to enable trapezoidal imaging.7.1.17 Adjusting DensityAdjust the density of the scan lines. Higher density obtains better horizontal resolution with lowerframe rate, while lower density obtains higher frame rate.Touch Density repeatedly to select a desired line density.7.1.18 Using Compound ImagingReduce speckles and improve contrast resolution.• Frequency compounding: Combine multiple images acquired from different frequencies. TouchFQBeam to enable frequency compounding.• Spatial compounding: Combine multiple images acquired from different beam angles. TouchSQBeam repeatedly to enable and adjust spatial compounding.7.1.19 Using ENV (Enhanced Needle Visualization)When performing a biopsy with the supported transducer, the system offers on-screen needleassistance to further enhance imaging of the needle. Before using the ENV function, make sure thefollowing conditions are met:• B-mode is selected• An L154BH transducer is connected to the system• A patient profile is selectedTouch ENV to enable this function.A diverging dotted green line shows in the Imaging window. The point of the needle should be closeto vertical to the dotted line. The part of the needle image that goes beyond the limit will not bebrightened and can’t be seen. Tap ENV Angle +/-, if needed, to toggle between lines angled fromupper left to lower right and lines angled from upper right to lower left.NOTEThe system does not support the biopsy guide function. Do not use nor assemble any kind of needleguide kits/brackets on the transducer supported to avoid transducer damage or hurting the patient.
Using Image ControlsT3300 Diagnostic Ultrasound System |82 | B00601-010 4/10/177.2 Color/Power Mode Image Controls7.2.1 OverviewColor mode is used to detect the presence, direction, and relative velocity of blood flow by assigningcolor-coded information to these parameters. The color is depicted in a region of interest (ROI) thatis overlaid on the 2D image. Non-inverted flow towards the transducer is assigned shades of red,and flow away from the transducer displays in shades of blue.All forms of ultrasound-based imaging of red blood cells are derived from the received echo of thetransmitted signal. The primary characteristics of this echo signal are its frequency and its amplitude(or power). The frequency shift is determined by the movement of the red blood cells relative to thetransducer – flow towards the transducer produces a higher-frequency signal and flow away fromthe transducer produces a lower-frequency signal. Amplitude depends on the amount of movingblood within the volume sampled by the ultrasound beam. Large frequency shift generated by rapidflow is displayed in lighter colors, and smaller frequency shift in darker colors. In Power (Doppler Power Image) mode, low flow rate in small vessels are clearly observed. Colorsare carried out only to demonstrate the blood flow, but contain no velocity information, thus, offer nodirectional information. Both Color and Power modes can work with other scan modes to form duplex and triplex modes.Save FreezeHomeTGCTuningResolutionGeneralPenetrationEnd ExamGainScaleSteeringInvert Full ScreenB Color PWMPowerColorRenalBColor modeimageinformationFn KeyTouch to enableColor mode imagecontrols Save FreezeHomeTGCTuningResolutionGeneralPenetrationEnd ExamGainScaleSteeringDirectional Full ScreenBColor PWMPowerPowerRenalBPower modeimageinformationFn KeyTouch to enablePower mode imagecontrols
Using Image ControlsT3300 Diagnostic Ultrasound System |83 | B00601-010 4/10/177.2.2 Adjusting Pulse Repetition Frequency (PRF)Adjust the velocity range of the color flow display. The maximum velocity range depends on thetransducer in use and the location of the sample volume. Set the PRF high enough to preventaliasing, and low enough to provide adequate detection of slow blood flow. Upon adjusting the PRFvalue, the velocity scale shown on the Color/Power wedge and the Wall Filter setting are changedaccordingly.Touch Scale +/- to adjust the value.7.2.3 Inverting the Color DisplayInvert the color display in relation to the blood flow direction in Color mode. Normally, the color red isassigned to positive frequency shifts (flow toward the transducer), and blue is assigned to negativefrequency shifts (flow away from the transducer). Use this function to reverse this color assignmentand invert the colors on the color wedge.Touch Invert to invert the color scale.7.2.4 Using Directional PowerActivate Directional Power in Power mode for use in applications where sensitivity and directionalinformation are both required.Touch Directional to enable this function.7.2.5 Selecting a Color MapSelect which of five color maps is used to show Color Doppler data. Some maps use more colorsthan others, while some display in a smoother gradient than others.Touch Color Map +/- to select a color map.7.2.6 Adjusting Wall FilterReduce or eliminate unwanted low-frequency, high-intensity signals generated by movements ofblood vessel walls or by rapid movement of the transducer. Set the wall filter high enough to ensurethat the Color Doppler flash artifacts from tissue or wall motion are not displayed, but low enough todisplay slow flow. The adjustable range of the Wall Filter value is related to the current PRF value.Touch Wall Filter +/- to adjust the value.7.2.7 Applying the Smoothing FilterReduce color noise by applying a smoothing filter to the image.Touch Smoothing +/- to adjust the value.7.2.8 Adjusting the Color PriorityDefine the amount of color displayed over bright echoes, and help confine color within the vesselwalls.Touch Reject +/- to adjust the value.7.3 M-Mode Image Controls7.3.1 OverviewM-Mode imaging is used simultaneously with 2-dimensional (B-mode) imaging to determine patternsof motion for objects within the ultrasound beam. M-Mode displays scan data of the anatomy in the
Using Image ControlsT3300 Diagnostic Ultrasound System |84 | B00601-010 4/10/172D Imaging window , and the motion scan in the Time Series window . The M-Mode cursor line(M-line) appears vertically in the central area of the active 2D image, indicating the position of the M-Mode beam. Typically, this mode is used for viewing motion patterns of the heart.Drag the M-line to the target position to determine the presence of motion occurred along thesingular line.Touch M to enable M-Mode image controls.Touch to initiate the M-Mode trace which produces a scrolling display of movement (alongthe vertical Y axis), plotted against time (along the horizontal X axis).7.3.2 Using Steer MAllow steering the sample volume to any angle you choose by adding multiple M-lines, rather thansampling in a strict vertical position. This function is particularly useful in cardiology applications.1. Touch Steer M +/-.2. A crosshair cursor appears on the image. Drag the cursor to where you want to start samplingand release it.3. Drag the cursor to where you want to end sampling and release it.4. Touch Steer M +/- to display a second crosshair cursor. Repeat step 2-3 to place the secondline. Up to 3 M-lines can be added.7.3.3 Adjusting Sweep SpeedAdjust how fast the timeline is scanned across the Time Series window.Touch Speed repeatedly to select a desired velocity.7.3.4 Selecting M ProcessSelect the detection method processing the M-Mode trace display. The system provides retrievingaverage or peak scan data from the M-Mode trace.Touch M Process +/- to select a desired method.7.3.5 Inverting the M-Mode Trace DisplayInvert the M-Mode trace display in relation to brightness.Touch Video Invert to swap the colors on the M-Mode trace display.Save FreezeHomeTGCResolutionGeneralPenetrationGainSteer MFull ScreenBColor PWMPowerMCardiacBM- modeimageinformationVideo InvertSpeed1/2xEnd ExamUpdateM line12Fn Key12
Using Image ControlsT3300 Diagnostic Ultrasound System |85 | B00601-010 4/10/177.4 Spectral Doppler Mode Image Controls7.4.1 OverviewPulsed-Wave Doppler (PW) and Continuous Wave Doppler (CW) are collectively called SpectralDoppler mode. A Spectral Doppler scan produces a series of pulses used to study the motion ofblood flow selectively in the region of interest. PW/CW modes display scan data of the anatomy inthe 2D Imaging window for monitoring the exact location of the sample volume, and display the PW/CW data acquired in the Time Series window. The X axis of the graph represents time, and the Yaxis represents Doppler frequency shift. The shift in frequency between successive ultrasoundpulses, caused mainly by moving red blood cells, can be converted into velocity and flow if anappropriate angle between the insonating beam and blood flow is known.PW mode examines blood flow data selectively in a small region along a desired ultrasound cursor(the Spectral Doppler cursor), called the sample volume or range gate. A short line across thesample volume is called the Flow Direction cursor. This cursor line should be aligned to the bloodflow direction when measuring the flow velocity.Drag the Spectral Doppler cursor horizontally and the sample volume vertically to the target positionto determine the presence of blood motion.CW mode examines the flow data along the Spectral Doppler cursor rather than a small region.Save FreezeHomeTGCResolutionGeneralPenetrationGainSteeringAngleBColor PWMPowerPWCardiacBPW modeimageinformationInvertEnd ExamUpdateSpectral DopplerTuning-60,0,60SV SizecursorFlow directioncursorFn KeySave FreezeHomeTGCGainSteeringAngleBColor PWMPowerCWCardiacBCW modeimageinformationInvertEnd ExamUpdateSpectral DopplerTuning-60,0,60cursorCWCW cursorFn Key
Using Image ControlsT3300 Diagnostic Ultrasound System |86 | B00601-010 4/10/177.4.2 Adjusting BaselineAdjust the zero baseline up or down in the Time Series window.To adjust the baseline:• Touch Baseline +/-.• Touch and hold the baseline in Time Series window, then drag the baseline vertically to move it.7.4.3 Adjusting Sample Volume (SV) SizeAdjust the SV size which controls the size of the Doppler region being examined in PW mode.To adjust the SV size:• Touch SV Size +/-.• Touch and hold one finger on the Spectral Doppler cursor, then flick another finger up or down.7.4.4 Adjusting Correction AngleAdjust the correction angle to obtain accurate velocity. At angles greater than 70°, the error in thevelocity calculation is usually too large to use.• To toggle the angle between -60° and 60°, touch Angle -60,0,60 repeatedly.• Touch Angle +/- to adjust the angle to the desired number. • To manually adjust the angle, touch and hold one finger on the Spectral Doppler cursor, then flickanother finger to the left or right.7.4.5 Updating the 2D DisplaySelect whether or not to continue scanning the anatomy while acquiring PW Doppler scan data.Touch Duplex or Triplex to enable/disable this function.
T3300 Diagnostic Ultrasound System |87 | B00601-010 4/10/17CHAPTER8System CustomizationYou can customize your system to streamline your workflow and increaseefficiency. Use the setup tools to adjust sets of controls for defaults andother settings.This chapter covers the following topics:•"Customizing Your System" on page 88•"Servicing your system" on page 90
System CustomizationT3300 Diagnostic Ultrasound System |88 | B00601-010 4/10/178.1 Customizing Your SystemOn the system screen, touch > Settings. The setup tools are categorized into varioussections listed below. Touch each section to access the settings.8.1.1 General•Enable freeze gesture: Enable double-tapping the screen to freeze the real-time scan.•Language: Set the system language, and the system restarts automatically.•Export Settings/Import Settings: Insert an external storage, touch Export/Import and selectthe storage directory.8.1.2 Preset•Default preset/Preset list: Touch Edit, set the default preset and re-arrange the preset list onthe Preset screen, then touch Save.(See "Managing Presets" on page 61)•Export preset/Import preset: Export/import customized presets to/from your external storage.(See "Exporting and Importing Customized Presets" on page 61)8.1.3 Patient•Auto-create Patient Name and ID: Enable creating a set of patient name and ID every time youstart a new exam.•Show Study Information: If you want to protect user privacy, disable this function to concealuser and institution information during real-time scanning.•Patient Information Unit: Set the measurement unit for filling in patient information.8.1.4 Exam• Add logos and names for the institutions and operators.•Delete exams before: The system will automatically delete exams performed a certain period oftime ago. Select the time period from the drop-down menu, then touch Delete > OK to deleteexams matching the selected time period.8.1.5 Workflow•Screen after Enter Ultrasound: Select the screen to enter after starting/logging into the system.•Auto-freeze after Minutes: Set the number of minutes of waiting before the scan is frozenautomatically.•Status after Freeze: Assign the first action to perform after freezing the scan.8.1.5.1 BDMK (Body mark)•Auto-clear BDMK after Unfreeze: Enable clearing all the body marks added automatically afterreturning to the real-time scan.•Auto-add BDMK after Live Scan: Enable adding a body mark each time you start a new scan.8.1.5.2 Annotation•Auto-clear Annotation after Unfreeze: Enable clearing all the annotations added automaticallyafter returning to the real-time scan.
