FCC ID: QQGBU2073J Bluetooth Adaptor

 

Setting Up a Wireless Network for the M-Turbo or S Series Ultrasound System Introduction ToarchivewirelesslyfromtheMTurboorS Seriesultrasoundsystem,SonoSitesupportsthenetworksetup describedinthisdocument.Usethesetupinstructionsfromtheroutermanufacturerforgeneralinformationonly. Afterconnectingtheultrasoundsystem,youneedtoconfigurealocationthroughtheConnectivitysetuppageon theultrasoundsystemandtoconnectthewirelessUSBdongle.Forinstructionstoconfigurealocation,seeoneof thefollowing:

DICOMforMTurboorS SeriesUltrasoundSystemUserGuide SiteLinkImageManager4.1.0UserGuideandSupplementP0816801 Formoreinformationabouttheultrasoundsystem,seetheultrasoundsystemuserguide. AdditionalcopiesofthesedocumentsareavailableonSonoSitesWebsiteatwww.sonosite.com. WARNING:

The wireless USB dongle is a radio transmitter designed for use as a mobile device as defined by the Federal Communications Commission

(FCC). Do not place the transmitter on a patients or users body. Ensure that the transmitter is located at least 20 cm (8 in) from a patients or users body. Locating the transmitter closer than 20 cm (8 in) to a persons body voids the users FCC authority to operate the equipment. Caution:

Operating the wireless USB dongle without a regulatory label or the correct country stamp is illegal. See the documentation from the manufacturer of the wireless USB dongle. To avoid damage to the wireless USB dongle when using the MDSm or MDS Lite II, remove or insert the USB dongle only when the system is in the stand. For environmental operating and storage specifications, see the operating instructions from the router manufacturer. System and hardware requirements MTurboorS Seriesultrasoundsystem(1.2orlater) SparkLANWireless802.11gUSBDongle AdditionalhardwarerequirementsforSiteLinkImageManager:

LinkSysWRT54GSWirelessGBroadbandRouter WebbrowseronthePC(forexample,InternetExplorer) Connecting the ultrasound system Toarchivewirelessly,youcanconnecttheultrasoundsysteminoneoftwoways:

Toanexistingwirelessnetwork Totherouter,whichisconnectedtothePC Ifconnectingtoanexistingwirelessnetwork(thetypicalsetupforDICOMusers),youdonotneedthe router.DICOMsetuprequiresawirelessaccesspointonanexistingwirelessnetworkwithaDICOMserver. Seeyournetworkadministrator. To connect and configure the router AC AC M-Turbo Wireless USB dongle Router Ethernet PC Figure 1 The ultrasound system connects to the router, which is connected to the PC Note: Notetheinformationenteredwhenconfiguringtherouter.Youneedthesameinformationtoconfigurethe ultrasoundsystem. 1 TurnoffthePCandtheultrasoundsystem. 2 Removethestickerfromthebackoftherouter,andconnecttheEthernetcabletoport1,2,3,or4(See Figure 2)andtoanEthernetportonthePC.(DonotconnecttheEthernetcabletotheInternetporton therouter.) 3 ConnectthepoweradaptertothePowerportonthebackoftherouter,andconnecttoanoutlet. ThepowerLCDandtheEthernetLCDonthefrontoftherouterlightup. Internet 1 2 3 4 Power Reset Ethernet cable Power adapter Figure 2 Router Ethernet ports and Power port 4 TurnonthePC,andstartaWebbrowser(forexample,InternetExplorer). 5 Intheaddressboxatthetopofthebrowser,type http://192.168.1.1 andthenpresstheENTER key. 6 Inthedialogboxthatappears,type admin inthePasswordfield.(TheUsernamefieldisempty.) 7 ClickOK.TheLinksyssetupwizardstarts. 2 8 IntheNetwork Setup section,selectDisableforDHCP Server.SeeFigure 3. Figure 3 Network setup for the router 9 MakesurethattheTime Zone settingiscorrect. 10 ClickSave Settings. 11 Click Continue 12 ClicktheWirelesstab. TheWirelesspageappears.SeeFigure 4. Figure 4 Wireless Network Mode and Name (SSID) 3 13 IntheWireless Network Modelist,selectMixed. 14 ForWireless Network Name (SSID),typeauniquenameofupto32characters. Thisfieldiscasesensitiveandallowsnumbers.Youwillneedthisnamelaterwhenconfiguringthe ultrasoundsystem. 15 SelectasettingfromtheWireless Channellist. 16 ClickSave Settings. 17 ClickContinue. 18 ClickWireless Security. 19 Setupthesecuritypolicy.Forexample:

a ForSecurity Mode,selecttheWPA Personal.SeeFigure 5. b ForWPA Algorithms,selectTKIP. c EnteraWPAsharedkey.(TheWiFiProtectedAccessencryptedkeyprotectsagainstunauthorized networkaccess.Youwillneedthiskeylaterwhenconfiguringtheultrasoundsystem.) d TypeavalueforGroup Key Renewal (orkeepthedefaultsetting). Figure 5 Set up the security policy 20 ClickSave Settings. Thesetupiscomplete.Youcannowimportclientcertificatesandconfigurealocationontheultrasound system.SeetheSiteLinkImageManager4.1.0UserGuideandSupplementP0816801. Forsecurity,changetherouterpassword(ontheAdministrationtab)afterconfiguringtheultrasound system. 4 Client certificates Althoughyoucanconnectwithoutclientcertificates,theyhelptoensurenetworksecurity. To import or delete wireless certificates ThesystemsupportsBase64andDERencodedformatandthefollowingfiletypes:CER,PFX,andPVK. 1 OntheConnectivitysetuppage,selectWireless Certificates. Alistofcertificatesonthesystemappears. 2 Dooneofthefollowing:

Importcertificates:InserttheUSBstoragedevicethatcontainsthecertificates.Verifythatthe certificatesonthesystemplusthoseontheUSBstoragedevicedonotexceed20certificatesor200K ofmemory.Deletecertificatesifnecessary.ThenselectImportonscreen. Deletecertificates:Selectthecertificatestodelete,andselectDelete. Note: Youcanobtaincertificatesfromyournetworkadministrator. 3 SelectBackonscreen. 4 SelectDoneonscreen. 5 Restartthesystem. Connecting the wireless USB dongle Afteryouconnectandconfiguretherouter(ifapplicable)andconfigurealocationontheultrasound system,connectthewirelessUSBdongle,whichtransmitsthesignalfromtheultrasoundsystemtothe network. To connect the wireless USB dongle

InsertthewirelessUSBdongleintothefollowingUSBport:

(SSeries)TheUSBportonthesideoftheultrasoundsystem.

(MTurbo)AnyUSBportontheultrasoundsystem. Thesystemautomaticallydetectsthedevice.(Driversarealreadyinstalled.) Troubleshooting Ifyouhavetroubleconnectingtheultrasoundsystemtothewirelessnetwork,seeTable 1, Troubleshootingonpage 6forsuggestions.Ifthetroublecontinues,contactSonoSite:

SonoSite Technical Support Phone (US or Canada):

877-657-8118 Phone (Outside US and Canada):

425-951-1330 Or call your local representative. Fax:

E-mail:

425-951-6700 service@sonosite.com Web site:

www.sonosite.com (Click Resources > Support & Service) Europe Service Center Phone:

E-mail:

+44-(0)1462-444-800 uk.service@sonosite.com 5 Table 1: Troubleshooting Symptom Solution Theultrasoundsystem doesnotconnect.

Doanyofthefollowingforinformationaboutthenetwork:

Makesurethatthefollowingiconsappearinthesystemstatusarea ontheultrasoundsystemscreen:

Wireless Ultrasoundconnected Ontheultrasoundsystem,displaytheNetworkStatussetuppage. Thepagedisplaysthreelinesofgeneralinformationaboutthe connectionandfiveadditionallinesaboutthewirelessconnection(if present).

Doanyofthefollowing Makesurethatthesystemiscommunicatingwithyouraccesspoint:

Makesurethatthenetworknameonthesystemisthesameasthe networkname(SSID)oftheaccesspoint.Thedefaultnetworkname isSONOSITE.Thenetworknameiscasesensitive. IfyouuseWEPorWPAPSK,makesurethatyourWEPkeysorWPA PreSharedkeymatchbetweentheaccesspointandultrasound system.Thesekeysarecasesensitive. TheNetworkStatussetuppagemayshowthatyouassociated successfully,butyouareunabletogetaDHCPaddressbecausethe WEPkeyissetincorrectly. Ifyouselectthe802.1xRADIUSsecurityoption,makesurethatthe accesspointisturnedonandproperlyconfiguredwith802.1x enabledandthattheSharedSecretkeybetweentheaccesspointand authenticationservermatch. UsethePINGutilityfromtheservertomakesurethatthe authenticationserverisactiveandcancommunicatewiththeaccess point. 1 RemovethewirelessUSBdongle. 2 Verifythefollowing:

Allwirelesssettingsfortheselectedlocationarevalid. TheselectedwirelesscertificateisinBase64format. Thesystemdateandtimearecorrect. 3 InsertthewirelessUSBdongle,andrestartthesystem.

MakesurethattheDICOMsetupiscorrect.SeeDICOMforMTurboand S SeriesUserGuide.

MakesurethattheUSBstoragedevicecontainswirelesscertificatesby viewingitscontentsonaPC. Theultrasoundsystem doesnotauthenticate, andthewirelessicon doesnotappearon screen. Thesystemdoesnot displaythewirelessicon afteryouselectavalid location. Thesystemdisplaysthe wirelessiconbutdoes notcommunicatewith DICOM. Youcannotimport wirelesscertificates. 6 7 M-Turbo, S Series, SiteLink, SonoSite, and the SonoSite logo are either trademarks or registered trademarks of SonoSite, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. The SonoSite product(s) referenced in this document may be covered by one or more of the following U.S. patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, 7449640, D456509, D461895, D509900, D538432, D544962, D558351, D559390, and by the following counterpart foreign patents: AU727381, AU730822, CA2373065, CN98106133.8, CN98108973.9, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, FR0875203, FR0881492, FR0815793, FR1180970, FR1175713, GB0875203, GB0881492, GB0815793, GB1180970, GB1180971, GB1175713, IT0881492, IT0815793, IT1175713, KR532359, KR528102, NO326202, NZ542968, RCD000897368-0001, SP0881492, SP0815793. Patents pending. Caution:

Federal (United States) law restricts this device to sale by or on the order of a physician. SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin, Herts SG4 0AP UK T: +44-1462-444800 F: +44-1462-444801 01/2009 Copyright 2009 by SonoSite, Inc. All rights reserved. P12062-02

*P12062-02*

8

 

 

User Guide Supplement P09197-01 M-Turbo Ultrasound System User Guide S Series Ultrasound System User Guide ThisuserguidesupplementprovidesFederalCommunicationCommission(FCC)regulatoryinformation regardingusingtheMTurboultrasoundsystemorS Seriesultrasoundsystemtoperformwireless operations. Safety FCC Interference Statement ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuant toPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmful interferenceinaresidentialinstallation.Thisequipmentgenerates,usesandcanradiateradiofrequency energyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterference toradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticular installation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcan bedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterference byoneormoreofthefollowingmeasures:

Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected. ConsultSonoSiteforhelp. FCC Caution:Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliance couldvoidyourauthoritytooperatetheequipment. Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:

Thisdevicemaynotcauseharmfulinterference Thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesired operation. SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201 P09197-01 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin, Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801 03/2009 Copyright 2009 by SonoSite, Inc. All rights reserved.

*P09197-01*

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TM M-Turbo Ultrasound System User Guide TM M-Turbo Ultrasound System User Guide SonoSite,Inc. 2191930thDriveSE Bothell,WA98021 USA T:18884829449or14259511200 F:14259511201 SonoSiteLtd AlexanderHouse 40AWilburyWay Hitchin HertsSG40AP UK T:+441462444800 F:+441462444801 Caution:

Federal (United States) law restricts this device to sale by or on the order of a physician. M-Turbo, SiteLink, SonoCalc, SonoHD, SonoSite, and the SonoSite logo are registered trademarks or trademarks of SonoSite, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite product(s) referenced in this document may be covered by one or more of the following US patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, D456509, D461895, D509900, D538432, D544962, D558351, D559390, and by the following counterpart foreign patents: AU727381, AU730822, CA2373065, CN98106133.8, CN98108973.9, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, FR0875203, FR0881492, FR0815793, FR1180970, FR1175713, GB0875203, GB0881492, GB0815793, GB1180970, GB1180971, GB1175713, IT0881492, IT0815793, IT1175713, KR532359, KR528102, NZ542968, RCD000897368-0001, SP0881492, SP0815793. Patents pending. P0766202 10/2008 Copyright2008bySonoSite,Inc. Allrightsreserved ii Contents Introduction Conventions, symbols, and terms ......................................................................... vii Customer comments .................................................................................................. vii Chapter 1: Getting Started About the system .......................................................................................................... 1 Preparing the system ................................................................................................... 1 Installing or removing the battery ................................................................. 1 Using AC power and charging the battery ................................................. 2 Turning the system on or off ............................................................................ 3 Connecting transducers .................................................................................... 3 Inserting and removing USB storage devices ............................................ 4 System controls .............................................................................................................. 5 Screen layout .................................................................................................................. 7 General interaction ....................................................................................................... 8 Touchpad and cursor .......................................................................................... 8 On-screen options ............................................................................................... 8 Annotation and text ............................................................................................ 9 Preparing transducers ...............................................................................................10 Training videos .............................................................................................................11 Intended uses ...............................................................................................................11 Chapter 2: System Setup Displaying the setup pages .....................................................................................15 Restoring default settings ........................................................................................15 A & B Key, Footswitch setup ....................................................................................15 Administration setup .................................................................................................15 Security settings .................................................................................................16 User setup .............................................................................................................16 Exporting or importing user accounts .......................................................17 Exporting and clearing the Event log .........................................................17 Logging in as user ..............................................................................................18 Choosing a secure password .........................................................................18 Annotations setup ......................................................................................................18 Audio, Battery setup ...................................................................................................19 Cardiac Calculations setup ......................................................................................19 Connectivity setup ......................................................................................................19 Date and Time setup ..................................................................................................20 Display Information setup ........................................................................................20 IMT Calculations setup ..............................................................................................20 Network Status setup .................................................................................................20 iii OB Calculations setup ................................................................................................ 20 OB Custom Measurements setup .......................................................................... 21 OB Custom Tables setup ........................................................................................... 22 Presets setup ................................................................................................................. 22 System Information setup ........................................................................................ 23 USB Devices setup ...................................................................................................... 23 Limitations of JPEG format ............................................................................. 23 Chapter 3: Imaging Imaging modes ............................................................................................................ 25 2D imaging ........................................................................................................... 25 M Mode imaging ................................................................................................ 26 CPD and color Doppler imaging ................................................................... 27 PW and CW Doppler imaging ........................................................................ 28 Adjusting depth and gain ........................................................................................ 30 Freezing, viewing frames, and zooming ............................................................. 30 Imaging modes and exams available by transducer ...................................... 31 Annotating images ..................................................................................................... 32 Patient information form .......................................................................................... 33 Images and clips .......................................................................................................... 35 Saving images and clips .................................................................................. 35 Reviewing patient exams ............................................................................... 36 Printing, exporting, and deleting images and clips ............................... 37 ECG Monitoring ............................................................................................................ 38 Chapter 4: Measurements and Calculations Measurements .............................................................................................................. 41 Working with calipers ....................................................................................... 41 2D measurements .............................................................................................. 42 M Mode measurements ................................................................................... 43 Doppler measurements ................................................................................... 43 General calculations ................................................................................................... 45 Calculations menu ............................................................................................. 45 Performing and saving measurements in calculations ...................................................................................................... 45 Displaying, repeating, and deleting saved measurements in calculations .......................................................... 46 EMED calculations .............................................................................................. 46 Percent reduction calculations ...................................................................... 46 Volume calculations .......................................................................................... 48 Volume flow calculations ................................................................................ 48 Exam-based calculations .......................................................................................... 50 Cardiac calculations .......................................................................................... 50 Gynecology (Gyn) calculations ...................................................................... 58 IMT calculations .................................................................................................. 59 OB calculations ................................................................................................... 61 iv Small Parts calculations ....................................................................................64 Transcranial Doppler and Orbital calculations ........................................65 Vascular calculations .........................................................................................67 Patient report ................................................................................................................68 Vascular and cardiac patient reports ...........................................................69 TCD patient report .............................................................................................69 OB patient report ...............................................................................................69 EMED worksheets ...............................................................................................70 Chapter 5: Troubleshooting and Maintenance Troubleshooting ..........................................................................................................71 Software licensing .......................................................................................................71 Maintenance .................................................................................................................72 Cleaning and disinfecting the ultrasound system .................................73 Cleaning and disinfecting transducers .......................................................74 Cleaning and disinfecting the battery .......................................................75 Cleaning the footswitch ...................................................................................75 Cleaning and disinfecting ECG cables ........................................................76 Recommended disinfectants ..................................................................................77 Chapter 6: Safety Ergonomic safety .........................................................................................................85 Position the system ...........................................................................................86 Position yourself .................................................................................................86 Take breaks, exercise, and vary activities ...................................................87 Electrical safety classification ..................................................................................87 Electrical safety .............................................................................................................88 Equipment safety ........................................................................................................90 Battery safety ................................................................................................................90 Clinical safety ................................................................................................................92 Hazardous materials ...................................................................................................93 Electromagnetic compatibility ...............................................................................93 Manufacturers declaration .............................................................................94 ALARA principle ...........................................................................................................97 Applying ALARA .................................................................................................98 Direct controls .....................................................................................................98 Indirect controls ..................................................................................................99 Receiver controls ................................................................................................99 Acoustic artifacts .........................................................................................................99 Guidelines for reducing MI and TI .........................................................................99 Output display ........................................................................................................... 102 MI and TI output display accuracy ............................................................ 103 Factors that contribute to display uncertainty ..................................... 103 Related guidance documents ..................................................................... 104 Transducer surface temperature rise ................................................................ 104 Acoustic output measurement ............................................................................ 105 v In Situ, derated, and water value intensities ...........................................105 Tissue models and equipment survey ......................................................106 Acoustic output tables ............................................................................................107 Terms used in the acoustic output tables ...............................................132 Acoustic measurement precision and uncertainty ..............................133 Labeling symbols ......................................................................................................134 Chapter 7: References Measurement accuracy ...........................................................................................139 Sources of measurement errors ...........................................................................140 Measurement publications and terminology .................................................141 Cardiac references ............................................................................................141 Obstetrical references .....................................................................................145 Gestational age tables ....................................................................................146 Growth analysis tables ...................................................................................148 Ratio calculations .............................................................................................149 General references ...........................................................................................149 Chapter 8: Specifications Dimensions ..................................................................................................................153 System ..................................................................................................................153 Display ..................................................................................................................153 Supported transducers ...........................................................................................153 Imaging modes ..........................................................................................................153 Image and clip storage ............................................................................................153 Accessories ..................................................................................................................153 Peripherals ..........................................................................................................154 Temperature and humidity limits ........................................................................154 Operating ............................................................................................................154 Shipping and storage .....................................................................................154 Electrical .......................................................................................................................154 Battery ...........................................................................................................................154 Electromechanical safety standards ...................................................................154 EMC standards classification .................................................................................155 Airborne equipment standards ............................................................................155 DICOM standard ........................................................................................................155 HIPAA standard ..........................................................................................................155 Glossary Terms .............................................................................................................................157 Abbreviations .............................................................................................................159 Index ...........................................................................................................................169 vi I n t r o d u c t i o n Customer comments Questionsandcommentsareencouraged. SonoSiteisinterestedinyourfeedbackregarding thesystemandtheuserguide.Pleasecall SonoSiteat8884829449intheUS.Outsidethe US,callthenearestSonoSiterepresentative.You canalsoemailSonoSite at comments@sonosite.com. Fortechnicalsupport,pleasecontactSonoSiteas follows:

SonoSite Technical Support Phone (US or Canada):

Phone (Outside US and Canada):

Fax:

E-mail:

Web site:

Europe Service Center:

877-657-8118 425-951-1330 Or call your local representative. 425-951-6700 service@sonosite.com www.sonosite.com Click Support & Service.