System CustomizationT3300 Diagnostic Ultrasound System |89 | B00601-010 4/10/178.1.5.3 Measurement•Auto-clear Measurement after Unfreeze: Enable clearing all the measurements addedautomatically after returning to the real-time scan.•Continue Next Measurement: Enable initiating a second measurement automatically after thefirst one is complete.8.1.5.4 Exam•Screen after End Exam: Select the screen to enter after touching End Exam.•Export DICOM after End Exam: Enable exporting the exam in DICOM file format to the DICOMserver automatically after touching End Exam.8.1.5.5 Print•Print while Save: Enable printing out the scanned image automatically after touching Save.8.1.5.6 Function KeyThe system provides a function (configurable) key for quick access to your frequently used action.•Function Key Actions: Touch Edit, assign a desired action to the function key, then touchSave.•Function Key Display Name: Edit the name for the function key.8.1.6 Imaging•Auto Focus by following CROI: Enable re-positioning focus to the center of the ROIautomatically when moving the ROI on the image in real-time Color/Power modes. •Auto CROI by following SV: Enable re-positioning ROI to keep the sample volume in the centerof the ROI when moving the sample volume on the image in real-time B+Color/Power+PW/CWmodes.•Auto Zoom-in Image for PW/CW Mode/Auto Zoom-in Ratio: Enable zooming-in imagesautomatically with the assigned ratio upon entering PW/CW modes. To change the zoom ratio,select a desired percentage.•Image Format: Select the saved image format.•Cine Loop Length in Seconds (Length may vary depending on frame rate): Set the cineloop length for each recording.•PW Output Unit/CW Output Unit: Set the velocity display unit in PW/CW modes.8.1.6.1 Display Layout•M Mode Display Format/PW Mode Display Format/CW Mode Display Format: Set theaspect ratio between the 2D imaging window and the time series window on the imaging screen.8.1.7 Annotation•Annotation Font Size/Arrow Size: Select a desired size.•Label List: Touch Edit, select an application and check/uncheck each label to re-arrange thelabel list, then touch Save.8.1.8 BDMK (Body Mark)•Default BDMK for Application: Touch Edit, select an application and touch a desired bodymark to set it as default, then touch Save.
System CustomizationT3300 Diagnostic Ultrasound System |90 | B00601-010 4/10/17•BDMK List: Touch Edit, select an application and enable/disable each body mark to re-arrangethe body mark list, then touch Save.8.1.9 Measurement•Configuration of Calculation List: Touch Edit. Select a preset from the Calculation Package todisplay available calculations below. To display/hide the calculation result after a set ofmeasurements are done, check/uncheck the calculation name. If you select OB, more than onecalculation method can be used in a calculation. Select the Author name to your desiredmethod/formula.•Result Unit: Set the measurement unit.•Caliper Size/Set Result Font Size: Select a desired size.•Show Measure Line: Enable showing the measuring lines after performing a measurement.•Result Position: Set the position of the measured results.•Show Result: Set whether to show all or the last measured results, or to hide them all.8.1.10 Report•Default Report Template: Select an application and set its default report template based on thepreset selected, then touch Save.•Built-in Prompt String/Built-in Finding String/Built-in Comment String: Touch Edit, edit oradd built-in strings used in the report, then touch Save.•Report Display: Touch Edit, and select the display type of the Calculation Package in the report.8.1.11 DICOMConfigure DICOM settings. For more information, see "DICOM Configuration" on page 55. 8.1.12 Networking• Display the network connection status of the system in the Information window.–Current Status: The IP address currently connected.–Detailed Status: All IP addresses and MAC addresses.• Configure the system network.–Wifi Configurations: See "Connecting the System to the Wireless Network" on page 54.–Ethernet Configurations: See "Connecting the System to the Network by Ethernet" on page 54“.8.1.13 Print•Image Printer/Report Printer: Assign the printer for use when printing images/reports.•Network Printing: Configure printer settings.•Image Color Invert: Print out the image with colors inverted.8.2 Servicing your systemIf you encounter any problem using the system, need to update software, backup and restore dataor use the on board diagnostic tools, select the service tools. Some functionality may require accesskeys and consultation available from technical support.
System CustomizationT3300 Diagnostic Ultrasound System |91 | B00601-010 4/10/17On the system screen, touch > Settings > Service. The service tools are categorized intothe following sections.• Managing your system: Touch System Management. System information, software update,backing up and restoring data can be found here.• Testing your system: Touch Test & Utilities. Use the diagnostic tools here to test the systemfunctionality.• Exporting system logs: Touch System Logs. Test results of the system functionality can befound here. • About your system: Touch About. The system’s main version and the tablet’s serial number(default password for the first-time-logging-in) can be found here.8.2.1 Reinstalling SoftwareThis requires further assistance. Please contact technical support (See "Contact Information" onpage 2). An access key is required. Once the access key is provided, the installation will require aUSB flash drive with the software ZIP file. Please allow five to ten minutes for installation. Thesystem will restart after completed. All settings and patient data are preserved but it is good practiceto ensure recent backups have been performed.Touch System Management > (Software Maintenance) > (Reinstall Software) > Update.NOTEEnsure regular backups of patient data and settings. It may be important in the event of a failure tohave current configuration data.8.2.2 Checking the Software VersionThis may be required when contacting Technical Support.Touch System Management > (Software Maintenance) > (Software Version).8.2.3 Checking the Tablet’s Serial NumberList the serial number of the tablet. This is assigned and cannot be changed. To check your tablet’s serial number:• Touch System Management >(System Information) > (Tablet Serial Number).• Refer to the spec label on the back of your system.8.2.4 Checking the License StatusList current licenses and options that are installed. It may need to be reinstalled with assistance fromtechnical support when a replacement tablet is received and no licenses are installed.Touch System Management > (System Information) > (License Status).8.2.5 Resetting System SettingsPerforming this action will reset all system settings of the current user and is irreversible. Considerbacking up your settings to an external storage device first.Touch System Management > (System Configuration) > (Reset System Settings) > Reset.
System CustomizationT3300 Diagnostic Ultrasound System |92 | B00601-010 4/10/178.2.6 Backing Up System Settings and Patient DataCAUTIONCAUTIONIn the event a system issue occurs and a replacement system is required all configurationsettings and patient data may be lost. It is your responsibility to back up data regularly!NOTEBefore backing up system settings and patient data, ensure that the system is connected to anexternal storage device.1. Touch System Management > (System Configuration).2. Touch Backup in the following fields:–Backup System Settings & Patient Data: All the system settings, presets and exams are saved to the external storage device. The following file naming convention is applied to the backup file: Backup_YYYYMMDD_HHMMSS–Backup Patient Data: All the exams are saved to the external storage device. The following file naming convention is applied to the backup file: Backup_PATIENT_YYYYMMDDHHMMSS8.2.7 Restoring System Settings and Patient DataNOTEBefore restoring system settings and patient data, ensure that the system is connected to anexternal storage device containing stored system settings and patient data.Touch System Management > (System Configuration).Touch Restore in the following fields, and select a backup file:•Restore System Settings & Patient Data: All the system settings, presets and exams arerestored to the system from the external storage device.•Restore Patient Data: All the exams are restored to the system from the external storagedevice.8.2.8 Resetting Your SystemNOTEThis action is irreversible. Consider backing up your up system settings and patient data to anexternal storage device first.Performing this action will restore your system to its factory state and erase all your user settingsand patient data from the system storage, except the tablet serial number.Touch System Management > (System Configuration) > (Factory Reset) > Erase.
T3300 Diagnostic Ultrasound System |93 | B00601-010 4/10/17CHAPTER9Transducer and System MaintenanceThe transducers and the system require proper care, cleaning, andhandling. This chapter contains information and instructions to help youeffectively clean, disinfect, and sterilize the transducers and the system.This chapter covers the following topics:•"Transducer Maintenance" on page 94•"Transducer Storage" on page 94•"Transducer Storage" on page 94•"Transducer Care" on page 95•"Inspecting the Transducer" on page 96•"Transducer Care Method" on page 97•"Transducer and Cable Cleaning" on page 97•"Ultrasound Transmission Gels" on page 98•"Compatible Disinfectants and Cleaning Solutions" on page 99•"System Maintenance" on page 99
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |94 | B00601-010 4/10/17The transducer is the most important factor in image quality. Optimal imaging cannot be obtainedwithout the correct transducer. The system is optimized for use based on your transducer selection.9.1 Transducer MaintenanceTransducers are highly-sensitive instruments and require proper care, cleaning, and handling.Reasonable care includes inspection, cleaning, and disinfection or sterilization, as necessary.Inspect the transducer, cable, and lens before each use. Check for cracks or other damage thatjeopardizes the integrity of the transducer. Report any transducer damage to your BenQ MedicalTechnology representative, and discontinue use of the transducer.For all information on transducer cleaning and disinfection, see "Transducer Care" on page 95.For all information about the use of acoustic coupling gels, see "Ultrasound Transmission Gels" onpage 98.If you encounter poor image quality or transducer problems, see "Troubleshooting" on page 103“.NOTESome ultrasound coupling gels, as well as some solutions for pre-cleaning, disinfecting, andsterilizing can damage a transducer. Before using a gel or solution on a transducer, see "UltrasoundTransmission Gels" on page 98 or "Transducer Care" on page 95“. You can also contact your localBenQ Medical Technology representative. For contact information, see "Contact Information" onpage 2.9.2 Transducer StorageUse the appropriate guidelines for storing transducers for transport, and daily and long-term storage.For information on temperature and humidity requirements, see "Appendix A: Specifications" onpage 108.9.2.1 Storage for TransportIf a carrying case is provided with your transducer, always use the carrying case to transport thetransducer from one site to another. Follow these guidelines to properly store transducers fortransport:• Make sure that the transducer is clean and disinfected before placing it in the case to avoidcontaminating the foam that lines the carrying case.• Place the transducer in the case carefully to prevent kinking of the cable.• Before closing the lid, make sure no part of the transducer is protruding from the case.• Wrap the case in plastic material containing air-filled pockets (such as Bubble Wrap material),and pack the wrapped case in a cardboard carton.9.2.2 Daily and Long-Term StorageFollow these guidelines to protect your transducer:• Always store transducers in the transducer holders or on a securely mounted wall rack when youare not using them.• Ensure the transducer holders are clean before storing transducers.• Avoid storing transducers in areas of temperature extremes or in direct sunlight.• Store transducers separately from other instruments to avoid inadvertent transducer damage.• Before storing transducers, make sure they are thoroughly dry.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |95 | B00601-010 4/10/179.3 Transducer CareReasonable care includes inspection, cleaning, and disinfection or sterilization, as necessary.Transducers must be cleaned after each use. Inspect all parts of the transducer carefully beforeeach use. Check for cracks or other damage that jeopardizes the integrity of the transducer.9.3.1 Transducer Care and Operator SafetyObserve the following warnings and cautions during all cleaning, disinfection, and sterilizationprocedures and when using disinfectants. WARNINGDisinfectants are recommended because of their chemical compatibility with productmaterials, not their biological effectiveness. For the biological effectiveness of a disinfectant,see the guidelines and recommendations of the disinfectant manufacturer, the U.S. Food andDrug Administration, and the U.S. Centers for Disease Control.WARNINGThe level of disinfection required for a device is dictated by the type of tissue it will contactduring use. Ensure the disinfectant type is appropriate for the type of transducer and thetransducer application. For information on the levels of disinfection requirements, see"Transducer Care" on page 95.WARNINGS• Do not drop the transducer on a hard surface, as this will damage the transducerelements and compromise the electrical safety of the transducer.• Do not allow sharp objects, such as scissors, scalpels, or cauterizing knives, to touchtransducers or cables.• Do not use damaged or flawed transducers.WARNINGS• Use only the approved ultrasound coupling gels.• Use only couplants specifically designed for ultrasound examinations. Do not usemineral-oil or vegetable-based couplants, which can damage transducers.WARNINGIf a pre-mixed solution is used, be sure to observe the solution expiration date.WARNINGS• Transducers must be cleaned after each use. Cleaning the transducer is an essential stepbefore effective disinfection or sterilization. Be sure to follow the manufacturer’sinstructions when using disinfectants.• When sterilizing a transducer, ensure that the sterilant solution’s strength and duration ofcontact are appropriate for sterilization. Be sure to follow the manufacturer’sinstructions.WARNINGAttempting to clean or disinfect a transducer, cable, or connector by using a method otherthan the procedures provided here can damage the device and voids the warranty.