+44-(0)1462-444-800 uk.service@sonosite.com Introduction ThisMTurboUltrasoundSystemUserGuide providesinformationonpreparingandusingthe MTurboultrasoundsystemandoncleaning anddisinfectingthesystemandtransducers.It alsoprovidesreferencesforcalculations,system specifications,andsafetyandacousticoutput information. Theuserguideisforareaderfamiliarwith ultrasoundtechniques.Itdoesnotprovide traininginsonographyorclinicalpractices. Beforeusingthesystem,youmusthave ultrasoundtraining. SeetheapplicableSonoSiteaccessoryuserguide forinformationonusingaccessoriesand peripherals.Seethemanufacturersinstructions forspecificinformationaboutperipherals. Conventions, symbols, and terms Theuserguidefollowstheseconventions:

AWARNINGdescribesprecautionsnecessary topreventinjuryorlossoflife. ACautiondescribesprecautionsnecessaryto protecttheproducts. Numberedstepsinproceduresmustbe performedinorder. Itemsinbulletedlistsdonotrequirea sequence. Singlestepproceduresbeginwith. Symbolsandtermsusedonthesystemand transducerareexplainedinChapter 1,Chapter 5, Chapter 6,andGlossary. vii viii Customer comments Chapter 1: Getting Started About the system TheMTurboultrasoundsystemisaportable, softwarecontrolleddeviceusingalldigital architecture.Thesystemhasmultiple configurationsandfeaturesetsusedtoacquire anddisplayhighresolution,realtime ultrasoundimages.Featuresavailableonyour systemdependonsystemconfiguration, transducer,andexamtype. Alicensekeyisrequiredtoactivatethesoftware. SeeSoftwarelicensingonpage 71.On occasion,asoftwareupgrademayberequired. SonoSiteprovidesaUSBdevicecontainingthe software.OneUSBdevicecanbeusedtoupgrade multiplesystems. 3 G e t t i n g S t a r t e d 1 2 3 4 Figure 2 System Back Connectors:

(1) DC input connector, (2) I/O connector, (3) Battery, and (4) ECG connector To use the ultrasound system 1 Attachatransducer. 2 Turnthesystemon.(Forpowerswitch location,seeSystemcontrolsonpage 5.) 3 PressthePATIENTkey,andcompletethe patientinformationform. 4 Pressanimagingmodekey:2D,M MODE, COLOR,orDOPPLER 1 2 Figure 1 System Front Features:

(1) Control panel, (2) Handle, (3) Display, (4) USB ports for storage, updates, importing, and exporting 4 Preparing the system Installing or removing the battery WARNING:

To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing. To avoid data loss and to conduct a safe system shutdown, always keep a battery in the system. Chapter 1: Getting Started 1 To install the battery 1 Disconnectthepowersupplyfromthe ultrasoundsystem. 2 Removethesystemfromtheminidock(if present)andturnitupsidedown. 3 Placethebatteryintothebattery compartment,ataslightangle.SeeFigure 3. 4 Slidethebatteryforwarduntilitlocksinto place. Locking levers 5 Pushdownonthetwolockingleverstosecure thebattery. To remove the battery 1 Disconnectthepowersupplyfromthe ultrasoundsystem. 2 Removethesystemfromtheminidock(if present)andturnitupsidedown. 3 Pullupthetwolockinglevers. 4 Slidethebatteryback. 5 Liftthebatteryfromthecompartment. Using AC power and charging the battery Thebatterychargeswhenthesystemis connectedtotheACpowersupply.Afully dischargedbatteryrechargesinlessthanfive hours. ThesystemcanrunonACpowerandchargethe batteryifACpowerisconnectedtothesystem directly,toaminidock,ortoadockingsystem. Thesystemcanrunonbatterypowerforupto twohours,dependingontheimagingmodeand thedisplaybrightness.Whenrunningonbattery power,thesystemmaynotrestartifthebatteryis low.Tocontinue,connectthesystemtoAC power. Figure 3 Install the Battery 2 Preparing the system WARNING:

The equipment shall be connected to a center-tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system. Caution:

Verify that the hospital supply voltage corresponds to the power supply voltage range. See Electrical on page 154. To operate the system using AC power 1 ConnecttheDCpowercablefromthepower supplytotheconnectoronthesystem.See Figure 2onpage 1. 2 ConnecttheACpowercordtothepower supplyandtoahospitalgradeelectrical outlet. Turning the system on or off Caution:

Do not use the system if an error message appears on the display. Note the error code and turn off the system. Call SonoSite or your local representative. To turn the system on or off

Pressthepowerswitch.(SeeSystem controlsonpage 5.) To wake up the system Toconservebatterylifewhilethesystemison, thesystemgoesintosleepmodeifthelidisclosed orifthesystemisuntouchedforapresettime.To adjustthetimeforsleepdelay,seeAudio, Batterysetuponpage 19.

Pressakey,touchthetouchpad,oropenthe lid. Connecting transducers WARNING:

Caution:

To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in a docking system or on a flat hard surface to allow air flow past the connector. To avoid damaging the transducer connector, do not allow foreign material in the connector. G e t t i n g S t a r t e d Figure 4 Connect the Transducer Chapter 1: Getting Started 3 To connect a transducer 1 Removethesystemfromtheminidock(if present),andturnitupsidedown. 2 Pullthetransducerlatchup,androtateit clockwise. WARNING:

3 Alignthetransducerconnectorwiththe connectoronthebottomofthesystem. 4 Insertthetransducerconnectorintothe systemconnector. 5 Turnthelatchcounterclockwise. 6 Pressthelatchdown,securingthetransducer connectortothesystem. To remove a transducer 1 Pullthetransducerlatchup,androtateit clockwise. 2 Pullthetransducerconnectorawayfromthe system. Inserting and removing USB storage devices Imagesandclipsaresavedtointernalstorageand areorganizedinasortablepatientlist.Youcan archivetheimagesandclipsfromtheultrasound systemtoaPCusingaUSBstoragedeviceor Ethernetconnection.Althoughtheimagesand clipscannotbeviewedfromaUSBstoragedevice ontheultrasoundsystem,youcanremovethe deviceandviewthemonyourPC. TherearetwoUSBportsonthesystem,andone ontheminidock.ForadditionalUSBports,you canconnectaUSBhubintoanyUSBport. Note: Thesystemdoesnotsupportpassword protectedUSBstoragedevices.Makesurethatthe USBstoragedeviceyouusedoesnothavepassword protectionenabled. To avoid damaging the USB storage device and losing patient data from it, observe the following:

Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break. If the USB icon does not appear in the system status area on-screen, the USB storage device may be defective or password-protected. Turn the system off and replace the device. Caution:

To insert a USB storage device

InserttheUSBstoragedeviceintoanyUSB portonthesystemorminidock.SeeFigure 1 onpage 1. TheUSBstoragedeviceisreadywhenthe USBiconappears. Toviewinformationaboutthedevice,see USBDevicessetuponpage 23. To remove a USB storage device RemovingtheUSBstoragedevicewhilethe systemisexportingtoitmaycausetheexported filestobecorruptedorincomplete. 1 WaitfivesecondsaftertheUSBanimation stops. 2 RemovetheUSBstoragedevicefromtheport. 4 Preparing the system System controls 1 2 3 4 5 6 7 14 15 16 17 18 19 20 G e t t i n g S t a r t e d 1 2 3 4 5 6 7 8 9 10 11 12 13 Power switch Turns system on and off. Alphanumeric keys Use to enter text and numbers. Annotation keys See Alphanumeric keyboard on page 9. ZOOM Magnifies the image 100%. DEPTH UP, DEPTH DOWN Decreases and increases imaging depth. AUTO GAIN Adjusts gain automatically. Gain Near Far Gain/

Cine Buffer Adjusts the gain applied to the near field of the image. Adjusts the gain applied to the far field of the image. In live imaging, adjusts the overall gain applied to the entire image. On a frozen image, moves the cine buffer. Chapter 1: Getting Started 5 8 9 10 11 12 13 14 15 16 17 18 AC power indicator A steady light indicates that AC power is connected. A flashing light indicates that the system is asleep. CALIPER CALCS Touchpad FREEZE SAVE Displays calipers on-screen for measuring. Turns the calculations menu on and off. Selects, adjusts, and moves items on-screen. Stops live imaging and displays a frozen image. Saves an image to internal storage. If configured, also saves calculations to the report. See Presets setup on page 22. CLIP Saves a clip to internal storage. Control keys Control on-screen options. Forms SETUP REPORT REVIEW PATIENT EXAM Displays the system settings. Accesses the patient report and EMED worksheets. Accesses the patient list, saved images, and archiving functions. Accesses patient information. Opens exam menu. A & B shortcut keys Keys that you can program to perform common tasks. SET SELECT Sets a trace measurement. Used with the touchpad to select items on-screen. Also switches between Color and Doppler options, calipers for measurement, pictograph-marker position and angle, frozen images in duplex and dual screens, and arrow position and orientation. SAVE CALC Saves calculations and their measurements to the patient report. 19 UPDATE Toggles between dual and duplex screens and imaging modes in M Mode and Doppler (for example, between D-line and Doppler spectral trace). 20 Imaging Modes M MODE DOPPLER COLOR 2D Turns M Mode on, toggles between M-line and M Mode trace. Turns Doppler on, toggles between D-line and Doppler trace. Turns CPD/Color on and off. Turns 2D on. 6 System controls Screen layout 1 2 3 4 5 6 7 8 9 10 11 G e t t i n g S t a r t e d Figure 1 Screen Layout 1 2 3 4 5 6 7 8 9 Mode Data Area Current imaging mode information (for example, Gen, Res, THI, and PW). Orientation Marker Provides indication for image orientation. In dual and duplex images, the orientation marker is green on the active screen. Text Pictograph Text entered using keyboard. Pictograph to indicate anatomy and transducer position. You can select anatomy and screen location. Calculations Menu Contains available measurements. Image Ultrasound image. Measurement and Calculations Data Area Current data on measurements and calculations. On-screen Options Options available in the current context. Patient Header Includes current patient name, ID number, institution, user, and date/time. 10 System Status Information on system status (for example, exam type, transducer, AC connected, battery charging, and USB). 11 Depth Marker Marks in .5 cm, 1 cm, and 5 cm increments depending on depth. Chapter 1: Getting Started 7 General interaction Touchpad and cursor Usethetouchpadtoadjustandmoveobjects onscreen.Thetouchpadcontrolscaliper position,CPDorColorboxpositionandsize,the cursor,andmore.Thearrowkeyscontrolmuch ofthesamefunctionalityasthetouchpad. Thecursorappearsinthesetuppages,thepatient informationform,andpatientreport.Youcontrol thecursorthroughthetouchpad.Forexample,in thepatientinformationform,placethecursor overthelastnamefieldandpresstheSELECT keytoactivatethatfield.Additionally,youcan usethecursortoselectcheckboxesanditemsin lists. On-screen options Theonscreenoptionsletyoumakeadjustments andselectsettings.Theoptionsavailabledepend oncontext. Eachoptioniscontrolledbythepairofkeys belowit.Dependingontheoption,thecontrol keysfunctioninoneoffourways:

Cycle Movesthroughalistofsettings continuously.Theuppercontrolkeycycles upward.Thelowercontrolkeycyclesdownward. Up-Down Movesthroughalistofsettings, stoppingatthetoporbottom.Theuppercontrol keymovesupward.Thelowercontrolkeymoves downward.Bydefault,abeepsoundswhenyou reacheitherendoftherange.(SeeAudio,Battery setuponpage 19.) On-Off Turnsafeatureonoroff.Youcanpress eithercontrolkey.Informs,youcaninsteadselect theoptionbyusingthetouchpadandthe SELECTkey. Action Performsanaction.Youcanpresseither controlkey.Oryoucaninsteadselecttheoption byusingthetouchpadandtheSELECTkey. Figure 5 On-screen options (2D imaging shown) 8 General interaction Annotation and text Alphanumeric keyboard 1 2 3 4 5 6 7 8 9 1 TAB Moves cursor among fields in the forms, and tabs between text position in dual screens. 8 9 DELETE Arrow Keys CAPS LOCK Sets the keyboard to capital letters. 2 3 4 5 6 SHIFT TEXT PICTO ARROW 7 SPACEBAR Allows entry of capitalized characters and international characters. Turns the keyboard on and off for text entry. Turns pictographs on and off. Displays an arrow graphic that can be moved and rotated within the image area. Turns the keyboard on for text entry. In text entry, adds a space. 10 BACKSPACE 11 ENTER 10 11 G e t t i n g S t a r t e d Removes all text from the screen during text entry and when not measuring. Move highlighted selection in calculations menu, move cursor one space when entering text, move caliper position, move cine buffer forward and backward, and move among pages in image review and reports. Removes the character left of the cursor in text-entry mode. Moves cursor among fields in forms and saves calculations to report. Chapter 1: Getting Started 9 Symbols Youcanentersymbolsandspecialcharactersin selectfieldsandforms.Thesymbolsandspecial charactersavailabledependoncontext. Patient information form: Last,First,Middle, PatientID,Accession,Indications,ProcedureID, User,ReadingDr.,ReferringDr.,andInstitution fields DICOM or SiteLink configuration page: Aliasand AETitlefields A & B Key, Footswitch setup page: Textfield Text mode (imaging): Annotationfield Figure 6 Symbols Dialog Box To enter symbols or special characters 1 Selectthefield,andthenselectSymbols. 2 Selectthedesiredsymbolorcharacter. Youcanalsopressthekeysonthekeyboard. 3 SelectOK. Preparing transducers WARNING:

Caution:

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. Some gels and sterilants can cause an allergic reaction on some individuals. To avoid damage to the transducer, use only gels recommended by SonoSite. Using gels other than the one recommended by SonoSite can damage the transducer and void the warranty. If you have questions about gel compatibility, contact SonoSite or your local representative. SonoSite recommends that you clean transducers after each use. See Cleaning and disinfecting transducers on page 74. Acousticcouplinggelmustbeusedduring exams.Althoughmostgelsprovidesuitable acousticcoupling,somegelsareincompatible withsometransducermaterials.SonoSite recommendsAquasonicgelandprovidesa samplewiththesystem. Forgeneraluse,applyaliberalamountofgel betweenthetransducerandthebody.For invasiveorsurgicaluse,applyatransducer sheath. 10 Preparing transducers G e t t i n g S t a r t e d WARNING:

To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure. To apply a transducer sheath SonoSiterecommendstheuseofmarketcleared, transducersheathsforintracavitaryorsurgical applications.Tolessentheriskofcontamination, applythesheathonlywhenyouarereadyto performtheprocedure. 1 Placegelinsidethesheath. 2 Insertthetransducerintothesheath. 3 Pullthesheathoverthetransducerandcable untilthesheathisfullyextended. 4 Securethesheathusingthebandssupplied withthesheath. 5 Checkforandeliminatebubblesbetweenthe faceofthetransducerandthesheath. Bubblesbetweenthefaceofthetransducer andthesheathmayaffecttheultrasound image. 6 Inspectthesheathtoensurethatthereareno holesortears. Training videos TheSonoSiteEducationKeytrainingvideos areanoptionalfeature. To display the list of videos 1 InserttheEducationKeyUSBdeviceintoa USBportonthesystem. 2 PresstheREVIEWkey. 3 Ifthereisanactiveexam,selectListonscreen. 4 SelecttheVideostab. 5 Ifthelistdoesnotappear,selectthecorrect USBdevice:

a SelectSelect USB. b IntheSelect USB device for media playback dialog box,selecttheEducation KeyUSBdevice(Trainingappearsunder Type),andthenselectSelect. Note: ImageGalleryisanunsupportedfeature. To view a video 1 Displaythelistofvideos. 2 Selectthevideo. 3 SelectViewonscreen. Thevideobeginsplaying. 4 Selectanyofthefollowing,asneeded:

Adjuststhevolume.Thehigherthe number,thelouderthesound.Zerois mute. BackRewindsthevideo10seconds. Pause Pausesthevideo. PlayResumesplayingofapausedvideo. ForwardAdvancesthevideo10seconds. To exit a video

Selectoneofthefollowing:

Listtoreturntothevideolist. Donetoreturnto2Dimaging. Intended uses Thissystemtransmitsultrasoundenergyinto variouspartsofthepatientsbodytoobtain ultrasoundimages,asfollows. Fortheintendedtransducerandimagingmodes foreachexamtype,seeImagingmodesand examsavailablebytransduceronpage 31. Chapter 1: Getting Started 11 multiplepregnancy,fetalhydrops,placental abnormalities,aswellasmaternalhypertension, diabetes,andlupus. WARNING:

To prevent injury or misdiagnosis, do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses. CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR). Pediatric and Neonatal Imaging Applications Youcanassessthepediatricandneonatal abdominal,pelvicandcardiacanatomy,pediatric hips,neonatalhead,andsurroundinganatomical structuresforthepresenceorabsenceof pathology. Superficial Imaging Applications Youcanassess thebreast,thyroid,testicle,lymphnodes, hernias,musculoskeletalstructures,softtissue structures,ophthalmicstructures,and surroundinganatomicalstructuresforthe presenceorabsenceofpathology.Youcanusethe systemforultrasoundguidanceinbiopsyand drainageprocedures,vascularlineplacement, peripheralnerveblocks,andspinalnerveblocks andtaps. Abdominal Imaging Applications Youcanassess theliver,kidneys,pancreas,spleen,gallbladder, bileducts,transplantedorgans,abdominal vessels,andsurroundinganatomicalstructures forthepresenceorabsenceofpathology transabdominally. Cardiac Imaging Applications Youcanassessthe heart,cardiacvalves,greatvessels,surrounding anatomicalstructures,overallcardiac performance,andheartsizeforthepresenceor absenceofpathology. Youcanobtainthepatientselectrocardiogram

(ECG).TheECGisusedfortimingofcardiac events. WARNING:

The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring. Gynecology and Infertility Imaging Applications Youcanassesstheuterus,ovaries,adnexa,and surroundinganatomicalstructuresforthe presenceorabsenceofpathology transabdominallyortransvaginally. Interventional Imaging Applications Youcanuse thesystemforultrasoundguidanceinbiopsyand drainageprocedures,vascularlineplacement, peripheralnerveblocks,spinalnerveblocksand taps,ovaharvesting,amniocentesisandother obstetricalprocedures,andprovideassistance duringabdominal,breast,andneurological surgery. Obstetrical Imaging Applications Youcanassess thefetalanatomy,viability,estimatedfetal weight,gestationalage,amnioticfluid,and surroundinganatomicalstructuresforthe presenceorabsenceofpathology transabdominallyortransvaginally.CPDand Colorimagingareintendedforhighrisk pregnantwomen.Highriskpregnancy indicationsinclude,butarenotlimitedto, 12 Intended uses WARNING:

To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected. Transcranial Imaging Applications Youcan assesstheanatomicalstructuresandvascular anatomyofthebrainforpresenceorabsenceof pathology.Youcanuseimagingtemporally, transoccipitally,ortransorbitally. WARNING:

To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected. Vascular Imaging Applications Youcanassessthe carotidarteries,deepveins,andarteriesinthe armsandlegs,superficialveinsinthearmsand legs,greatvesselsintheabdomen,andvarious smallvesselsfeedingorgansforthepresenceor absenceofpathology. G e t t i n g S t a r t e d Chapter 1: Getting Started 13 14 Intended uses Chapter 2: System Setup Thesystemsetuppagesletyoucustomizethe systemandsetpreferences. Displaying the setup pages To display a setup page 1 PresstheSETUPkey. 2 SelectthesetuppageunderSetup Pages. Toreturntoimagingfromasetuppage,select Doneonscreen. Restoring default settings To restore default settings for a setup page

Onthesetuppage,select Resetonscreen. To restore all default settings 1 Turnthesystemoff. 2 ConnectthesystemtoACpower.(SeeTo operatethesystemusingACpoweron page 3.) 3 Simultaneouslypress1andthepowerkey. Thesystembeepsseveraltimes. A & B Key, Footswitch setup OntheA&BKey,Footswitchsetuppage,youcan programtheshortcutkeysandfootswitchto performcommontasks.Selectfromthefollowing lists:

A Key, B Key Thefunctionoftheshortcutkeys.By default,theAshortcutkeyissettoPrintandthe BshortcutkeyissettoRecord.Theshortcutkeys arebelowthealphanumerickeypad. Footswitch (L),Footswitch (R) Thefunctionofthe leftandrightfootswitches:Save Clip,Record, Freeze,Save Image,orPrint.SeealsoToconnect thefootswitch. To connect the footswitch TheSonoSitefootswitchallowshandsfree operationwithacustomizabletwopedal footswitch.Thefootswitchisanoptionalfeature. WARNING:

To avoid contamination, do not use the footswitch in a sterile environment. The footswitch is not sterilized. 1 Connectthecables:

YadaptercabletotheECGconnectoron theminidockordockingsystem FootswitchcabletoYadaptercable 2 OntheA&BKey,Footswitchsetuppage, selectafunctionfortheleftandright footswitches. Administration setup OntheAdministrationsetuppage,youcan configurethesystemtorequireuserstologin andenterpasswords.Requiredloginhelps protectpatientdata.Youcanalsoaddanddelete users,changepasswords,importandexportuser accounts,andviewtheeventlog. S e t u p Chapter 2: System Setup 15 Security settings 2 IntheUser Loginlist,selectOn. WARNING:

Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act

(HIPAA) of 1996 and the European Union Data Protection Directive

(95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information. Securitysettingsonthesystemallowyoutomeet theapplicablesecurityrequirementslistedinthe HIPAAstandard.Usersareultimately responsibleforensuringthesecurityand protectionofallelectronicprotectedhealth informationcollected,stored,reviewed,and transmittedonthesystem. To log in as Administrator 1 OntheAdministrationsetuppage,type AdministratorintheNamebox. 2 Typetheadministratorpasswordinthe Passwordbox. Ifyoudonthavetheadministratorpassword, contactSonoSite.(SeeSonoSiteTechnical Supportonpage vii.) 3 SelectLogin. To log out as Administrator

Turnofforrestartthesystem. To require user login YoucansetthesystemtodisplaytheUserLogin screenatstartup. 1 LoginasAdministrator. Onrequiresausernameandpasswordat startup. Offallowsaccesstothesystemwithouta usernameandpassword. To change the administrator password or let users change passwords 1 LoginasAdministrator. 2 UnderUser List,selectAdministrator. 3 Doanyofthefollowing:

Changetheadministratorpassword:

UnderUser Information,typethenew passwordinthePasswordboxand Confirmbox.(SeeChoosingasecure passwordonpage 18.) Letuserschangetheirpasswords:Select thePassword changescheckbox. 4 SelectSave. User setup To add a new user 1 LoginasAdministrator. 2 SelectNew. 3 UnderUser Information,fillintheName, Password,andConfirmboxes.(SeeChoosing asecurepasswordonpage 18.) 4 (Optional)IntheUser box,typetheusers initialstodisplaytheminthepatientheader andtheUserfieldinthepatientinformation form. 5 (Optional)SelecttheAdministration Access checkboxtoallowaccesstoalladministration privileges. 6 SelectSave. To modify user information 1 LoginasAdministrator. 16 Administration setup 2 UnderUser List,selecttheuser. 3 UnderUser Information,makechangesas desired. 4 SelectSave. Anychangetotheusernamereplacesthe previousname. To delete a user 1 LoginasAdministrator. 2 UnderUser List,selecttheuser. 3 SelectDelete. 4 SelectYes. To change a user password 1 LoginasAdministrator. 2 IntheUser List,selecttheuser. 3 TypethenewpasswordinthePasswordbox andConfirmbox. 4 SelectSave. Exporting or importing user accounts Theexportandimportcommandsletyou configuremultiplesystemsandbackupuser accountinformation. To export user accounts 1 InsertaUSBstoragedevice. 2 LoginasAdministrator. 3 SelectExportonscreen.AlistofUSBdevices appears. 4 SelecttheUSBstoragedevice,andselect Export. Allusernamesandpasswordsarecopiedto theUSBstoragedevice. To import user accounts 1 InserttheUSBstoragedevicethatcontainsthe accounts. 2 LoginasAdministrator. 3 SelectImportonscreen. 4 SelecttheUSBstoragedevice,andselect Import. 5 Restartthesystem. Allusernamesandpasswordsonthesystem arereplacedwiththeimporteddata. Exporting and clearing the Event log TheEventlogcollectserrorsandeventsandcan beexportedtoaUSBstoragedeviceandreadon aPC. To display the Event log 1 LoginasAdministrator. 2 SelectLogonscreen. TheEventlogappears. Toreturntothepreviousscreen,selectBack. To export the Event log TheEventlogandtheDICOMnetworkloghave thesamefilename(log.txt).Exportingeitherone toaUSBstoragedeviceoverwritesanyexisting log.txtfile. 1 InsertaUSBstoragedevice. 2 SelectLogandthenselectExport onscreen. AlistofUSBdevicesappears. 3 SelecttheUSBstoragedevice,andselect Export. TheEventlogisatextfilethatyoucanopenina texteditingapplication(forexample,Microsoft WordorNotepad). To clear the Event log 1 DisplaytheEventlog. 2 SelectClearonscreen. 3 SelectYes. Chapter 2: System Setup 17 S e t u p Logging in as user Ifuserloginisrequired,theUserLoginscreen appearswhenyouturnonthesystem.(SeeTo requireuserloginonpage 16.) To log in as user 1 Turnonthesystem. 2 IntheUser Loginscreen,typeyournameand password,andselectOK. To log in as guest Guestscanscanbutcantaccesssystemsetupand patientinformation. 1 Turnonthesystem. 2 IntheUser Loginscreen,selectGuest. To change your password 1 Turnonthesystem. 2 IntheUser Loginscreen,selectPassword. 3 Typeyouroldandnewpasswords,confirm thenewpassword,andthenselectOK. Choosing a secure password Toensuresecurity,chooseapasswordthat containsuppercasecharacters(AZ),lowercase characters(az),andnumbers(09).Passwords arecasesensitive. Annotations setup OntheAnnotationssetuppage,youcan customizepredefinedlabelsandsetthe preferenceformanagingtextwhenunfreezing images. Forinstructionstoannotateimages,see Annotatingimagesonpage 32. To predefine a label group Youcanspecifywhichlabelsareavailableforan examtypewhenannotatinganimage.(SeeTo placetextonanimageonpage 32.) 1 IntheExamlistontheAnnotationssetup page,selecttheexamtypewhoselabelsyou wanttospecify. 2 ForGroup,select A, B, or Cforthelabelgroup youwantassociatedwiththatexam. Thepresetlabelsappearfortheselectedgroup. 3 Doanyofthefollowing:

Addacustomlabeltothegroup:Typethe labelintheTextbox,andselectAdd. Renamealabel:Selectthelabel,typethe newnameintheTextbox,andselect Rename. Movealabelwithinthegroup:Selectthe label,andthenselecttheonscreenupor downarrow. Deletealabelfromagroup:Selectthe label,andselectDelete. Youcanusesymbolsinlabels.SeeSymbols onpage 10. To specify text retention when unfreezing Youcanspecifywhichtexttokeepwhenyou unfreezeanimageorchangetheimaginglayout.

IntheUnfreezelistontheAnnotationssetup page,selectKeep All Text,Keep Home Text,or Clear All Text. ThedefaultsettingisKeep All Text.For informationonsettingthehomeposition,see Toresetthehomepositiononpage 33. To export predefined label groups 1 InsertaUSBstoragedevice. 2 OntheAnnotationssetuppage,selectExport. AlistofUSBdevicesappears. 3 SelecttheUSBstoragedevice,andselect Export. Acopyofallpredefinedlabelgroupsforall examssavestotheUSBstoragedevice. 18 Annotations setup To import predefined label groups 1 InserttheUSBstoragedevicethatcontainsthe labelgroups. 2 OntheAnnotationssetuppage,selectImport onscreen. 3 SelecttheUSBstoragedevice,andthenselect Import. 4 SelectDoneinthedialogboxthatappears. Allpredefinedlabelgroupsforallexamsare replacedwiththosefromtheUSBstorage device. Audio, Battery setup OntheAudio,Batterysetuppage,youcanselect optionsinthefollowinglists:

Key clickSelectOnorOffforkeystoclickwhen pressed. Beep alert SelectOnorOffforthesystemtobeep whensaving,warning,starting,orshutting down. Sleep delaySelectOff,or5or10minutesto specifytheperiodofinactivitybeforethesystem goesintosleepmode. Power delaySelectOff,or15or30minutesto specifytheperiodofinactivitybeforethesystem automaticallyturnsoff. Cardiac Calculations setup OntheCardiacCalculationssetuppage,youcan specifymeasurementnamesthatappearinthe TissueDopplerImaging(TDI)calculationsmenu andonthereportpage. SeealsoCardiaccalculationsonpage 50. To specify cardiac measurement names

UnderTDI WallsontheCardiacCalculations setuppage,selectanameforeachwall. Connectivity setup OntheConnectivitysetuppage,youspecify optionsforusingnonUSBdevicesandforalerts wheninternalstorageisfull.Youalsoimport wirelesscertificatesandspecifysettings

(includingTransferModeandLocation)for SiteLinkandDICOM,whichareoptional features.RefertotheSiteLinkandDICOM documentation. To configure the system for a printer 1 Setuptheprinterhardware.(Seeinstructions includedwiththeprinterordockingsystem.) 2 InthePrinterlistontheConnectivitysetup page,selecttheprinter. To configure the system for a DVD recorder, PC, or serial bar code scanner 1 OntheConnectivitysetuppage,dothe following:

(DVDrecorder)IntheVideo Modelist, selectthevideostandard:NTSCorPAL. IntheSerial Portlist,selecttheperipheral. Computer (PC) allowspatientreportdata tobesentasASCIItextfromthesystemto aPC.ThePCmusthavethirdparty softwaretoacquire,view,orformatthe dataintoareport.Checkthecompatibility ofyoursoftwarewithSonoSiteTechnical Support.(SeealsoTosendapatient reporttoaPConpage 69.) Note: Becausetheseperipheralsusethesame RS232connectorontheminidock,youcan connectonlyoneofthematatime. 2 Restartthesystem. 3 Attachaserialcable(RS232)fromtheserial portontheminidockordockingsystemto theperipheral. S e t u p Chapter 2: System Setup 19 To receive storage alerts

OntheConnectivitysetuppage,select Internal Storage Capacity Alert. Thesystemdisplaysamessageifinternal storageisnearcapacitywhenyouendan exam.Thesystemthendeletesarchived patientexamsifspecifiedinDICOM. Date and Time setup WARNING:

To obtain accurate obstetrics calculations, an accurate date and time are critical. Verify that the date and time are accurate before each use of the system. The system does not automatically adjust for daylight saving time changes. To set the date and time

OntheDateandTimesetuppage,dothe following:

IntheDate box,typethecurrentdate. IntheTime box,typethecurrenttimein 24 hourformat(hoursandminutes). Display Information setup OntheDisplayInformationsetuppage,youcan specifywhichdetailsappearonscreenduring imaging.Youcanselectsettingsinthefollowing sections:

Patient HeaderInformationthatappearsinthe patientheader. Mode DataImaginginformation. System StatusSystemstatusinformation. IMT Calculations setup OntheIMTCalculationssetuppage,youcan customizetheIMTcalculationsmenu.Youcan specifyuptoeightmeasurementnamesforboth rightsideandleftsidecalculations.The measurementnamesalsoappearinthepatient report. SeealsoIMTcalculationsonpage 59. To customize the IMT calculations menu

OntheIMTCalculationssetuppage,dothe following:

UnderIMT Calculations,select measurementnamesfromthelists,or selectNone. Theselectednamesappearinthe calculationsmenuandinthepatient report. Typethedesiredwidthinthe Region width (mm)box. Network Status setup TheNetworkStatussetuppagedisplays informationonsystemIPaddress,Location, EthernetMACaddress,andthewireless connectionifany. OB Calculations setup OntheOBCalculationssetuppage,youselect authorsforOBcalculationtables.Youcanalso importorexportadditionalOBcalculationtables. SeealsoOBcalculationsonpage 61. 20 Date and Time setup S e t u p To import OB calculationtables Tablesthatyouimportareaddedtothosealready onthesystem. 1 InserttheUSBstoragedevicethatcontainsthe tables. 2 OntheOBCalculationssetuppage,select Importonscreen. 3 SelecttheUSBstoragedevice,andthenselect Import. 4 SelectOKinthedialogboxthatappears. Thesystemrestarts. OB Custom Measurements setup OntheOBCustomMeasurementssetuppage, youcandefinemeasurementsthatappearinthe OBcalculationsmenuandOBreport.OBCustom Measurementsisanoptionalfeature. SeealsoOBcalculationsonpage 61. To set up OB custom measurements Youcansaveuptofivecustommeasurements thatappearintheOBcalculationsmenuandOB report. 1 OntheOBCustomMeasurementssetuppage, selectNew. 2 IntheNamebox,typeauniquename. 3 IntheTypelist,selectthedesired measurementtype. 4 SelectSave. To delete an OB custom measurement IfyoudeleteanOBcustommeasurementduring anexam,theexamends. 1 OntheOBCustomMeasurementssetuppage, highlightthemeasurementintheCustom Measurementslist. 2 SelectDelete Last. Chapter 2: System Setup 21 Figure 1 OB Calculations Setup Page To specify gestational age and growth analysis 1 OntheOBCalculationssetuppage,selectthe desiredOBauthors(orselectNone)inthe measurementlistsunderGestational Ageand Growth Analysis. Selectinganauthorplacestheassociated measurementonthecalculationsmenu. 2 (Optional)SelectMoretodisplaythelistof userdefinedcustommeasurementsandto associateacustomtableforthecustom measurement. Thisoptionisavailableonlywhena userdefinedcustomtablehasbeencreated forthecustommeasurement. To export OB calculation tables 1 InsertaUSBstoragedevice. 2 OntheOBCalculationssetuppage,select Export.AlistofUSBdevicesappears. 3 SelecttheUSBstoragedevice,andselect Export. Alluserdefinedtablesandmeasurementsare copiedtotheUSBstoragedevice. 3 SelectYes. Theexamends,andanytablesandreport dataassociatedwiththemeasurementare removedfromthesystem. OB Custom Tables setup OntheOBCustomTablessetuppages,youcan customizegrowthtablesthatappearinthe calculationsmenuandpatientreport. Gestational Age Table Measurements Thesystem providesgestationalagemeasurementsby selectedauthorsforCRL,GS,BPD,OFD,HC,AC, FL,APTD,TTD,FTA,and5 additionalcustom measurementlabels. Growth Analysis Table MeasurementsThe systemprovidesgrowthgraphsorcurvesfor BPD,HC,AC,FL,EFW,andHC/AC. WARNING:

Prior to use, verify that custom table data entries are correct. The system does not confirm the accuracy of the custom table data entered by the user. To view OB tables 1 OntheOBCalculationsorOBCustom Measurementssetuppage,selectTables onscreen. 2 Selectthedesiredtableand measurement/author. To create a new OB custom table YoucancreatetwocustomtablesforeachOB measurement. 1 OntheOBCalculationsorOBCustom Measurementssetuppage,selectTables onscreen. 2 Selectthedesiredtable(GestationalAgeor Growth Analysis). 3 IntheMeasurementlist,selectthe measurementforthecustomtable. 4 SelectNewonscreen. 5 IntheAuthorbox,typeauniquename. 6 Enterthedata. 7 SelectSaveonscreen. Todisplaythemeasurementforthecustomtable inthecalculationsmenu,seeTospecify gestationalageandgrowthanalysisonpage 21. To edit or delete an OB custom table 1 OntheOBCalculationsorOBCustom Measurementssetuppage,selectTables onscreen. 2 SelecttheOBcustomtable. 3 Selectoneofthefollowingonscreen:

EditEnterdata,andthenselectSave onscreen. Deletetoremovethecustomtable.Select Yes. Presets setup ThePresetssetuppagehassettingsforgeneral preferences.Youcanselectfromthefollowing lists:

Doppler ScaleSelectcm/sorkHz. Duplex ThelayoutfordisplayingMModetrace andDopplerspectraltrace:1/3 2D, 2/3 Trace;1/2 2D, 1/2 Trace;orFull 2D, Full Trace. Live TraceSelectPeakorMean. Thermal Index YoucanselectTIS,TIB,orTIC.The defaultsettingisbasedonexamtype:OBisTIB, TCDisTIC,andallothersareTIS. Save KeyBehavioroftheSAVEkey.Image Only savestheimagetointernalstorage.Image/Calcs savestheimagetointernalstorageandsavesthe currentcalculationtothepatientreport. Dynamic RangeSettingsinclude-3,-2,-1,0,+1,

+2,or+3.Negativenumbersshowhigher 22 OB Custom Tables setup contrastimages,andpositivenumbersshow lowercontrastimages. UnitsUnitsforpatientheightandweightin cardiacexams:in/ft/lbsorcm/m/kg. LanguageThesystemlanguage.Changingthe languagerequiresrestartingthesystem. Color SchemeThebackgroundcolorofthe display. Auto save Pat. FormAutomaticallysavesthe patientinformationformasanimageinthe patientsfile. System Information setup TheSystemInformationsetuppagedisplays systemhardwareandsoftwareversions,and licenseinformation. SeealsoToenteralicensekeyonpage 72. USB Devices setup OntheUSBDevicessetuppage,youcanview informationaboutconnectedUSBdevices, includingspaceavailability.Youcanalsospecify afileformatforimagesandclipsinpatientexams thatyouexporttoaUSBstoragedevice.(SeeTo exportpatientexamstoaUSBstoragedeviceon page 38.) To specify a file format for exported images 1 OntheUSBDevicessetuppage,selectExport. 2 UnderUSB Export,selectanexporttype:

SiteLinkorganizesfilesinaSiteLinkstyle folderstructure.ClipsexportinH.264 videosavedasMP4files.Toviewthem, SonoSiterecommendsQuickTime7.0or later. DICOMcreatesfilesreadablebyaDICOM reader.DICOMisanoptionalfeature. 3 Selectanimageformatforyourexporttype. ForJPEGimageformat,alsoselectaJPEG compression.(SeealsoLimitationsofJPEG format.) Ahighcompressionhasasmallerfilesizebut lessdetail. ForSiteLinkexporttype,theimageformat affectsonlystillimages.ForDICOMexport type,theimageformataffectsbothstill imagesandclips. 4 ForSiteLinkexporttype,selectasortorder underSort By. Toreturntothepreviousscreen,selectDevices. Limitations of JPEG format WhentransferringorexportingimagesinJPEG format,thesystemuseslossycompression.Lossy compressionmaycreateimagesthathaveless absolutedetailthanBMPformatandthatdont renderidenticallytotheoriginalimages. Insomecircumstances,lossycompressedimages maybeinappropriateforclinicaluse.For example,ifyouuseimagesinSonoCalcIMT software,youshouldtransferorexportthem usingBMPformat.SonoCalcIMTsoftwareusesa sophisticatedalgorithmtomeasureimages,and lossycompressionmaycauseerrors. Formoreinformationonusinglossycompressed images,consulttheindustryliterature,including thefollowingreferences:

PhysicsinMedicineandBiology,Quality AssessmentofDSA,UltrasoundandCT DigitalImagesCompressedwiththeJPEG Protocol,DOkkalidesetal1994PhysMed Biol3914071421doi:

10.1088/00319155/39/9/008 www.iop.org/EJ/abstract/00319155/39/9/008 CanadianAssociationofRadiologists,CAR StandardsforIrreversibleCompressionin DigitalDiagnosticImagingwithin Radiology,Approved:June2008. www.car.ca/Files/%5CLossy_Compression. pdf Chapter 2: System Setup 23 S e t u p 24 USB Devices setup Chapter 3: Imaging Imaging modes Thesystemhasahighperformancedisplayand advancedimageoptimizationtechnologythat significantlysimplifiesusercontrols.Imaging modesavailabledependonthetransducerand examtype.SeeImagingmodesandexams availablebytransduceronpage 31. 2D imaging 2Disthesystemsdefaultimagingmode.The systemdisplaysechoesintwodimensionsby assigningabrightnesslevelbasedontheecho signalamplitude.Toachievethebestpossible imagequality,properlyadjustthedisplay brightness,gain,depthsettings,viewingangle, andexamtype.Also,selectanoptimization settingthatbestmatchesyourneeds. To display the 2D image 1 Doanyofthefollowing:

Turnonthesystem. Pressthe2Dkey. 2 Setoptionsasdesired.See2Doptions. Dual Dynamic Range 2D options In2Dimaging,youcanselectthefollowing onscreenoptions. Optimize Settings are as follows:

Res provides the best possible resolution. Gen provides a balance between resolution and penetration. Pen provides the best possible penetration. Some of the parameters optimized to provide the best image include focal zones, aperture size, frequency

(center and bandwidth), and waveform. They cannot be adjusted by the user. Adjusts the grayscale range: -3, -2,

-1, 0, +1, +2, +3. The positive range increases the number of grays displayed, and the negative range decreases the number of grays displayed. Displays side-by-side 2D images. Select Dual, and then press the UPDATE key to display the second screen and to toggle between the screens. With both images frozen, press the UPDATE key to toggle between the images. To return to full-screen 2D imaging, select Dual or press the 2D key. I m a g n g i Chapter 3: Imaging 25 LVO On, LVO Off LVO On turns on Left Ventricular Opacification. LVO Off turns off this option. Use LVO for cardiac exams in 2D imaging mode when using an imaging contrast agent. LVO lowers the mechanical index (MI) of the system to enhance visualization of the contrast agent and endocardial border. This option depends on transducer and exam type. Orientation Select from four image orientations:

U/R (Up/Right), U/L (Up/Left), D/L

(Down/Left), D/R (Down/Right). Brightness Adjusts the display brightness. Biopsy Guide Sector Settings range from 1 to 10. The display brightness affects battery life. To conserve battery life, adjust brightness to a lower setting. Turns biopsy guidelines on and off. This feature depends on transducer type. See the SonoSite Biopsy user guide. Biopsy is not available when the ECG cable is connected. Turns the guideline on and off. This feature depends on transducer and exam type. See the user guide for L25x transducer and needle guide.

(Cardiac exam) Specifies the sector width. SonoMB On is available only for Sector Full. SonoMB

(MB) ECG Clips THI Page x/x MB On and MB Off turn SonoMB multi-beam imaging technology on and off. When SonoMB is on, MB appears in the upper left-hand screen. SonoMB depends on transducer and exam type. Displays the ECG trace. See ECG Monitoring on page 38. This feature is optional and requires a SonoSite ECG cable. Displays the clips options. See To capture and save a clip on page 35. This feature is optional. Turns Tissue Harmonic Imaging on and off. When on, THI appears in the upper left-hand screen. This feature is optional and depends on transducer and exam type. Indicates which page of options is displayed. Select to display the next page. M Mode imaging Motionmode(M Mode)isanextensionof2D.It providesatraceofthe2Dimagedisplayedover time.Asinglebeamofultrasoundistransmitted, andreflectedsignalsaredisplayedasdotsof varyingintensities,whichcreatelinesacrossthe screen. To display the M-line 1 PresstheM MODEkey. Note: IftheMlinedoesnotappear,makesurethat theimageisntfrozen. 2 UsethetouchpadtopositiontheMlinewhere desired. 26 Imaging modes 3 Setoptionsasdesired. 2 SelectCPDorColor. Manyoptimizationanddepthoptions availablein2Dimagingarealsoavailablein M Modeimaging.See2Doptionson page 25. To display the M Mode trace 1 DisplaytheMline. 2 Adjustthedepthifnecessary.(SeeToadjust depthonpage 30.) 3 PresstheM MODEkey. Thetimescaleabovethetracehassmallmarks at200msintervalsandlargemarksat onesecondintervals. 4 Doanyofthefollowingasneeded:

Selectthesweepspeed Fast).