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |96 | B00601-010 4/10/17WARNINGDo not use a surgeon’s brush when cleaning transducers. Even the use of soft brushes candamage transducers.WARNINGDo not use paper products or products that are abrasive when cleaning the transducer. Theydamage the soft lens of the acoustic window of the transducer.WARNINGDuring cleaning, disinfection, and sterilization, orient the connector and cable that mustremain dry higher than the wet parts, until all parts are dry. This helps keep liquid fromentering unsealed areas of the transducer.WARNINGWhen cleaning and disinfecting transducers, do not allow any fluid to enter electricalconnections or metal portions of the connector. Damage due to fluids in these areas is notcovered by the warranty or your service contract.WARNINGWhen using an enzymatic cleaner, be sure to use the proper concentration and rinsethoroughly.WARNINGBefore storing transducers, ensure that they are thoroughly dry. If it is necessary to dry thetransducer lens or acoustic window after cleaning, use a soft cloth and a blotting motion,instead of a wiping motion.WARNINGUse only liquid solutions to sterilize transducers. Using autoclave, gas (EtO), or othermethods not approved by BenQ Medical Technology will damage your transducer and voidyour warranty.WARNINGDo not soak the transducer for extended periods of time. Limit the time and depth thattransducers are soaked in disinfectant solution to the minimum time recommended by thedisinfectant manufacturer.9.4 Inspecting the TransducerInspect the transducer’s acoustic lens, the cable, and the transducer connector before each use.Check the transducer carefully and see if there are cracks, cuts, or any other damages which mayadmit fluids. Do not use the transducer if it is damaged.If the transducer is dropped, examine it immediately for signs of damage. Perform a sample scan tomake sure it operates correctly. Contact BenQ Medical Technology for service or replacement if anyabnormalities are found.NOTETo avoid any possibilities of hurting the patient, check if the transducer has a smooth edge and aneven surface before each use.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |97 | B00601-010 4/10/179.5 Transducer Care MethodThe transducers supported by this system are classified as non-critical types which require low-leveldisinfection. Low-level disinfection of transducers uses the spray or wipe method, with a low-level orintermediate-level disinfectant.1. Clean the transducer and cable according to the procedures in "Transducer and CableCleaning" on page 97. Observe all warnings and cautions.2. After cleaning, choose the low- or intermediate-level disinfection solutions compatible with yourtransducer, cable, and connector. For a list of disinfectants compatible with your transducer, see"Ultrasound Transmission Gels" on page 98. Follow the label instructions for preparation,temperature, solution strength and duration of contact. Ensure that the solution strength andduration of contact are appropriate for the intended clinical use of the device. 3. Wipe or spray the transducer, cable, strain relief, and connector with the disinfectant, followingthe disinfectant label instructions for temperature, wipe durations, and duration of disinfectantcontact. Ensure that the disinfectant solution does not enter the device or the connector. Do notallow any type of fluid to enter the connector. Ensure that fluid does not enter through the strainrelief, through the connector, or through the electrical contacts. Fluid in the connector may voidthe device warranty.4. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.9.6 Transducer and Cable Cleaning These general cleaning instructions are indicated for all supported transducers, cables, andconnectors. It is important that you clean the transducer, cable, and connector according to thefollowing procedures. Before cleaning a transducer, read "Safety Information" on page 6. Aftercleaning, you must disinfect or sterilize transducers by following the appropriate procedures.NOTEAlways use protective eyewear and gloves when cleaning and disinfecting any equipment.9.6.1 Cleaning Instructions1. After every patient exam, use a moist cloth to remove the ultrasound transmission gel from thetransducer.2. Disconnect the transducer from the system, and remove any accessories attached to orcovering the transducer.3. To remove all organic matter and other residue, use a pre-cleaner or detergent to assist inremoving protein residuals. Enzymatic cleaners must be diluted prior to use per themanufacturer’s instructions for dilution. Enzymatic cleaners are generically approved for use.4. When cleaning the lens, use a blotting motion rather than a wiping motion.5. To remove remaining particulate and cleaning residue, use cleaning wipes according to themanufacturer’s instructions.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |98 | B00601-010 4/10/176. Transducers can be submerged up to, but not including, the strain relief of the transducer array.Do not immerse or soak any other part of a transducer in any cleaning material. The followingfigure defines how much of the transducer can be submerged. 7. Wipe with a dry cloth if necessary. To dry the lens, use a soft cloth and a blotting motion insteadof a wiping motion.8. Examine the device and cable for damage such as cracks, splitting, sharp edges, or projections.If damage is evident, discontinue use of the device and contact your BenQ Medical Technologyrepresentative.NOTEThe cable and connector are not waterproof. Do not immerse the cable or allow liquid to contact theconnector.9.7 Ultrasound Transmission GelsFor proper transmission of the acoustic beam, use the ultrasound transmission gel supplied by orrecommended by BenQ Medical Technology, or another glycol-, glycerol-, or water-based acousticcoupling medium.WARNINGFor intraoperative applications, use only the Sterile Aquasonic or Sterile Ultraphonic gelprovided with the transducer cover.CAUTIONCAUTIONDo not use hand sanitizing gels.CAUTIONCAUTIONDo not use lotion-based products or gels that contain mineral oil. Such products damage thetransducer and void the warranty.CAUTIONCAUTIONDo not apply the transducer gel until you are ready to perform the procedure. Transducersshould not be left soaking in gel.CAUTIONCAUTIONGels listed here are recommended because of their chemical compatibility with productmaterials.Do Not Submerge Transducers Above Line (Example transducer C62B)
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |99 | B00601-010 4/10/17Some recommended gels include:• Aquasonic 100• Aquasonic Clear• Carbogel-ULT•Scan9.8 Compatible Disinfectants and Cleaning SolutionsThe following list is the disinfectants and cleaning solutions compatible with the transducersavailable for the system.• Mild soap solution• Purified water• 70% isopropyl alcohol (IPA)• 75% Ethanol alcohol • Bleach (500~1000ppm solution in water)• MinutenSpary• M415•OROLIN® BurbathWARNINGS• The only parts of the transducer that may be cleaned with isopropyl alcohol are thetransducer housing and lens or acoustic window. Ensure that the solution is only 70%alcohol or less. Do not wipe any other part of a transducer with isopropyl alcohol(including cables, connectors, or strain reliefs), as it can damage those parts of thetransducer. This damage is not covered by the warranty.• Do not use any ammonia based disinfectants. If used it can cause damage to the plasticsor to the system.9.9 System MaintenanceMaintenance should be performed regularly and as needed.9.9.1 Inspecting the SystemInspect the system’s touch glass, outer cover, port cover, probe cover and the stand before eachuse. Check the system carefully and see if there are cracks, cuts, or any other damages which mayadmit fluids. If the system is dropped, examine it immediately for signs of damage. Perform a sample scan tomake sure it operates correctly. Contact BenQ Medical Technology for service or replacement if anyabnormalities are found.9.9.2 Cleaning the SystemThe system and peripherals are medical electrical equipment and require thorough cleaning. Ifexposed to constant and excessive environmental dust and humidity, both performance andreliability of these devices will suffer. Clean the power adapter, ventilation slots, all connection ports/sockets and the touch screen regularly or whenever you observe dust or other particles.For information on transducer cleaning and disinfection, see "Transducer Care" on page 95.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |100 | B00601-010 4/10/17WARNINGS• Before cleaning the system, perform the following operations to avoid the risk of electricshock:1. Turn off the system power.2. Disconnect the power adapter from the system and the power outlet.• Running the system for a long period of time may generate excessive heat. Do not cleanthe system until it completely cools down. 9.9.2.1 Cleaning the System/Surfaces/probe holderWARNINGThe system connection ports, external monitor port, power adapter port and other openingsin the enclosure are most likely to be affected by liquid spills and other materials such asexcessive amounts of gel. These materials may seep into electrical components under theenclosure and cause intermittent failures. During preventive maintenance, look for potentialproblems, such as gaps or cracks.1. Gently wipe the system/surfaces/probe holder with a lint-free, non-abrasive and dry cloth.2. Moisten the cloth with soapy water and gently wipe it across the surfaces in one direction.WARNINGMoving the cloth back and forth on the touch screen will damage the screen.3. Remove any solid matter around the ventilation slots, connection ports, and power adapter portwith a cotton swab or toothpick to ensure that solids are not pushed into the system.4. If blood or other infectious material comes in contact with the system, or any cable, apply a smallamount of specific cleaning solutions or disinfectants (See page 100) to the cloth, and gentlywipe it across the surfaces in one direction. Repeat the application and cleaning process severaltimes until the spots are dissolved.5. Remove any residue with a cloth moistened with sterile water.6. Wipe off any excess moisture then leave the surfaces completely dry before powering thesystem back on.The compatibility of disinfection and cleaning solutions varies depending on the item on which theyare used. The following products are compatible with the external plastic and painted surfaces ofsystem.• Cleaning solutions for all surfaces: – Mild soap solution• Cleaning solutions for the touch screen: – Mild soap solution– Cleaners designed for touch screens– Purified water
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |101 | B00601-010 4/10/17• Disinfectants for system surfaces, including the touch screen:– 70% isopropyl alcohol (IPA)– 75% ethanol alcohol– RBS M415 (Quaternary ammonium compounds based)– ALPRO MinutenWipes (Ethanol/IPA/chlorhexidine-digluconate/dialkyldimethylammoniumchioride/alkylamine derivatives based)– ALPRO MinutenSpary (Ethanol/IPA/chlorhexidine-digluconate/dialkyldimethylammoniumchioride/alkylamine derivatives based)WARNINGIf blood or other infectious material comes in contact with a transducer or transducer cable,do not wipe with isopropyl alcohol until you have read the "Transducer Care" on page 95 forspecific cleaning guidelines. Isopropyl alcohol should not be used on some parts of thetransducer and should never be used on any parts of the transducer cable. Additionalcleaning agents are also available for transducers.CAUTIONCAUTION• Do not use abrasive cleaners, or acetone, MEK, or other strong solvents on the system,peripherals, or transducers.• Do not use Sani-Cloth AF4 or Super Sani-Cloth to disinfect the system.• On display screens, do not use glass cleaners or products containing bleach.Immediately wipe away disinfectants or cleaners to prevent residue buildup.• On display screens, use microfiber cloth; do not use paper towels.• System surfaces and transducers are resistant to ultrasound gel, alcohol, anddisinfectants, but if you use those substances, you must wipe them off to preventpermanent damage.• Always use protective eyewear and gloves when cleaning and disinfecting anyequipment.• Attempting to disinfect a cable or connector by using a method other than the oneincluded here can damage the device and voids the warranty.• Orient the parts that must remain dry higher than the wet parts until all parts are dry.• Do not use strong solvents, common cleaning products, or abrasive cleansers, which will• damage the system surfaces.• When cleaning the system surface with cleaning solutions or disinfectants, take care notto wipe repeatedly or rub heavily on the BenQ Medical Technology logo and model name.The printing inks may start to appear faded or stained.• Do not touch the display with sharp objects or use paper towels to clean it, which maydamage it.• When cleaning the system, take care not to get any solution inside the protectiveenclosure. Also take care not to scratch the face of the screen while cleaning it.• Do not use cleaners containing bleach on the touch screen. It may damage the surface.9.9.2.2 Cleaning the Power AdapterCAUTIONCAUTION• Do not immerse the power adapter.
Transducer and System MaintenanceT3300 Diagnostic Ultrasound System |102 | B00601-010 4/10/17• Keep moisture and liquid away from the power adapter. Do not spill or spray liquid on theadapter.1. Wipe the power adapter with a dry cloth.2. If spot cleaning is necessary, wipe with a cloth dampened with soapy water. If disinfection isnecessary, wipe with an alcohol-moistened cloth.3. Remove any solid matter with a cotton swab or toothpick to ensure that solids are not pushedinto the adapter.4. Wipe off any excess moisture then leave the power adapter completely dry before plugging itinto the system or power outlet.
T3300 Diagnostic Ultrasound System |103 | B00601-010 4/10/17CHAPTER10 TroubleshootingFrequently asked questions and common problems that may occur whileusing the system are explained in this section. Observe the followingtable containing a list of symptoms and the actions to take to solve theproblems.If a problem persists after performing the following actions, contacttechnical support (See "Contact Information" on page 2).
TroubleshootingT3300 Diagnostic Ultrasound System |104 | B00601-010 4/10/17Table 1 TroubleshootingSymptom Possible cause and corrective actionThe system does not power on•Battery fully discharged. Connect the AC power adapter.• Power adapter does not function correctly.> Check if the power adapter has blue light illuminated.> Check if the AC plug is connected firmly and correctly to the power adapter and matches the plug type of your country.> Check if the power adapter is connected firmly and correctly to the system. (See "Charging the System" on page 33)The system can’t charge or experience short runtime between chargesPower supply is damaged/battery reaches end of life.> Allow the battery to charge overnight and check again the battery status.> Contact technical support.Unsure of a function displayed in localized languages> Switch the system language back to English from > Settings >General > Language, and check again the function you want to use.> Contact technical support.The system can’t read/write data from the microSD card•One or two USB storage devices are connected to the system at the same time.*> Remove all the connected USB storage devices from the system.• The microSD card is damaged.> Insert the microSD card into a computer for inspection.• The microSD card slot is damaged.> Insert another microSD card into the system for inspection.The system can’t read/write data from the USB storage device•Two USB storage devices are connected to the system at the same time.*> Ensure the USB storage device you wish to read/write data from is connected to the system through the USB 3.0 port.• The USB storage device is damaged.> Insert the USB storage device into a computer for inspection.• The USB ports are damaged.> Insert another USB storage device into the system for inspection.No image or abnormal display on the system screenThe system screen is not functioning.> Output the system display to an external monitor (Seepage 39) and check if images display normally on the external screen.> Contact technical supportImage Artifacts occur on the imaging screen• Electrical interference occurs.> Move system away from any electromagnetic sources.> Remove the power adapter and other external devices (if any) from the system while keeping the transducer plugged for inspection.• The transducer connected is damaged.> Replace current transducer with another for inspection.
TroubleshootingT3300 Diagnostic Ultrasound System |105 | B00601-010 4/10/17Software installation failed Check if the USB flash drives or the system’s USB ports are damaged.The Power button does not functionThe system power reaches a critically low state and is not connected to power.> Connect the system to power.The system is overheating• The system’s fans are not functioning.> Contact technical support.• Ventilation slots are blocked.> Place the system in a well-ventilated area.> Remove any dust particles or stains found on or nearby the ventilation slots.The system encounters unexpected shutdowns several timesA system disk error occurred.> Reinstall the software (See "Reinstalling Software" on page 91). This requires assistance from technical support.Touch screen is unresponsive or misconfigured• Touch screen is damaged.> Inspect the panel surface carefully for cracks, cuts or any other damages.• Software malfunctions.> Connect a pointing device to the system through the USB port, and check if the pointer is displayed correctly on the screen.No audio or noise comes from the system speakers• The system is muted.> Open the Quick Setup menu and adjust the volume.• The speakers are damaged.> Contact technical support.HDMI does not functionThe HDMI cable/port is damaged.> Use another HDMI cable for connection.> Connect the system to a computer through HDMI connection for inspection.Bluetooth connection failed• The Bluetooth settings are not correct.> Turn off the Bluetooth function, then turn it back on.• The Bluetooth module is not functioning.> Connect another Bluetooth device to the system for inspection.DICOM connection failedThe DICOM server is not responding or the DICOM settings are not correct.> Go to > Settings > DICOM > Storage SCP and touch Edit > Test for verification.Table 1 TroubleshootingSymptom Possible cause and corrective action
TroubleshootingT3300 Diagnostic Ultrasound System |106 | B00601-010 4/10/17*The system supports access to only one external storage device at a time. If you connect more thanone external storage device, they function in the following priority order: USB 3.0 > USB 2.0 >microSD card.Ethernet does not function• The Ethernet settings are not correct.> Contact your network administrator.• The Ethernet cable/socket is damaged.> Use another Ethernet cable for connection.> Connect the system to a computer through Ethernet connection for inspection.Wireless connection failed• The wireless device is turned off or not functioning.> Check the power of the wireless device.> Restart the wireless device.> Connect another wireless product to this device for inspection.• The wireless network settings are not correct.> Open the Quick Setup menu and check if the wireless network function is enabled.> Contact your network administrator.Table 1 TroubleshootingSymptom Possible cause and corrective action
T3300 Diagnostic Ultrasound System |107 | B00601-010 4/10/17CHAPTER11 AppendicesThis chapter covers the following topics:•"Appendix A: Specifications" on page 108•"Appendix B: Connectivity and Security" on page 112•"Appendix C: System Acoustic Output Default Tables" on page 115•"Appendix D: Acoustic Output Reporting Tables for Track 3" onpage 119•"Appendix E: FCC Statement" on page 155
AppendicesT3300 Diagnostic Ultrasound System |108 | B00601-010 4/10/1711.1 Appendix A: Specifications11.1.1 SystemTable 1 System SpecificationsItem SpecificationForm factor TabletWeight 5.73 lb (2.6 kg): with standDimensionsLength 13.70" (348.2 mm)Width 9.39" (238.5 mm)Height (Thickness) 1.52" (38.5 mm): without stand2.22" (56.4 mm): with standMaterials Plastic, metal, rubberColor Black and WhiteSpeaker 2 built-in speakersConsole Touch screenPrimary monitor 13.3" 1920x1080Number of transducer connectors 1 transducer connectorStand 1 standMounting VESA standard (75mmx 75mm/100mm x 100mm)Water resistant level IP21CPU Qualcomm APQ8074ABUser interface languages English, T/S Chinese, French, German, Spanish, RussianMemory 16GB eMMCStorage mSATA 128GB SSD; support up to 512GBConnectivity• HDMI x 1• Audio output x 1• Ethernet RJ45 x1• USB 2.0 x1• USB 3.0 x1• MicroSD slot x1• Transducer x1Power Battery power/chargeable with up to 19V AC adapterBattery Non-removable battery with 1.5 hour run-timeAccessoryAdapter:• Input: AC 100 ~ 240V, 50 ~ 60Hz, Max 1.6A• Output: +19Vdc, 3.43A Transducer:C62B, L154BH, P42B6Storage/transportTemperature: -20 ~ 60°CHumidity: 20% ~ 95% RHAir pressure: 700 ~ 1060hPa
AppendicesT3300 Diagnostic Ultrasound System |109 | B00601-010 4/10/17CAUTIONCAUTIONTo avoid electrical shock, keep the system in dry location.11.1.2 TransducerEnvironmental operating conditionsTemperature: 10 ~ 40°CHumidity: 20% ~ 85% RH, no condensationAir pressure: 700 ~ 1060 hPaNo condensationProduct life 5 yearsTable 2 Transducer specificationsTransducer Elements Descriptions ApplicationsP42B6 64 Phased-linear array transducer with a maximum depth of 200 mm and a user-controllable field-of-view • CardiacC62B 128 Curved linear array transducer with a maximum depth of 200 mm and a user-controllable field-of-view• Abdominal• OB• GYN• Renal• UrologyL154BH 128 Linear wideband array transducer with a maximum depth of 150 mm and a user-controllable field-of-view• Carotid• Arterial• Venous• Thyroid• Breast• MSK• NerveTable 1 System SpecificationsItem Specification
AppendicesT3300 Diagnostic Ultrasound System |110 | B00601-010 4/10/1711.1.3 AdapterCAUTIONCAUTIONTo avoid electrical shock, keep the adapter in dry location. NOTESpecifications are subject to change without prior notice.11.1.4 BatteryModel: APP00201Battery type (non-removable): 3S2P Panasonic-3070mAh, compliant with IEC62133 standardTable 3 Adapter SpecificationsItem SpecificationsBrand Adapter Technology Co., Ltd.Model ATM065-P190Input Universal AC 100 ~ 240 Vac/50 ~ 60Hz Input, without any slide switchOutput +19Vdc, 3.43ACase Dimension 119 (L) * 60 (W) * 36 (H) mmEfficiency Eff (av) 87%Safety I.T.E. - PSE / BSMI / CCCMedical - UL / cUL / T-markEMI CE / FCC Class B, Conduction and Radiation Met.Protection OVP (Over Voltage Protection), SCP (Short CircuitProtection), OCP (Over Current Protection)Features • High frequency design, less power consumption• Suitable for usage at Medical Equipment• Meet DoE / ErP (Stage 2) / NRCanTable 4 Battery SpecificationsItem Rateperformance RemarkBattery Cell 3070 mAh PanasonicTypical capacity Above 6140 mAh Rate discharge capacity after rate chargeNominal capacity Above 5833 mAh Rate discharge capacity after rate chargeNominal voltage 10.8 V Mean operation voltage during rate discharge after rate chargeMaximum charge voltage 12.6 V CV mode charging voltageVoltage at end discharge 9.0 V Stop discharge when any cell reaches tc 2.7 ± 0.02 V
AppendicesT3300 Diagnostic Ultrasound System |111 | B00601-010 4/10/17Suggested charge current (Standard) 1.2 ASuggested charge current (maximum) 3.0 ASuggested continuous discharge current 3.0 A ʀ33WSuggested maximum discharge current 7.0 A ʀ78WEND of charge condition 150 mA 1 minOperating temperature0 ~ 45°C10 ~ 45°C-0 ~ 60°CStandard chargingIn max. chargingStandard dischargingPower consumption Normal modeSleep modeShutdown modeʀ620ȝAʀ120ȝAʀ5.42ȝATable 4 Battery SpecificationsItem Rateperformance Remark
AppendicesT3300 Diagnostic Ultrasound System |112 | B00601-010 4/10/1711.2 Appendix B: Connectivity and Security11.2.1 IntroductionTo exchange ultrasound images and patient data, the system conforms with the Digital Imaging andCommunications in Medicine (DICOM) standard and can therefore be connected to PictureArchiving and Communication System (PACS) and Modality Worklist (MWL). The former allows thesystem to store the acquired examination data (static images or image loops) in PACS, while thelatter allows the system to query examination orders from the MWL server and start theexaminations. In order to achieve the purposes above, the system offers two ways of connecting tothe IT network, hard-wired LAN and wireless LAN connections, for DICOM communication.NOTETo ensure the data security, use an IT network isolated from the external environment by a firewall.11.2.2 Specifications11.2.2.1 Hardware802.11 a/b/g/n, Gigabit Ethernet11.2.2.2 SoftwareThe system is connected to PACS and MWL by DICOM standard.NOTERead the system’s DICOM Conformance Statement for detailed instructions.11.2.2.3 SecurityThe system has no listening ports open to the Wifi interface. So a network entity cannot initiate aconnection to the system from the Wifi. However, the system can initiate a connection to servers onthe Wifi, Gigabit Ethernet and beyond. Computer access to the system through the USB port isblocked.The system allows connection via Bluetooth with limited devices (HID) only.Use the following TCP/IP ports for outgoing communication to the Wifi and Gigabit Ethernet.– Port for DICOM communication (typically port 104, 2762 or 11112; to specify the port, on the system’s imaging screen, touch > Settings > DICOM.– Port 80 for HTTP web servers (not supported by the system)– Anti-virus software is not installed on the system
AppendicesT3300 Diagnostic Ultrasound System |113 | B00601-010 4/10/1711.2.2.4 Information Flow11.2.2.5 IT Network Failure Recovery MeasuresIT network connection stability depends on many factors. Unreliable connection may later lead tofailure and cause the following hazardous situations.Any connection of the equipment, this system (T3300) or/and other systems, to the IT network risksthe unidentified data leakage of the patients, operators or third parties. It is recommended to set upthe device in a secure network and behind the firewall. The potential risks and suitablecountermeasures are evaluated and identified in the following table before connecting theequipment to an uncontrolled IT network. Therefore, you must evaluate and identify all potentialWorklist serverT3300PACS serverWorklist queryWorklist responseEcho responseDICOM storage/Echo request
AppendicesT3300 Diagnostic Ultrasound System |114 | B00601-010 4/10/17risks as well as prepare suitable countermeasures before connecting the equipment to anuncontrolled IT network. For guidance addressing these risks, refer to IEC 80001-1:2010.Even when the connection to an IT network is trusted, any change of the network settings requiresimmediate checkup and possible measures taken. Should any of the changes below occur, performadditional evaluation to the IT network.• Changes in the network configuration (IP address, router, proxy, and so on)• Connection of additional items• Disconnection of items• Equipment update• Equipment upgradeTable 5 IT network failure recovery measuresIT Network failure Impact on the equipment Hazard System countermeasuresIT network becomes unstableUnable to transmit exam data to a PACSDelay of diagnosisExam data is stored in the system’s internal storage. After the IT network has resumed Delay of transmission to a stability, you can re-initiate the data transfer.Delay of transmission to a PACSIncorrect data transmitted to a PACS Mis-diagnosisThe system uses the TCP/IP and DICOM protocols to ensure the integrity of the data.Unable to retrieve order data from an MWL server Delay of exam You can initiate/create a new exam from the system.Delay of retrieving order data from an MWL serverIncorrect data from a MWL server Incorrect examThe system uses the TCP/IP and DICOM protocols to ensure the integrity of the data.Firewall has broken downAttack via network Manipulation of the exam dataThe system closes unnecessary network ports.Infection by computervirus Exam data leakage The system forbids installation of any software by any user.
AppendicesT3300 Diagnostic Ultrasound System |115 | B00601-010 4/10/1711.3 Appendix C: System Acoustic Output Default Tables11.3.1 C62B TransducerTable 6 System Acoustic Output Default Table (C62B transducer)Preset Mode TI Label Default TI Default MIAbdomenB TIS=TIB 0.024 0.631Color TIS=TIB 0.265 0.826Power TIS=TIB 0.267 0.826M TIB 0.163 0.645PW TIB 1.154 0.688Color-Triplex TIB 1.623 0.753Power-Triplex TIB 1.586 0.761OBB TIS=TIB 0.021 0.628Color TIS=TIB 0.380 0.752Power TIS=TIB 0.379 0.746M TIB 0.173 0.646PW TIB 1.137 0.689Color-Triplex TIB 1.839 0.718Power-Triplex TIB 1.688 0.757RenalB TIS=TIB 0.026 0.710Color TIS=TIB 0.352 0.849Power TIS=TIB 0.362 0.845M TIB 0.229 0.735PW TIB 0.988 0.715Color-Triplex TIB 1.296 0.721Power-Triplex TIB 1.225 0.804UrologyB TIS=TIB 0.037 0.704Color TIS=TIB 0.250 0.950Power TIS=TIB 0.247 0.945M TIB 0.153 0.724PW TIB 0.969 0.716Color-Triplex TIB 1.550 0.734Power-Triplex TIB 1.473 0.803
AppendicesT3300 Diagnostic Ultrasound System |116 | B00601-010 4/10/17GYNB TIS=TIB 0.030 0.773Color TIS=TIB 0.211 1.048Power TIS=TIB 0.208 1.039M TIB 0.213 0.798PW TIB 0.746 0.701Color-Triplex TIB 1.476 0.805Power-Triplex TIB 1.399 0.801NerveB TIS=TIB 0.012 0.619Color TIS=TIB 0.271 0.825Power TIS=TIB 0.249 0.823M TIB 0.164 0.643PW TIB 1.131 0.686Color-Triplex TIB 1.627 0.754Power-Triplex TIB 1.566 0.748Table 6 System Acoustic Output Default Table (C62B transducer)Preset Mode TI Label Default TI Default MI
AppendicesT3300 Diagnostic Ultrasound System |117 | B00601-010 4/10/1711.3.2 L154BH TransducerTable 7 System Acoustic Output Default Table (L154BH transducer)Preset Mode TI Label Default TI Default MICarotidB TIS=TIB 0.003 0.692Color TIS=TIB 0.162 1.222Power TIS=TIB 0.150 1.107M TIB 0.583 0.628PW TIB 0.172 0.796Color-Triplex TIB 0.872 0.576Power-Triplex TIB 1.031 0.754ArterialB TIS=TIB 0.043 0.692Color TIS=TIB 0.154 1.231Power TIS=TIB 0.187 1.125M TIB 0.186 0.845PW TIB 0.417 0.817Color-Triplex TIB 0.860 0.580Power-Triplex TIB 0.881 0.573VenousB TIS=TIB 0.006 0.685Color TIS=TIB 0.168 1.242Power TIS=TIB 0.171 1.125M TIB 0.488 0.628PW TIB 0.395 0.602Color-Triplex TIB 0.747 0.574Power-Triplex TIB 0.734 0.565ThyroidB TIS=TIB 0.008 0.685Color TIS=TIB 0.112 1.156Power TIS=TIB 0.108 1.123M TIB 0.530 0.614PW TIB 0.322 0.596Color-Triplex TIB 0.721 0.572Power-Triplex TIB 0.583 0.564BreastB TIS=TIB 0.004 0.681Color TIS=TIB 0.148 1.232Power TIS=TIB 0.138 1.140M TIB 0.181 0.611PW TIB 0.309 0.595Color-Triplex TIB 0.589 0.576Power-Triplex TIB 0.562 0.566
AppendicesT3300 Diagnostic Ultrasound System |118 | B00601-010 4/10/1711.3.3 P42B6 TransducerBowelB TIS=TIB 0.011 0.711Color TIS=TIB 0.212 1.278Power TIS=TIB 0.205 1.138M TIB 0.100 0.683PW TIB 0.363 0.591Color-Triplex TIB 1.379 0.572Power-Triplex TIB 0.545 0.563MSKB TIS=TIB 0.008 0.682Color TIS=TIB 0.222 1.247Power TIS=TIB 0.189 1.126M TIB 0.866 0.597PW TIB 0.436 0.594Color-Triplex TIB 0.729 0.596Power-Triplex TIB 0.670 0.567NerveB TIS=TIB 0.005 0.682Color TIS=TIB 0.146 1.249Power TIS=TIB 0.110 1.121M TIB 0.161 0.591PW TIB 0.308 0.593Color-Triplex TIB 0.624 0.596Power-Triplex TIB 0.408 0.568Table 8 System Acoustic Output Default Table (P42B6 transducer)Preset Mode TI Label Default TI Default MICardiacB TIS=TIB 0.193 1.280Color TIS=TIB 0.764 1.282Power TIS=TIB 0.874 1.282M TIB 1.079 1.386PW TIB 1.127 0.697CW TIB 1.761 0.062Color-Triplex TIB 2.261 0.994Power-Triplex TIB 2.245 0.992Table 7 System Acoustic Output Default Table (L154BH transducer)Preset Mode TI Label Default TI Default MI
AppendicesT3300 Diagnostic Ultrasound System |119 | B00601-010 4/10/1711.4 Appendix D: Acoustic Output Reporting Tables for Track 3We follow Track 3 of the FDA’s information for manufacturers seeking marketing clearance ofdiagnostic ultrasound systems and transducers. All table entries have been obtained at the sameoperating conditions that give rise to the maximum index value. Due to the complexities of thesystem user interface, it may be difficult to exactly replicate the declared condition. For moreinformation, contact BenQ Medical Technology.11.4.1 Definition of Terms Used in Acoustic Output TablesSymbols used in the tables are described below:: Acoustic attenuation coefficient is the coefficient intended to account for ultrasonic attenuation oftissue between the source and a specified point.Aaprt:-12 dB output beam area is the area of the ultrasonic beam derived from the -12 dB outputbeam dimensions.CMI: Normalizing coefficient 1 MPa MHz-1/2Deq: Equivalent aperture diameter is the diameter of a circle whose area is the -12dB output beamarea and given by Deq = .deq:Equivalent beam diameter is the value of the diameter of the acoustic beam at the distance z, interms of the equivalent beam area, and given by deq(z) = .fawf:Acoustic working frequency is the arithmetic mean of the most widely separated frequencies f1and f2 at which the amplitude of the pressure spectrum of the acoustic signal is 3 dB lower than thepeak amplitude.Ipa:Pulse-average intensity is the ratio of the pulse-intensity integral Ipi to the pulse duration td.Ipa, Į:Attenuated pulse-average intensity is the value of the acoustic pulse-average intensity afterattenuation and at a specified point and given by Ipa, Į = Ipa(z)10(-Įzfawf/10).Ispta:Spatial-peak temporal-average intensityIspta, Į:Attenuated spatial-peak temporal-average intensityMI:Mechanical index is given by MI = .npps:Number of pulses per ultrasonic scan lineP:Output power is the time-average power radiated by an ultrasonic transducer into anapproximately free field under specified conditions in a specified medium, preferably water.PĮ:Attenuated output power is the value of the acoustic output power after attenuation, at aspecified distance from the transducer, and given by pĮ = p10(-Įzfawf/10).pi:Pulse-pressure-squared integral is the time integral of the square of the instantaneous acousticpressure at a particular point in an acoustic field integrated over the acoustic pulse waveform.pii:Pulse-intensity integralpiiĮ:Attenuated Pulse-intensity integralpr:Peak-rarefactional acoustic pressure is the maximum of the modulus of the negativeinstantaneous acoustic pressure in an acoustic field during an acoustic repetition period.pr, Į:Attenuated peak-rarefactional acoustic pressure is the value of the peak-rarefactional acousticpressure after attenuation, at a specified point, and given by pr, Į+(z) = pr(z)10(-Įzfawf/20).D4S---Aaprt4S---Aeq zPrafawf 23e–CMI---------------------------
AppendicesT3300 Diagnostic Ultrasound System |120 | B00601-010 4/10/17prr:Pulse repetition rate is the inverse of the time interval between two successive acoustic pulses.srr:Scan repetition rateTI:Thermal index is the ratio of attenuated acoustic power at a specified point to the attenuatedacoustic power required to raise the temperature at that point in a specific tissue model by 1°C.TIB:Bone thermal index is the thermal index for applications, such as fetal (second and thirdtrimester) or neonatal cephalic (through the fontanelle), in which the ultrasound beam passesthrough soft tissue, and a focal region is in the immediate vicinity of bone.TIC: Cranial-bone thermal index is the thermal index for applications, such as pediatric and adult-cranial applications, in which the ultrasound beam passes through bone near the beam entranceinto the body.TIS:Soft-tissue thermal index is the thermal index related to soft tissues.td:Pulse duration is 1.25 times the interval between the time when the time integral of intensity in anacoustic pulse at a point reaches 10% and when it reaches 90% of the pulse-intensity integral.z: Distance from the source to a specified point.zb: Depth for TIB.zbp:Break-point depth is the value equal to 1.5 times the equivalent aperture diameter and given byzbp = 1.5Deq.zpii:Depth for peak pulse-intensity integral.zMI: Depth for MI.zpii, Į:Depth for peak attenuated pulse-intensity integral.zsii:Depth for peak sum of pulse-intensity integrals.zsii, Į:Depth for peak sum of attenuated pulse-intensity integrals.zs: Depth for TIS.
AppendicesT3300 Diagnostic Ultrasound System |121 | B00601-010 4/10/1711.4.2 Acoustic Output Tables for T3300 Transducers11.4.2.1 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (B-Mode)Control 1: Abdominal, B mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off, 2D Depth 5.5,2D Gain 44, Sector Width 70, Power 100, Freq GenControl 2: Abdominal, B mode, 2D Focus 8.0, Density Low, FQBeam off, SQBeam off, 2D Depth 9,2D Gain 44, Sector Width 46, Power 100, Freq PenTable 9 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (B-Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.0241 0.1925 0.1925 n/aIndex component value 0.1925 0.1925 0.1925 0.1925Acousticparameterspr,Į at zMI (MPa) 1.8359P (mW) 42.6 42.6 n/aP1x1 (mW) 13.5 13.5zs(cm) 0zb(cm) 0zMI (cm) 5.51zpii,Į(cm) 5.79fawf (MHz) 3.32 2.985 2.985 n/aOtherinformationprr (Hz) 166srr (Hz) 166npps 1Ipa,Į at zpii,Į(W/cm2)171.93Ispta,Į at zpii,Į or zsii,Į(mW/cm2)23.48Ispta at zpii or zsii (mW/cm2)84.2pr at zpii (MPa) 3.3539OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |122 | B00601-010 4/10/1711.4.2.2 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(Color Mode)Control 1: Abdominal, Color mode, ROI box minimized @ max depth, Focus 5.0, 2D/Color DensityLow, FQBeam off, SQBeam off, Depth 5.5, Gain 44, Sector Width 70, Power 100, 2D/Color Freq Pen, Color Scale 102cm/s Control 2: Abdominal, B/Color mode, ROI box minimized @ min depth, Focus 14.0, 2D/ColorDensity High, FQBeam off, SQBeam off,2D Depth 15, 2D Gain 44, Sector Width 46,Power 100, Freq 2D Pen/ ColorRes, Color Scale 42cm/ssTable 10 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.3343 1.0173 1.0173 n/aIndex component value 1.0173 1.0173 1.0173 1.0173Acousticparameterspr,Į at zMI (MPa) 1.8612P (mW) B: 8.54Col: 252.6 B: 8.54Col: 252.6 n/aP1x1 (mW) B: 2.81Col: 76.3 B: 2.81Col: 76.3zs(cm) 0zb(cm) 0zMI (cm) 5.05zpii,Į(cm) 5.57fawf (MHz) 2.058 B: 3.012Col: 2.688 B: 3.012Col: 2.688 n/aOther informationprr (Hz) 495srr (Hz) 45npps 11Ipa,Į at zpii,Į(W/cm2)117.7Ispta,Į at zpii,Įor zsii,Į(mW/cm2)23.04Ispta at zpii or zsii (mW/cm2)41.99pr at zpii (MPa) 2.5971OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |123 | B00601-010 4/10/1711.4.2.3 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(Power Mode)Control 1: Abdominal, Power mode, ROI box minimized @ max depth, Focus 5.0, 2D/CPA DensityLow, FQBeam off, SQBeam off, Depth 5.5, Gain 44, Sector Width 70, Power 100, 2D/CPAFreq Pen, CPA Scale PRF6Control 2: Abdominal, B/Power mode, ROI box minimized @ min depth, Focus 14.0, Density 2DLow/CPA High, FQBeam off, SQBeam off,2D Depth 15, 2D Gain 44, Sector Width 46,Power 100, Freq 2D Gen/ ColorRes, CPA Scale PRF3Table 11 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.3123 1.2129 1.2129 n/aIndex component value 1.2129 1.2129 1.2129 1.2129Acoustic parameterspr,Į at zMI (MPa) 1.8315P (mW) B: 8.55Power: 240 B: 8.55Power: 240 n/aP1x1 (mW) B: 2.59Power: 76.3 B: 2.59Power: 76.3zs(cm) 0zb(cm) 0zMI (cm) 5.07zpii,Į(cm) 5.79fawf (MHz) 2.058 B: 2.992Power: 3.24 B: 2.992Power: 3.24 n/aOtherinformationprr (Hz) 495srr (Hz) 45npps 11Ipa,Į at zpii,Į(W/cm2)112.31Ispta,Į at zpii,Įor zsii,Į(mW/cm2)25.07Ispta at zpii or zsii (mW/cm2)45.58pr at zpii (MPa) 2.5014OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |124 | B00601-010 4/10/1711.4.2.4 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (MMode)Control 1: Abdominal, M mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off, 2D Depth5.5, 2D Gain 44, Sector Width 128, Power 100, Freq GenControl 2: Abdominal, M mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off, 2D Depth5.5, 2D Gain 44, Sector Width 46, Power 100, Freq PenTable 12 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (M Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.0516 0.2309 0.4883 n/aIndex component value 0.1898 0.2309 0.1898 0.4883Acoustic parameterspr,Į at zMI (MPa) 2.0449P (mW) B: 31.2M: 9.14 B: 31.2M: 9.14 n/aP1x1 (mW) B: 9.75M: 2.56 B: 9.75M: 2.56zs(cm) 2.5zb(cm) 5.02zMI (cm) 5.43zpii,Į(cm) 5.85fawf (MHz) 3.89 B: 3.046M: 3.24 B: 3.046M: 3.24 n/aOtherinformationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)332.42Ispta,Į at zpii,Įor zsii,Į(mW/cm2)69.6Ispta at zpii or zsii (mW/cm2)278.9pr at zpii (MPa) 3.784OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |125 | B00601-010 4/10/1711.4.2.5 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (PWMode)Control 1: Abdominal, PW mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off,2D Depth5.5, 2D Gain 44, Sector Width 70, Power 100, Freq Pen, Filter 65HzControl 2: Abdominal, PW mode, 2D Focus 9, Density Low, FQBeam off, SQBeam off,2D Depth 10,2D Gain 44, Sector Width 128, Power 100, Freq Res, Filter 200HzTable 13 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (PW Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.2848 0.68 1.87 n/aIndex component value 0.519 0.68 0.519 1.871Acousticparameterspr,Į at zMI (MPa) 1.8557P (mW) 93.2 93.2 n/aP1x1 (mW) 33.9 33.9zs(cm) 3.34zb(cm) 6zMI (cm) 5.23zpii,Į(cm) 5.67fawf (MHz) 2.197 3.21 3.21 n/aOtherinformationprr (Hz) 1300srr (Hz) 1300npps 1Ipa,Į at zpii,Į(W/cm2)98.56Ispta,Į at zpii,Įor zsii,Į(mW/cm2)261.4Ispta at zpii or zsii (mW/cm2)528pr at zpii (MPa) 2.5817OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |126 | B00601-010 4/10/1711.4.2.6 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(Triplex Mode)Control 1: Abdominal, Triplex mode, ROI box flat wide @ max depth, Focus 5.0, SV 5.0, 2D/ColorDensity High, FQBeam off, SQBeam off, Depth 5.5, Gain 44, Sector Width 46, Power 100,2D/Color/PW Freq Pen, Color Scale 26cm/s, Wall Filter 65HzTable 14 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (Triplex Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.137 0.8799 1.6959 n/aIndex component value 0.7181 0.8799 0.7181 1.6959Acoustic parameterspr,Į at zMI (MPa) 1.586P (mW) B: 11.02Col: 106.2PW: 67.6B: 11.02Col: 106.2PW: 67.6 n/aP1x1 (mW) B: 3.33Col: 33.5PW: 20.3B: 3.33Col: 33.5PW: 20.3zs(cm) B/col: 0PW: 4.02zb(cm) B/col: 0PW: 4.64zMI (cm) 5.04zpii,Į(cm) 5.02fawf (MHz) 1.947 B: 3.145Col: 2.689PW: 2.474B: 3.145Col: 2.689PW: 2.474 n/aOtherinformationprr (Hz) 1300srr (Hz) 1300npps 1Ipa,Į at zpii,Į(W/cm2)92.2Ispta,Į at zpii,Įor zsii,Į(mW/cm2)246.7Ispta at zpii or zsii (mW/cm2)496pr at zpii (MPa) 2.18OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |127 | B00601-010 4/10/17Control 2: Abdominal, Triplex mode, ROI box minimized @ min depth, Focus 13.0, SV 13.0, 2D/Color Density High, FQBeam off, SQBeam off, Depth 14, Gain 44, Sector Width 46,Power 100, 2D/Color/PW Freq Gen/Res/Gen, Color Scale 28cm/s, Wall Filter 100Hz
AppendicesT3300 Diagnostic Ultrasound System |128 | B00601-010 4/10/1711.4.2.7 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (THIMode)Control 1: Abdominal, THI mode, Focus 5.0, Density Low, FQBeam off, SQBeam off, Depth 5.5,Gain 44, Sector Width 70, Power 100, Freq Gen Control 2: Abdominal, THI mode, Focus 8.0, Density Low, FQBeam off, SQBeam off, Depth 9, Gain44, Sector Width 46, Power 100, Freq ResTable 15 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (THI Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.2529 0.366 0.366 n/aIndex component value 0.366 0.366 0.366 0.366Acousticparameterspr,Į at zMI (MPa) 2.1868P (mW) 80.2 80.2 n/aP1x1 (mW) 24.7 24.7zs(cm) 0zb(cm) 0zMI (cm) 5.23zpii,Į(cm) 5.47fawf (MHz) 3.158 3.109 3.109 n/aOther informationprr (Hz) 166srr (Hz) 166npps 1Ipa,Į at zpii,Į(W/cm2)328.24Ispta,Į at zpii,Įor zsii,Į(mW/cm2)74.78Ispta at zpii or zsii (mW/cm2)223.66pr at zpii (MPa) 3.718OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |129 | B00601-010 4/10/1711.4.2.8 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(THI+Color Mode)Control 1: Abdominal, Color mode, ROI box minimized @ max depth, Focus 5.0, 2D/Color DensityLow, FQBeam off, SQBeam off, Depth 5.5, Gain 44, Sector Width 70, Power 100, 2D/Color Freq Pen, Color Scale 102cm/s Control 2: Abdominal, THI/Color mode, ROI box minimized @ min depth, Focus 14.0, THI/ColorDensity High, FQBeam off, SQBeam off,2D Depth 15, 2D Gain 44, Sector Width 46,Power 100, Freq 2D Pen/ ColorRes, PRF Scale 42cm/sTable 16 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (THI+Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.3376 1.0681 1.0681 n/aIndex component value 1.0681 1.0681 1.0681 1.0681Acousticparameterspr,Į at zMI (MPa) 1.8667P (mW) THI: 16.5Col: 250.3 THI: 16.5Col: 250.3 n/aP1x1 (mW) THI: 5Col: 78.3 THI: 5Col: 78.3zs(cm) 0zb(cm) 0zMI (cm) 5.07zpii,Į(cm) 5.61fawf (MHz) 2.057 THI: 2.691Col: 2.693 THI: 2.691Col: 2.6939 n/aOther informationprr (Hz) 495srr (Hz) 45npps 11Ipa,Į at zpii,Į(W/cm2)116.71Ispta,Į at zpii,Įor zsii,Į(mW/cm2)23.52Ispta at zpii or zsii (mW/cm2)42.66pr at zpii (MPa) 2.5839OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |130 | B00601-010 4/10/1711.4.2.9 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(THI+Power Mode)Control 1: Abdominal, Power mode, ROI box minimized @ max depth, Focus 5.0, 2D/CPA DensityLow, FQBeam off, SQBeam off, Depth 5.5, Gain 44, Sector Width 70, Power 100, 2D/CPAFreq Pen, CPA Scale PRF6 Control 2: Abdominal, THI/Power mode, ROI box minimized @ min depth, Focus 14.0, Density 2DLow/CPA High, FQBeam off, SQBeam off,2D Depth 15, 2D Gain 44, Sector Width 46,Power 100, Freq 2D Gen/ ColorRes, CPA Scale PRF3Table 17 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (THI+Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.3365 1.1025 1.1025 n/aIndex component value 1.1025 1.1025 1.1025 1.1025Acousticparameterspr,Į at zMI (MPa) 1.8656P (mW) THI: 15.9Power: 241.2 THI: 15.9Power: 241.2 n/aP1x1 (mW) THI: 5.1Power: 67 THI: 5.1Power: 67zs(cm) 0zb(cm) 0zMI (cm) 5.17zpii,Į(cm) 5.69fawf (MHz) 2.058 THI: 2.987Power: 3.23 THI: 2.987Power: 3.23 n/aOther informationprr (Hz) 495srr (Hz) 45npps 11Ipa,Į at zpii,Į(W/cm2)115.72Ispta,Į at zpii,Įor zsii,Į(mW/cm2)24.76Ispta at zpii or zsii (mW/cm2)44.97pr at zpii (MPa) 2.5619OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |131 | B00601-010 4/10/1711.4.2.10 Acoustic Output Reporting Table for Track 3 for the C62B Transducer(THI+M Mode)Control 1: Abdominal, THI/M mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off,2D Depth5.5, 2D Gain 44, Sector Width 128, Power 100, Freq Gen Control 2: Abdominal, THI/M mode, 2D Focus 5.0, Density Low, FQBeam off, SQBeam off,2D Depth5.5, 2D Gain 44, Sector Width 46, Power 100, Freq PenTable 18 Acoustic Output Reporting Table for Track 3 for the C62B Transducer (THI+M Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.2881 0.3806 0.638 n/aIndex component value 0.3395 0.3806 0.3395 0.638Acousticparameterspr,Į at zMI (MPa) 2.2759P (mW) THI: 62.4M: 9.14 THI: 62.4M: 9.14 n/aP1x1 (mW) THI: 19.5M: 2.56 THI: 19.5M: 2.56zs(cm) 2.5zb(cm) 5.02zMI (cm) 5.27zpii,Į(cm) 5.55fawf (MHz) 3.234 THI: 3.24M: 2.56 THI: 3.24M: 2.56 n/aOther informationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)426.8Ispta,Į at zpii,Įor zsii,Į(mW/cm2)102.8Ispta at zpii or zsii (mW/cm2)328pr at zpii (MPa) 3.883OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |132 | B00601-010 4/10/1711.4.2.11 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (B-Mode)Control 1: Carotid, B mode, 2D Focus 2.5, Density Low, SQBeam off, 2D Depth 3, 2D Gain 64,Sector Width 46, Power 100, Freq PenControl 2: Carotid, B mode, 2D Focus 5.5, Density High, SQBeam off, 2D Depth 6, 2D Gain 64,Sector Width 46, Power 100, Freq PenTable 19 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (B-Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 0.9603 0.2516 0.2516 n/aIndex component value 0.2516 0.2516 0.2516 0.2516Acousticparameterspr,Į at zMI (MPa) 2.4574P (mW) 12.49 12.49 n/aP1x1 (mW) 8.07 8.07zs(cm) 0zb(cm) 0zMI (cm) 2.03zpii,Į(cm) 2.07fawf (MHz) 6.7 6.55 6.55 n/aOther informationprr (Hz) 300.03srr (Hz) 300.03npps 1Ipa,Į at zpii,Į(W/cm2)376.2Ispta,Į at zpii,Įor zsii,Į(mW/cm2)17.24Ispta at zpii or zsii (mW/cm2)39.43pr at zpii (MPa) 3.74OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |133 | B00601-010 4/10/1711.4.2.12 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(Color Mode)Control 1: Carotid, Color mode, ROI box minimized @ max depth, Focus 2.5, 2D/Color Density Low/High, SQBeam off, Depth 3, Gain 64, Sector Width 46, Power 100, 2D/Color Freq Res,Color Scale 44cm/sControl 2: Carotid, B/Color mode, ROI box minimized @ min depth, Focus 7.5, 2D/Color DensityHigh, SQBeam off, 2D Depth 8, 2D Gain 64, Sector Width 46, Power 100, Freq 2D Pen/ColorGen, Color Scale 46cm/s, Steer 0Table 20 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.2595 1.4371 1.4371 n/aIndex component value 1.4371 1.4371 1.4371 1.4371Acousticparameterspr,Į at zMI (MPa) 3.1053P (mW) B: 3.18Col: 99.9 B: 3.18Col: 99.9 n/aP1x1 (mW) B: 1.67Col: 57.8 B: 1.67Col: 57.8zs(cm) 0zb(cm) 0zMI (cm) 1.79zpii,Į(cm) 1.93fawf (MHz) 6.23 B: 6.55Col: 5.03 B: 6.55Col: 5.03 n/aOther informationprr (Hz) 398.123srr (Hz) 36.193npps 11Ipa,Į at zpii,Į(W/cm2)704Ispta,Į at zpii,Įor zsii,Į(mW/cm2)13.27Ispta at zpii or zsii (mW/cm2)27.27pr at zpii (MPa) 4.191OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |134 | B00601-010 4/10/1711.4.2.13 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(Power Mode)Control 1: Carotid, Power mode, ROI box minimized @ max depth, Focus 2.5, 2D/CPA Density Low/High, SQBeam off, Depth 3, Gain 64, Sector Width 46, Power 100, 2D/CPA Freq Gen,CPA Scale PRF 7Control 2: Carotid, B/Power mode, ROI box minimized @ min depth, Focus 7.5, Density 2D Low/Color High, SQBeam off, 2D Depth 8, 2D Gain 64, Sector Width 46, Power 100, Freq 2DPen/ CPA Pen, CPA Scale PRF 4, Steer 0Table 21 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface Below SurfaceMaximum index value 1.2419 0.9966 0.9966 n/aIndex component value 0.9966 0.9966 0.9966 0.9966Acousticparameterspr,Į at zMI (MPa) 3.0591P (mW) B: 2.9Power: 57.2 B: 2.9Power: 57.2 n/aP1x1 (mW) B: 1.55Power: 39.48 B: 1.55Power: 39.4zs(cm) 0zb(cm) 0zMI (cm) 1.81zpii,Į(cm) 1.89fawf (MHz) 6.22 B: 6.59Power: 5.05 B: 6.59Power: 5.05 n/aOther informationprr (Hz) 398.123srr (Hz) 36.193npps 11Ipa,Į at zpii,Į(W/cm2)705.1Ispta,Į at zpii,Į or zsii,Į(mW/cm2)13.05Ispta at zpii or zsii (mW/cm2)26.87pr at zpii (MPa) 4.257OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |135 | B00601-010 4/10/1711.4.2.14 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (MMode)Control 1: Carotid, M mode, 2D Focus 2.5, Density Low, SQBeam off, 2D Depth 3, 2D Gain 64,Sector Width 128, Power 100, Freq PenControl 2: Carotid, M mode, 2D Focus 7.5, Density High, SQBeam off, 2D Depth 8, 2D Gain 64,Sector Width 46, Power 100, Freq PenTable 22 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (M Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 0.9999 0.14081 0.1794 n/aIndex component value 0.14081 0.1308 0.14081 0.1794Acousticparameterspr,Į at zMI (MPa) 2.6851P (mW) B: 10.7M: 0.5625 B: 10.7M: 0.5625 n/aP1x1 (mW) B: 3.9M: 0.5589 B: 3.9M: 0.5589zs(cm) 1.47zb(cm) 1.47zMI (cm) 1.92zpii,Į(cm) 2fawf (MHz) 7.35 B: 6.54M: 7.26 B: 6.54M: 7.26 n/aOther informationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)551.1Ispta,Į at zpii,Įor zsii,Į(mW/cm2)64.7Ispta at zpii or zsii (mW/cm2)159.2pr at zpii (MPa) 4.114OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |136 | B00601-010 4/10/1711.4.2.15 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(PW Mode)Control 1: Carotid, PW mode, 2D Focus 3, Density Low, SQBeam off, 2D Depth 3.5, 2D Gain 64,Sector Width 128, Power 100, Freq ResControl 2: Carotid, PW mode, 2D Focus 8.5, Density High, SQBeam off, 2D Depth 9, 2D Gain 64,Sector Width 256, Power 100, Freq ResTable 23 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (PW Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 0.9804 0.698 2.152 n/aIndex component value 0.698 0.676 0.698 2.152Acousticparameterspr,Į at zMI (MPa) 2.4264P (mW) 44.8 44.8 n/aP1x1 (mW) 23.9 23.9zs(cm) 1.56zb(cm) 1.56zMI (cm) 1.86zpii,Į(cm) 2.13fawf (MHz) 6.19 6.13 6.13 n/aOther informationprr (Hz) 1300srr (Hz) 1300npps 1Ipa,Į at zpii,Į(W/cm2)409.2Ispta,Į at zpii,Įor zsii,Į(mW/cm2)651.6Ispta at zpii or zsii (mW/cm2)1664.4pr at zpii (MPa) 3.6936OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |137 | B00601-010 4/10/1711.4.2.16 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(Triplex Mode)Control 1: Carotid, Triplex mode, ROI box flat wide @ max depth, Focus 2.5, SV 2.5, 2D/ColorDensity High, SQBeam off, Depth 3, Gain 64, Sector Width 46, Power 100, 2D/Color/PWFreq Pen/Res/Pen, Color Scale 8cm/s, Wall Filter 39Hz, Steer 0Table 24 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (Triplex Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 0.952 1.3865 3.0245 n/aIndex component value 1.3335 1.3865 1.3335 3.0245Acousticparameterspr,Į at zMI (MPa) 1.914P (mW) B: 3.54Col: 62.6PW: 36.8B: 3.54Col: 62.6PW: 36.8 n/aP1x1 (mW) B: 1.89Col: 33.5PW: 19.9B: 1.89Col: 33.5PW: 19.9zs(cm) B/col: 0PW: 1.47zb(cm) B/col: 0PW: 1.47zMI (cm) 1.42zpii,Į(cm) 1.55fawf (MHz) 4.04 B: 6.5Col: 5.02PW: 5B: 6.5Col: 5.02PW: 5 n/aOther informationprr (Hz) 1300srr (Hz) 1300npps 1Ipa,Į at zpii,Į(W/cm2)183.3Ispta,Į at zpii,Įor zsii,Į(mW/cm2)479Ispta at zpii or zsii (mW/cm2)755pr at zpii (MPa) 2.317OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |138 | B00601-010 4/10/17Control 2: Carotid, Triplex mode, ROI box minimized @ min depth, Focus 7.5, SV 7.5, 2D/ColorDensity High, SQBeam off, 2D Depth 8, 2D Gain 64, Sector Width 46, Power 100, 2D/Color/PW Freq Pen/Gen/Gen, Color Scale 10cm/s, Wall Filter 39Hz, Steer 0
AppendicesT3300 Diagnostic Ultrasound System |139 | B00601-010 4/10/1711.4.2.17 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(THI Mode)Control 1: Carotid, THI mode, 2D Focus 2.5, Density Low, SQBeam off, 2D Depth 3, 2D Gain 64,Sector Width 46, Power 100, Freq PenControl 2: Carotid, THI mode, 2D Focus 6.5, Density High, SQBeam off, 2D Depth 7, 2D Gain 64,Sector Width 46, Power 100, Freq PenTable 25 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (THI Mode)Index label MITIS TIBTICAtSurface Below Surface AtSurface BelowSurfaceMaximum index value 1.0351 0.2323 0.2323 n/aIndex component value 0.2323 0.2323 0.2323 0.2323Acousticparameterspr,Į at zMI (MPa) 2.464P (mW) 13.5 13.5 n/aP1x1 (mW) 9.1 9.1zs(cm) 0zb(cm) 0zMI (cm) 1.97zpii,Į(cm) 2.1fawf (MHz) 5.82 5.36 5.36 n/aOther informationprr (Hz) 300.03srr (Hz) 300.03npps 1Ipa,Į at zpii,Į(W/cm2)368.5Ispta,Į at zpii,Įor zsii,Į(mW/cm2)21.3882Ispta at zpii or zsii (mW/cm2)40.5836pr at zpii (MPa) 3.3594OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |140 | B00601-010 4/10/1711.4.2.18 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(THI+Color Mode)Control 1: Carotid, Color mode, ROI box minimized @ max depth, Focus 2.5, THI/Color DensityLow/High, SQBeam off, Depth 3, Gain 64, Sector Width Control 2: Carotid, THI/Color mode, ROI box minimized @ min depth, Focus 8.5, 2D/Color DensityHigh, SQBeam off, 2D Depth 9, 2D Gain 64, Sector Table 26 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (THI+Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.2496 1.5142 1.5142 n/aIndex component value 1.5142 1.5142 1.5142 1.5142Acousticparameterspr,Į at zMI (MPa) 3.08P (mW) THI: 4.58Col: 103.4 THI: 4.58Col: 103.4 n/aP1x1 (mW) THI: 2.43Col: 58 THI: 2.43Col: 58zs(cm) 0zb(cm) 0zMI (cm) 1.8zpii,Į(cm) 1.86fawf (MHz) 6.22 THI: 5.33Col: 5.04 THI: 5.33Col: 5.04 n/aOther informationprr (Hz) 398.123srr (Hz) 36.193npps 11Ipa,Į at zpii,Į(W/cm2)701.8Ispta,Į at zpii,Įor zsii,Į(mW/cm2)13.17Ispta at zpii or zsii (mW/cm2)27.14pr at zpii (MPa) 4.323OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |141 | B00601-010 4/10/1711.4.2.19 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(THI+Power Mode)Control 1: Carotid, Power mode, ROI box minimized @ max depth, Focus 2.5, 2D/CPA Density Low/High, SQBeam off, Depth 3, Gain 64, Sector Width 46, Power 100, 2D/CPA Freq Gen,CPA Scale PRF 7 Control 2: Carotid, THI/Power mode, ROI box minimized @ min depth, Focus 8.5, Density 2D High/Color High, SQBeam off, 2D Depth 9, 2D Gain 64, Sector Width 46, Power 100, Freq THIGen/ CPA Res, CPA Scale PRF 4, Steer 0Table 27 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (THI+Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.232 1.244 1.244 n/aIndex component value 1.244 1.244 1.244 1.244Acousticparameterspr,Į at zMI (MPa) 3.0349P (mW) THI: 8.28Power: 60.4 THI: 8.28Power: 60.4 n/aP1x1 (mW) THI: 3.96Power: 32.9 THI: 3.96Power: 32.9zs(cm) 0zb(cm) 0zMI (cm) 1.81zpii,Į(cm) 1.9fawf (MHz) 6.22 THI: 5.62Power: 7.26 THI: 5.62Power: 7.26 n/aOther informationprr (Hz) 398.123srr (Hz) 36.193npps 11Ipa,Į at zpii,Į(W/cm2)699.6Ispta,Į at zpii,Įor zsii,Į(mW/cm2)12.75Ispta at zpii or zsii (mW/cm2)26.3pr at zpii (MPa) 4.202OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |142 | B00601-010 4/10/1711.4.2.20 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer(THI+M Mode)Control 1: Carotid, THI/M mode, 2D Focus 2.5, Density Low, SQBeam off, 2D Depth 3, 2D Gain 64,Sector Width 128, Power 100, Freq PenControl 2: Carotid, THI/M mode, 2D Focus 7.5, Density High, SQBeam off, 2D Depth 8, 2D Gain 64,Sector Width 46, Power 100, Freq PenTable 28 Acoustic Output Reporting Table for Track 3 for the L154BH Transducer (THI+M Mode)Index label MITIS TIBTICAtSurface Below Surface AtSurface BelowSurfaceMaximum index value 1.3805 0.16429 0.2108 n/aIndex component value 0.16404 0.16429 0.16404 0.2108Acousticparameterspr,Į at zMI (MPa) 3.0987P (mW) THI: 11.6M: 0.5589 THI: 11.6M: 0.5589 n/aP1x1 (mW) THI: 6.1M: 0.2732 THI: 6.1M: 0.2732zs(cm) 1.47zb(cm) 1.47zMI (cm) 1.85zpii,Į(cm) 1.9fawf (MHz) 5.19 THI: 5.32M: 7.26 THI: 5.32M: 7.26 n/aOther informationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)660Ispta,Į at zpii,Įor zsii,Į(mW/cm2)110.3Ispta at zpii or zsii (mW/cm2)186.3pr at zpii (MPa) 3.828OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |143 | B00601-010 4/10/1711.4.2.21 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (B-Mode)Control 1: Cardiac, B mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain 45,Sector Width 62, Power 100, Freq GenControl 2: Cardiac, B mode, 2D Focus 5.0, Density Low, FQBeam off, 2D Depth 6, 2D Gain 45,Sector Width 70, Power 100, Freq ResTable 29 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (B-Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.0818 0.46 0.46 n/aIndex component value 0.46 0.46 0.46 0.46Acousticparameterspr,Į at zMI (MPa) 1.7784P (mW) 50.2 50.2 n/aP1x1 (mW) 43.3 43.3zs(cm) 0zb(cm) 0zMI (cm) 5.09zpii,Į(cm) 5.48fawf (MHz) 2.824 2.23 2.23 n/aOther informationprr (Hz) 275.86srr (Hz) 275.86npps 1Ipa,Į at zpii,Į(W/cm2)220.59Ispta,Į at zpii,Įor zsii,Į(mW/cm2)219.17Ispta at zpii or zsii (mW/cm2)346.37pr at zpii (MPa) 2.6955OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |144 | B00601-010 4/10/1711.4.2.22 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(Color Mode)Control 1: Cardiac, Color mode, ROI box minimized @ max depth, Focus 6.0, 2D/Color Density Low,FQBeam off, Depth 6.5, Gain 45, Sector Width 62, Power 100, 2D/Color Freq Gen, ColorScale 69cm/sControl 2: Cardiac, B/Color mode, ROI box minimized @ min depth, Focus 8.0, 2D/Color DensityHigh, FQBeam off, 2D Depth 9, 2D Gain 45, Sector Width 86, Power 100, Freq 2D Gen/ColorGen, Color Scale 61cm/sTable 30 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.1601 1.6911 1.6911 n/aIndex component value 1.6911 1.6911 1.6911 1.6911Acousticparameterspr,Į at zMI (MPa) 1.8333P (mW) B: 7Col: 234.2 B: 7Col: 234.2 n/aP1x1 (mW) B: 6.3Col: 138.3 B: 6.3Col: 138.3zs(cm) 0zb(cm) 0zMI (cm) 4.79zpii,Į(cm) 5.06fawf (MHz) 2.619 B: 2.036Col: 2.475 B: 2.036Col: 2.475 n/aOther informationprr (Hz) 435.732srr (Hz) 39.612npps 11Ipa,Į at zpii,Į(W/cm2)324.9Ispta,Į at zpii,Įor zsii,Į(mW/cm2)100.3Ispta at zpii or zsii (mW/cm2)202.06pr at zpii (MPa) 2.754OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |145 | B00601-010 4/10/1711.4.2.23 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(Power Mode)Control 1: Cardiac, Power mode, ROI box minimized @ max depth, Focus 6.0, 2D/Color DensityLow, FQBeam off, Depth 6.5, Gain 45, Sector Width 62, Power 100, 2D/Color Freq Gen,CPA Scale PRF 5Control 2: Cardiac, B/Power mode, ROI box minimized @ min depth, Focus 10.0, Density 2D Low/CPA High, FQBeam off, 2D Depth 11, 2D Gain 45, Sector Width 86, Power 100, Freq 2DGen/ CPARes, CPA Scale PRF 4Table 31 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.1637 1.26056 1.26056 n/aIndex component value 1.26056 1.26056 1.26056 1.26056Acousticparameterspr,Į at zMI (MPa) 1.8396P (mW) B: 1.16Power: 129.3 B: 1.16Power: 129.3 n/aP1x1 (mW) B: 0.71Power: 77.5 B: 0.71Power: 77.5zs(cm) 0zb(cm) 0zMI (cm) 4.82zpii,Į(cm) 5.03fawf (MHz) 2.618 B: 2.532Power: 3.39 B: 2.532Power: 3.39 n/aOther informationprr (Hz) 457.853srr (Hz) 41.623npps 11Ipa,Į at zpii,Į(W/cm2)326.7Ispta,Į at zpii,Įor zsii,Į(mW/cm2)109.024Ispta at zpii or zsii (mW/cm2)217.985pr at zpii (MPa) 2.7081OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |146 | B00601-010 4/10/1711.4.2.24 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (CWMode)Control 1: Cardiac, CW mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain 45,Sector Width 128, Power 100, Freq GenTable 32 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (CW Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 0.6048 0.606 2.259 n/aIndex component value 0.606 0.502 0.606 2.259Acousticparameterspr,Į at zMI (MPa) 0.0855P (mW) 69.8 69.8 n/aP1x1 (mW) 63.6 63.6zs(cm) 2.03zb(cm) 2.96zMI (cm) 3.23zpii,Į(cm) 3.53fawf (MHz) 2.12 2 2 n/aOther informationprr (Hz) n/asrr (Hz) n/anpps 1Ipa,Į at zpii,Į(W/cm2)0.24813Ispta,Į at zpii,Įor zsii,Į(mW/cm2)275.7Ispta at zpii or zsii (mW/cm2)431pr at zpii (MPa) 0.10629OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |147 | B00601-010 4/10/1711.4.2.25 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (MMode)Control 1: Cardiac, M mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain 45,Sector Width 128, Power 100, Freq GenControl 2: Cardiac, M mode, 2D Focus 7.0, Density Low, FQBeam off, 2D Depth 8, 2D Gain 45,Sector Width 70, Power 100, Freq GenTable 33 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (M Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.1412 0.6077 0.943 n/aIndex component value 0.6077 0.5861 0.6077 0.943Acousticparameterspr,Į at zMI (MPa) 1.9647P (mW) B: 49.1M: 12.6 B: 49.1M: 12.6 n/aP1x1 (mW) B: 33.61M: 9.4 B: 33.61M: 9.4zs(cm) 2.3zb(cm) 5zMI (cm) 4.85zpii,Į(cm) 5.09fawf (MHz) 3.086 B: 2.711M: 2.965 B: 2.711M: 2.965 n/aOther informationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)379.8Ispta,Į at zpii,Įor zsii,Į(mW/cm2)122.8Ispta at zpii or zsii (mW/cm2)351pr at zpii (MPa) 3.204OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |148 | B00601-010 4/10/1711.4.2.26 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (PWMode)Control 1: Cardiac, PW mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain 45,Sector Width 128, Power 100, Freq PenControl 2: Cardiac, PW mode, 2D Focus 8.0, Density Low, FQBeam off, 2D Depth 9, 2D Gain 45,Sector Width 70,Table 34 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (PW Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.0773 0.2972 1.915 n/aIndex component value 0.2641 0.2972 0.2641 1.915Acousticparameterspr,Į at zMI (MPa) 1.7055P (mW) 43.1 43.1 n/aP1x1 (mW) 27.6 27.6zs(cm) 2.36zb(cm) 4.76zMI (cm) 4.85zpii,Į(cm) 5.36fawf (MHz) 2.625 2.009 2.009 n/aOther informationprr (Hz) 5000srr (Hz) 5000npps 1Ipa,Į at zpii,Į(W/cm2)231.66Ispta,Į at zpii,Įor zsii,Į(mW/cm2)363Ispta at zpii or zsii (mW/cm2)616pr at zpii (MPa) 2.3076OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |149 | B00601-010 4/10/1711.4.2.27 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(Triplex Mode)Control 1: Cardiac, Triplex mode, ROI box flat wide @ max depth, Focus 6, SV 6, 2D/Color DensityTable 35 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (Triplex Mode)Index label MITIS TIBTICAtSurface Below Surface AtSurface Below SurfaceMaximum index value 1.262 1.0341 2.727 n/aIndex component value 0.9969 1.0341 0.9969 2.727Acousticparameterspr,Į at zMI (MPa) 1.786P (mW) B: 5.5Col: 108PW: 42.2B: 5.5Col: 108PW: 42.2 n/aP1x1 (mW) B: 2.6Col: 59.6PW: 26.4B: 2.6Col: 59.6PW: 26.4zs(cm) B/col: 0PW: 2.39zb(cm) B/col: 0PW: 4.85zMI (cm) 3.41zpii,Į(cm) 3.95fawf (MHz) 2.004 B: 2.775Col: 2.502PW: 2.008B: 2.775Col: 2.502PW: 2.008 n/aOther informationprr (Hz) 1300srr (Hz) 1300npps 1Ipa,Į at zpii,Į(W/cm2)170.4Ispta,Į at zpii,Į or zsii,Į(mW/cm2)395Ispta at zpiior zsii (mW/cm2)678pr at zpii (MPa) 2.237OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |150 | B00601-010 4/10/17High, FQBeam off, Depth 6.5, Gain 45, Sector Width 70, Power 100, 2D/Color/PW FreqGen/Gen/Pen, Color Scale 20cm/s, Wall Filter 91HzControl 2: Cardiac, Triplex mode, ROI box minimized @ min depth, Focus 9, SV 9, 2D/Color DensityHigh, FQBeam off, 2D Depth 10, 2D Gain 45, Sector Width 46, Power 100, 2D/Color/PWFreq Res/Gen/Pen, Color Scale 30cm/s, Wall Filter 140Hz
AppendicesT3300 Diagnostic Ultrasound System |151 | B00601-010 4/10/1711.4.2.28 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (THIMode)Control 1: Cardiac, THI mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain 45,Sector Width 62, Power 100, Freq GenControl 2: Cardiac, THI mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 7, 2D Gain 45,Sector Width 70, Power 100, Freq ResTable 36 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (THI Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.3338 0.742 0.742 n/aIndex component value 0.742 0.742 0.742 0.742Acousticparameterspr,Į at zMI (MPa) 1.8243P (mW) 94 94 n/aP1x1 (mW) 73.2 73.2zs(cm) 0zb(cm) 0zMI (cm) 3.86zpii,Į(cm) 4.19fawf (MHz) 1.99 2.129 2.129 n/aOtherinformationprr (Hz) 275.7srr (Hz) 137.85npps 2Ipa,Į at zpii,Į(W/cm2)158.85Ispta,Į at zpii,Į or zsii,Į(mW/cm2)211.15Ispta at zpii or zsii (mW/cm2)319.24pr at zpii (MPa) 2.1906OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |152 | B00601-010 4/10/1711.4.2.29 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(THI+Color Mode)Control 1: Cardiac, Color mode, ROI box minimized @ max depth, Focus 6.0, 2D/Color Density Low,FQBeam off, Depth 6.5, Gain 45, Sector Width 62, Power 100, 2D/Color Freq Gen, ColorScale 69cm/sControl 2: Cardiac, THI/Color mode, ROI box minimized @ min depth, Focus 8.0, 2D/Color DensityHigh, FQBeam off, 2D Depth 9, 2D Gain 45, Sector Width 86, Power 100, Freq 2D Gen/ColorGen, Color Scale 61cm/sTable 37 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (THI+Color Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.1808 2.0127 2.0127 n/aIndex component value 2.0127 2.0127 2.0127 2.0127Acousticparameterspr,Į at zMI (MPa) 1.8675P (mW) B: 35.6Col: 262.4 B: 35.6Col: 262.4 n/aP1x1 (mW) B: 20.8Col: 154.9 B: 20.8Col: 154.9zs(cm) n/a n/azb(cm)zMI (cm) 4.76zpii,Į(cm) 5.18fawf (MHz) 2.62 THI: 1.885Col: 2.475 THI: 1.885Col: 2.475 n/aOtherinformationprr (Hz) 435.732srr (Hz) 39.612npps 11Ipa,Į at zpii,Į(W/cm2)324.9Ispta,Į at zpii,Į or zsii,Į(mW/cm2)104.317Ispta at zpii or zsii (mW/cm2)208.415pr at zpii (MPa) 2.6424OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |153 | B00601-010 4/10/1711.4.2.30 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(THI+Power Mode)Control 1: Cardiac, Power mode, ROI box minimized @ max depth, Focus 6.0, 2D/Color DensityLow, FQBeam off, Depth 6.5, Gain 45, Sector Width 62, Power 100, 2D/Color Freq Gen,CPA Scale PRF 5Control 2: Cardiac, THI/Power mode, ROI box minimized @ min depth, Focus 8.0, Density 2D Low/CPA High, FQBeam off, 2D Depth 9, 2D Gain 45, Sector Width 86, Power 100, Freq 2DRes/ CPAGen, CPA Scale PRF 4Table 38 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (THI+Power Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.1718 1.6591 1.6591 n/aIndex component value 1.6591 1.65917 1.6591 1.6591Acoustic parameterspr,Į at zMI (MPa) 1.8522P (mW) THI: 44Power: 203.2 THI: 44Power: 203.2 n/aP1x1 (mW) THI: 25.7Power: 119 THI: 25.7Power: 119zs(cm) 0zb(cm) 0zMI (cm) 4.79zpii,Į(cm) 5.12fawf (MHz) 2.619 THI: 2.101Power: 2.475 THI: 2.101Power: 2.475 n/aOtherinformationprr (Hz) 457.853srr (Hz) 41.623npps 11Ipa,Į at zpii,Į(W/cm2)324Ispta,Į at zpii,Į or zsii,Į(mW/cm2)108.18Ispta at zpiior zsii(mW/cm2)216.13pr at zpii (MPa) 2.6604OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |154 | B00601-010 4/10/1711.4.2.31 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer(THI+M Mode)Control 1: Cardiac, THI/M mode, 2D Focus 6.0, Density Low, FQBeam off, 2D Depth 6.5, 2D Gain45, Sector Width 128, Power 100, Freq GenControl 2: Cardiac, THI/M mode, 2D Focus 7.0, Density Low, FQBeam off, 2D Depth 8.0, 2D Gain45, Sector Width 70, Power 100, Freq GenTable 39 Acoustic Output Reporting Table for Track 3 for the P42B6 Transducer (THI+M Mode)Index label MITIS TIBTICAtSurface BelowSurface AtSurface BelowSurfaceMaximum index value 1.4238 0.6226 0.933 n/aIndex component value 0.5999 0.6226 0.5999 0.933Acoustic parameterspr,Į at zMI (MPa) 1.9224P (mW) THI: 88.5M: 11.4 THI: 88.5M: 11.4 n/aP1x1 (mW) THI: 58.3M: 5.5 THI: 58.3M: 5.5zs(cm) 2.3zb(cm) 5zMI (cm) 3.95zpii,Į(cm) 4.25fawf (MHz) 1.944 THI: 1.882M: 2.973 THI: 1.882M: 2.973 n/aOtherinformationprr (Hz) 250srr (Hz) 250npps 1Ipa,Į at zpii,Į(W/cm2)185.67Ispta,Į at zpii,Į or zsii,Į(mW/cm2)103.1Ispta at zpiior zsii (mW/cm2)158.3pr at zpii (MPa) 2.2644OperatingcontrolconditionsControl 1 MIControl 2 TIS TIBControl 3Control 4
AppendicesT3300 Diagnostic Ultrasound System |155 | B00601-010 4/10/1711.5 Appendix E: FCC Statement11.5.1 Federal Communications Commission (FCC) Statement15.21You are cautioned that changes or modifications not expressly approved by the part responsible forcompliance could void the user's authority to operate the equipment.15. 105(b)This equipment has been tested and found to comply with the limits for a Class B digital device,pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protectionagainst harmful interference in a residential installation.This equipment generates uses and can radiate radio frequency energy and, if not installed andused in accordance with the instructions, may cause harmful interference to radio communications.However, there is no guarantee that interference will not occur in a particular installation. If thisequipment does cause harmful interference to radio or television reception, which can bedetermined by turning the equipment off and on, the user is encouraged to try to correct theinterference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected.• Consult the dealer or an experienced radio/TV technician for help.This device complies with part 15 of the FCC Rules. Operation is subject to the following twoconditions:1. This device may not cause interference and2. This device must accept any interference, including interference that may cause undesiredoperation of the device.RF Radiation Exposure Statement:1. This transmitter must not be co-located or operating in conjunction with any other antenna ortransmitter.2. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolledenvironment. This equipment should be installed and operated with a minimum distance of 20centimeters between the radiator and your body.*CEStatement regarding the disposal of T3300 products containing electronic components:As a company, T3300 is committed to sustainable business practices, which are aimed to preserve,protect and improve the quality of the environment. We apply these to product technologies, design and the selection of the materials used in our products. Adhering to corresponding environmentallaws, directives and guidelines are a core element of our sustainability principles. Since the T3300concept is equipped with electronic components, we will ensure that it complies with actual orplanned directives and laws, which are mandatory for electronic products and may require specificmeasures regarding labeling, collection and recycling.NOTE: If not disposed of properly, batteries can be harmful. Protect the environment by takingexhausted batteries to authorized disposal stations.European Commission (CE) StatementEuropean Union Regulatory Notice
AppendicesT3300 Diagnostic Ultrasound System |156 | B00601-010 4/10/17This device bearing the CE marking is compliance with the essential requirements and otherrelevant provisions of Directive 2004/108/EC, 2014/53/EU, 2011/65/EU, 2012/19/EU and 93/42/EEC.This device complies with the following harmonized European standards:EMC: EN55022, EN55024Radio: EN300328,EN301893,EN301489-1,EN301489-17, EN62311Medical: IEC 60601-1, EN60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, EN ISO10993-1,EN ISO10993-5, EN ISO10993-10, EN ISO 14971ROHS: EN50581The following CE marking is valid for EU harmonized telecommunications products.
B00601-010 4/10/17BenQMedicalTech.com© 2017 BenQ Medical Technology Corporation.All rights reserved. Rights of modification reserved.

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