(Slow, Med,or PresstheUPDATEkeytotogglebetween theMlineandMModetrace. Ifusingaduplexlayout,presstheM MODE keytotogglebetweenthefullscreen Mlineandtheduplexlayout. Tosetaduplexlayout,seePresetssetup onpage 22. CPD and color Doppler imaging ColorpowerDoppler(CPD)andcolorDoppler

(Color)areoptionalfeatures. CPDisusedtovisualizethepresenceof detectablebloodflow.Colorisusedtovisualize thepresence,velocity,anddirectionofbloodflow inawiderangeofflowstates. To display the CPD or Color image 1 PresstheCOLORkey. AROIboxappearsinthecenterofthe2D image. Thecurrentselectionalsoappearsinthe upperlefthandscreen. TheColorindicatorbarontheupperlefthand screendisplaysvelocityincm/sinColor imagingmodeonly. 3 Usingthetouchpad,positionorresizetheROI boxasneeded.PresstheSELECTkeytotoggle betweenpositionandsize. WhileyoupositionorresizetheROIbox,a greenoutlineshowsthechange.TheROIbox indicatoronthelefthandscreenshowswhich touchpadfunctionisactive. 4 Setoptionsasdesired.SeeCPDandColor options. CPD and Color options InCPDorColorimaging,youcansetthe followingonscreenoptions. Color, CPD Color Suppress Flow Sensitivity Toggle between CPD and Color. The current selection appears in the upper left-hand screen. Shows or hides color information. You can select Show or Hide while in live or frozen imaging. The setting shown on-screen is the current selection. The current setting appears on-screen. Low optimizes the system for low flow states. Med optimizes the system for medium flow states. High optimizes the system for high flow states. I m a g n g i Chapter 3: Imaging 27 PRF Scale Wall Filter Steering Select the desired pulse repetition frequency (PRF) setting by pressing the control keys. There is a wide range of PRF settings for each Flow Sensitivity setting (Low, Med, and High). Available on select transducers. Settings include Low, Med, and High. Available on select transducers. Select the steering angle setting of the color ROI box (-15, 0, or +15). If adding PW Doppler, see PW Doppler options on page 29. Available on select transducers. Variance Turns variance on and off. Available only for cardiac exam. Invert Sector Switches the displayed direction of flow. Available in Color imaging.

(Cardiac exam) Specifies the sector width. Page x/x Indicates which page of options is displayed. Select to display the next page. PW and CW Doppler imaging Pulsedwave(PW)Dopplerandcontinuouswave

(CW)Dopplerimagingmodesareoptional features. PWDopplerisaDopplerrecordingofbloodflow velocitiesinarangespecificareaalongthelength ofthebeam.CWDopplerisaDopplerrecording ofbloodflowvelocitiesalongthelengthofthe beam. YoucanusePW/CWDopplerandCPD/Color simultaneously.IfCPD/Colorimagingison,the colorROIboxistiedtotheDline.TheSELECTkey cyclesamongcolorROIboxposition,colorROI boxsize,theDline,and(inPWDoppler)angle correction.Theactiveselectionisgreen.Also,the indicatoronthelefthandscreenshowswhich touchpadfunctionisactive. To display the D-line ThedefaultDopplerimagingmodeisPW Doppler.Incardiacexams,youcanselecttheCW Doppleronscreenoption. 1 PresstheDOPPLERkey. Note: IftheDlinedoesnotappear,makesure thatthesystemisinliveimaging. 2 Doanyofthefollowingasneeded:

Setoptions.SeePWDoppleroptionson page 29. Usingthetouchpad,positiontheDline wheredesired.

(PWDoppler)Tocorrecttheangle manually,presstheSELECTkeyandthen usethetouchpadtoadjusttheanglein2 incrementsfrom74to+74.Pressthe SELECTkeyagaintosetthedesiredangle. TheSELECTkeytogglesbetweentheDline andanglecorrection. To display the spectral trace 1 DisplaytheDline. 2 PresstheDOPPLERkey. Thetimescaleabovethetracehassmallmarks at200msintervalsandlargemarksat onesecondintervals. 3 Doanyofthefollowingasneeded:

Setoptions.SeeSpectraltraceoptions onpage 29. PresstheUPDATEkeytotogglebetween theDlineandspectraltrace. 28 Imaging modes Ifusingaduplexlayout,pressthe DOPPLERkeytotogglebetweenthe fullscreenDlineandtheduplexlayout. Tosetaduplexlayout,seePresetssetup onpage 22. PW Doppler options InPWDopplerimaging,youcansetthe followingonscreenoptions. PW, CW

(Cardiac exam only) Toggle between PW Doppler and CW Doppler. The current selection appears in the upper left-hand screen. Angle Correction Corrects the angle to 0, +60, or

-60. Gate Size TDI On, TDI Off Steering Settings depend on transducer and exam type. In TCD or Orb exams, use the touchpad to specify the Doppler gate depth (the depth of the center of the gate in the Doppler image). The Doppler gate depth indicator is on the lower right-hand screen. Select TDI On to turn on tissue Doppler imaging. When on, TDI appears in the upper left-hand screen. The default is TDI off. Available only in cardiac exams. Select the desired steering angle setting. The PW Doppler angle correction automatically changes to the optimum setting.

-15 has an angle correction of

-60. 0 has an angle correction of 0.

+15 has an angle correction of

+60. You can manually correct the angle after selecting a steering angle setting. (See To display the D-line on page 28.) Available on select transducers. Indicates which page of options is displayed. Select to display the next page. Page x/x Spectral trace options Inspectraltraceimaging,youcansetthe followingonscreenoptions. Scale Line Invert Select the desired scale (pulse repetition frequency [PRF]) setting.

(To change the Doppler scale to cm/s or kHz, see Presets setup on page 22.) Sets the baseline position.

(On a frozen trace, the baseline can be adjusted if Live Trace is off.) Vertically flips the spectral trace.

(On a frozen trace, Invert is available if Live Trace is off.) Volume Increases or decreases Doppler speaker volume (0-10). Wall Filter Settings include Low, Med, High. Sweep Speed Settings include Slow, Med, Fast. I m a g n g i Chapter 3: Imaging 29 Live Trace Page x/x Displays a live trace of the peak or mean. (See Presets setup on page 22 to specify peak or mean.) Indicates which page of options is displayed. Select to display the next page. Adjusting depth and gain To adjust depth Youcanadjustthedepthinallimagingmodes butthetracemodes.Theverticaldepthscaleis markedin0.5 cm,1 cm,and5 cmincrements, dependingonthedepth.

Pressthefollowingkeys:

UPDEPTHkeytodecreasethedisplayed depth. DOWNDEPTHkeytoincreasethedisplayed depth. Asyouadjustthedepth,themaximumdepth numberchangesinthelowerrightscreen. To adjust gain automatically

PresstheAUTO GAINkey.Thegainadjusts eachtimeyoupressthiskey. To adjust gain manually

Turnagainknob:

NEAR adjuststhegainappliedtothe nearfieldofthe2Dimage. FAR adjuststhegainappliedtothefar fieldofthe2Dimage. GAIN adjuststheoverallgainapplied totheentireimage.InCPDorColor imaging,theGAINknobaffectsthecolor gainappliedtotheregionofinterest(ROI) box.InPWandCWDopplerimaging,the theGAINknobaffectsDopplergain. Nearandfarcorrespondtothetimegain compensation(TGC)controlsonother ultrasoundsystems. Freezing, viewing frames, and zooming To freeze or unfreeze an image

PresstheFREEZEkey. Onafrozenimage,thecineiconandframe numberappearinthesystemstatusarea. To move forward or backward in the cine buffer

Freezetheimage,anddooneofthefollowing:

Turnthe Usethetouchpad.Rightmovesforward, knob. andleftmovesbackward. PresstheLEFTARROWandRIGHTARROW keys. Theframenumberchangesasyoumove forwardorbackward.Thetotalnumberof framesinthebufferappearsonscreeninthe systemstatusarea. To zoom in on an image Youcanzoomin2DandColorimaging.Youcan freezeorunfreezetheimageorchangethe imagingmodeatanytimewhilezooming. 1 PresstheZOOMkey.AROIboxappears. 2 Usingthetouchpad,positiontheROIboxas desired. 3 PresstheZOOMkeyagain. TheimageintheROIboxismagnifiedby 100%. 4 (Optional)Iftheimageisfrozen,usethe touchpadorarrowkeystopantheimageup, 30 Adjusting depth and gain down,left,andright.(Youcannotpanin Dual.) Imaging modes and exams available by transducer Toexitzoom,presstheZOOMkeyagain. Imaging modes and exams available by transducer WARNING:

To prevent misdiagnosis or harm to the patient, understand your systems capabilities prior to use. The diagnostic capability differs for each transducer, exam type, and imaging mode. In addition, transducers have been developed to specific criteria depending on their physical application. These criteria include biocompatibility requirements. To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic

(Oph) when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected. Thetransduceryouusedetermineswhichexam typesareavailable.Inaddition,theexamtype youselectdetermineswhichimagingmodesare available. To change the exam type

Dooneofthefollowing:

PresstheEXAMkey,andselectfromthe menu. Onthepatientinformationform,select fromtheTypelistunderExam.(See Patientinformationformonpage 33.) Imaging Mode 2 D 2 e d o M M 3 D P C 3 r o o C l 4 r e l p p o D W P r e l p p o D W C X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X r e c u d s n a r T C11x C60x D2x HFL38x ICTx 1 e p y T m a x E Abd Neo Nrv Vas OB Gyn Abd Nrv Crd Bre SmP Vas Msk IMT Nrv Ven Gyn OB I m a g n g i Chapter 3: Imaging 31 Imaging Mode Imaging Mode r e c u d s n a r T L25x L38x P10x P21x SLAx 1 e p y T m a x E Msk Vas Nrv Oph Sup Ven Bre SmP Vas IMT Nrv Ven Abd Crd Neo Abd OB Crd TCD Orb Msk Nrv Sup 2 D 2 e d o M M 3 D P C 3 r o o C l 4 r e l p p o D W P r e l p p o D W C X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X r e c u d s n a r T TEEx 1 e p y T m a x E Vas Ven Crd 2 D 2 e d o M M 3 D P C 3 r o o C l X X X X X X X X 4 r e l p p o D W P X X X r e l p p o D W C X 1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast, Crd = Cardiac, Gyn = Gynecology, IMT =

Intima Media Thickness, Msk = Muscle, Neo = Neonatal, Nrv = Nerve, OB = Obstetrical, Oph = Ophthalmic, Orb =

Orbital, SmP = Small Parts, Sup = Superficial, TCD =

Transcranial Doppler, Vas = Vascular, Ven = Venous. 2. The optimization settings for 2D are Res, Gen, and Pen. 3. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a range of PRF settings for Color depending on the setting selected. 4. For the cardiac exam type, PW TDI is also available. See PW Doppler options on page 29. Annotating images Youcanannotateliveimagesaswellasfrozen images.(Youcannotannotateasavedimage.) Youcanplacetext(includingpredefinedlabels), anarrow,orapictograph.Tosetpreferencesfor annotations,seeAnnotationssetuponpage 18. To place text on an image Youcanplacetextinthefollowingimaging layouts:fullscreen2D,fullscreentrace,dual,or duplex.Youcanplacetextmanuallyoradda predefinedlabel. 1 PresstheTEXTkey.Agreencursorappears. 2 Movethecursorwheredesired:

Usethetouchpadorarrowkeys. SelectHometomovethecursortothe homeposition. 32 Annotating images Thedefaulthomepositiondependsonthe imagingscreenlayout.Youcanresetthe homeposition.SeeToresetthehome positiononpage 33. 3 Usingthekeyboard,typetext. Thearrowkeysmovethecursorleft,right, up,anddown. TheDELETEkeydeletesalltext. Wordoptionremovesaword. The SelectSymbolstoenterspecialcharacters. SeeSymbolsonpage 10. 4 (Optional)Toaddapredefinedlabel,select Label,andthenselectthedesiredlabelgroup:

.Selectthegroupagainfor

, or

, thedesiredlabel. Thefirstnumbershowswhichlabelinthe groupisselected.Thesecondnumberisthe numberoflabelsavailable. SeeAnnotationssetuponpage 18. Toturnofftextentry,presstheTEXTkey. To reset the home position 1 PresstheTEXTkey. 2 Usingthetouchpadorarrowkeys,position thecursorwheredesired. 3 SelectHome/Set. To place an arrow on an image Youcanaddanarrowgraphictopointouta specificpartoftheimage. 1 PresstheARROWkey 2 Ifyouneedtoadjustthearrowsorientation,

. presstheSELECTkeyandthenusethe touchpad.Whentheorientationiscorrect, presstheSELECTkeyagain. 3 Usingthetouchpad,positionthearrowwhere desired. 4 PresstheARROWkeytosetthearrow. Thearrowchangesfromgreentowhite. Toremovethearrow,presstheARROWkeyand thenselectHide. To place a pictograph on an image Thepictographsetavailabledependson transducerandexamtype. 1 PressthePICTOkey. 2 Select x/xtodisplaythedesired pictograph,andthenpresstheSELECTkey. Thefirstnumbershowswhichpictographin thesetisselected.Thesecondnumberisthe numberofpictographsavailable. I m a g n g i 3 Usingthetouchpad,positionthepictograph marker. 4 (Optional)Torotatethepictographmarker, presstheSELECTkeyandthenusethe touchpad. 5 Selectascreenlocationforthepictograph:U/L

(Up/Left),D/L(Down/Left),D/R

(Down/Right),U/R(Up/Right). Inaduplexlayout,thepictographisrestricted toupperleft.InDual,allfourpositionsare available. Toremovethepictograph,selectHide. Patient information form Thepatientinformationformletsyouenter patientidentification,exam,andclinical informationforthepatientexam.This informationautomaticallyappearsinthepatient report. Whenyoucreateanewpatientinformationform, allimages,clips,andotherdatayousaveduring theexamarelinkedtothatpatient.(SeePatient reportonpage 68.) Chapter 3: Imaging 33 To create a new patient information form 1 PressthePATIENTkey. 2 Select 3 Fillintheformfields.SeePatient New/End. informationformfieldsonpage 34. 4 SelectDone. SeealsoToappendimagesandclipstoapatient examonpage 37. To edit a patient information form Youcaneditpatientinformationiftheexamhas notbeenarchivedorexportedandifthe informationisnotfromaworklist. SeealsoToeditpatientinformationfromthe patientlistonpage 36. 1 PressthePATIENTkey. 2 Makechangesasdesired. 3 Selectoneofthefollowing:

Canceltoundochangesandreturnto imaging. Donetosavechangesandreturnto imaging. To end the exam 1 Makesurethatyouhavesavedimagesand otherdatayouwanttokeep.(SeeSaving imagesandclipsonpage 35.) 2 PressthePATIENTkey. 3 Select New/End. Anewpatientinformationformappears. Patient information form fields Thepatientinformationformfieldsavailable dependonexamtype.Insomefieldsyoucan selectSymbolstoentersymbolsandspecial characters.SeeSymbolsonpage 10. Patient Last, First, Middle Patientname IDPatientidentificationnumber Accession Enternumber,ifapplicable. Date of birth Gender Indications Enterdesiredtext UserUserinitials Procedure (button)AvailableiftheDICOM Worklistfeatureislicensedandconfigured. SeetheDICOMuserguide. SelectBacktosaveentriesandreturntothe previousscreen. Exam Type Examtypesavailabledependon transducer.SeeImagingmodesandexams availablebytransduceronpage 31. LMP Estab. DD(OBorGynexam)InanOB exam,selectLMPorEstab. DDandthenenter eitherthedateofthelastmenstrualperiodor theestablishedduedate.InaGynexam,enter thedateofthelastmenstrualperiod.TheLMP datemustprecedethecurrentsystemdate. Twins (OBexam)SelecttheTwinscheckboxto displayTwin AandTwin Bmeasurementson thecalculationsmenuandforaccesstoTwin AandTwinBscreensforpreviousexamdata. Previous Exams (button)(OBexam)Displays fieldsforfivepreviousexams.Thedatefora previousexammustprecedethecurrent systemdate.Fortwins,selectTwin A/Bto togglebetweenTwinAandTwinBscreens.(If theTwin A/Boptiondoesnotappear,select Back,andmakesurethattheTwinscheckbox isselected.) SelectBacktosavechangesandreturntothe previousscreen. BP(Cardiac,IMT,Orbital,Transcranial,or Vascularexam)BloodPressure HR (Cardiac,Orbital,Transcranial,orVascular exam)HeartRate.Enterthebeatsperminute. 34 Patient information form Savingtheheartrateusingameasurement overwritesthisentry. Height (Cardiacexam)Thepatientheightin feetandinchesormetersandcentimeters.(To changetheunits,seePresetssetupon page 22.) Weight (Cardiacexam)Thepatientweightin poundsorkilos.(Tochangetheunits,see Presetssetuponpage 22.) BSA(Cardiacexam)BodySurfaceArea. Automaticallycalculatedafteryouenter heightandweight. Ethnicity (IMTexam)Ethnicorigin Reading Dr. Referring Dr. Institution Images and clips Saving images and clips Whenyousaveanimageorclip,itsavesto internalstorage.Thesystembeepsafterwardif BeepAlertison,andthepercentageiconflashes.

(SeeAudio,Batterysetuponpage 19.)Toaccess savedimagesandclips,openthepatientlist.(See Reviewingpatientexamsonpage 36.) Thepercentageiconinthesystemstatusarea showsthepercentageofspaceusedininternal storage.Toreceivealertswhenstorageisnear capacity,seeToreceivestoragealertson page 20. Toaccesssavedimagesandclips,openthe patientlist.SeeReviewingpatientexamson page 36. To save an image

PresstheSAVEkey. Theimagesavestointernalstorage. Bydefault,theSAVEkeysavesonlytheimage.As ashortcutduringcalculations,theSAVEkeycan saveboththeimagetointernalstorageandthe calculationtothepatientreport.SeePresets setuponpage 22. To capture and save a clip Clips,anoptionalfeature,letsyoucapture, preview,andsaveclips. 1 SetClipsoptions.(SeeTosetClipsoptions onpage 35.) 2 PresstheCLIPkey. Oneofthefollowingoccurs:

IfPrev/Offisselected,theclipsaves directlytointernalstorage. IfPrev/Onisselected,theclipplaysback inpreviewmode.Youcanselectanyofthe followingonscreen:

(1x, 1/2x, 1/4x) Aplaybackspeed Pausetointerruptplayback Left: xorRight: xtoremoveframes fromtheleftorrightsidesoftheclip

(wherexisthebeginningorending framenumber) Savetosavethecliptointernalstorage Deletetodeletetheclip I m a g n g i To set Clips options SettingClipsoptionsensuresthatclipsare capturedtoyourspecifications. 1 In2Dimagingmode,selectClipsonscreen. 2 Setoptionsasdesired. Chapter 3: Imaging 35 Clips options Time, ECG Preview On, Preview Off Prospective, Retrospective Time and ECG share the same location on-screen. With Time, capturing is based on number of seconds. Select the time duration. With ECG, capturing is based on the number of heart beats. Select the number of beats. PrevOn and PrevOff turn the preview feature on and off. With Prev/On, the captured clip automatically plays on-screen. The clip can be trimmed, saved, or deleted. With Prev/Off, the clip saves to internal storage, and the trim and delete options are not available. Pro and Retro determine how clips are captured:

With Pro, a clip is captured prospectively, after you press the CLIP key. With Retro, a clip is captured retrospectively, from pre-saved data before you press the CLIP key. Reviewing patient exams Caution:

If the internal storage icon does not appear in the system status area, internal storage may be defective. Contact SonoSite Technical Support. (See SonoSite Technical Support on page vii.) Thepatientlistorganizessavedimagesandclips inpatientexams.Youcandelete,view,print,or archiveexams.YoucanalsocopythemtoaUSB storagedevice. Figure 1 Patient List To display the patient list 1 PresstheREVIEWkey. 2 Ifthereisanactiveexam,selectListonscreen. To sort the patient list Afterthesystemstarts,thepatientlistisarranged bydateandtime,withthemostrecentpatientfile first.Youcanresortthepatientlistasneeded.

Selectthecolumnheadingthatyouwantto sortby.Selectitagainifsortinginreverse order. Note: The columnheadingisselectable. To select patients in the patient list

Usingthetouchpad,selectthecheckboxfor oneormorepatients. Select Allselectsallpatients. Todeselectpatients,selectcheckedboxesorClear All. To edit patient information from the patient list YoucaneditthepatientnameandIDfromthe patientlistinsteadoffromthepatient informationformiftheexamhasnotbeen exportedorarchived. 1 Inthepatientlist,selectthepatient. 36 Images and clips 2 SelectEdit. 3 Fillintheformfields,andselectOK. Printing, exporting, and deleting images and clips To append images and clips to a patient exam Althoughyoucannotaddimagesandclipstoa patientexamthatisended,exported,orarchived, youcanautomaticallystartanewpatientexam thathasthesamepatientinformation. Dependingonyourarchiver,thetwoexams appearasonestudywhenexportedorarchived. 1 Selecttheexaminthepatientlist. 2 SelectAppendonscreen. Anewpatientinformationformappears.The formhasthesameinformationastheexam youselected. To review images and clips Youcanreviewimagesandclipsinonlyone patientexamatatime. 1 Inthepatientlist,highlightthepatientexam whoseimagesandclipsyouwanttoreview. 2 SelectReviewonscreen. 3 Select x/xtocycletotheimageorclipyou wanttoreview. 4 (ClipOnly)SelectPlay. Theclipplaysautomaticallyafterloading. Theloadtimedependsoncliplength. YoucanselectPausetofreezetheclipandcan selectaplaybackspeed 1x, 1/2x, 1/4x. 5 Select x/xtocycletothenextimageorclip youwanttoview. Toreturntothepatientlist,selectList.Toreturn toimaging,selectDone. WARNING:

To avoid damaging the USB storage device and losing patient data from it, observe the following:

Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break. To print an image 1 Verifythataprinterisselected.SeeTo configurethesystemforaprinteron page 19. 2 Dooneofthefollowing:

Inthepatientlist,reviewthepatients images.SelectPrintwhentheimage appears. Withtheimagedisplayed,presstheA shortcutkey. Bydefault,theAshortcutkeyprints.To reprogramtheAandBshortcutkeys,see Presetssetuponpage 22. To print multiple images 1 Verifythataprinterisselected.SeeTo configurethesystemforaprinteron page 19. 2 Dooneofthefollowing:

Printallimagesformultiplepatients:

Selectoneormorepatientsinthepatient list.Thenselect Print. Printallimagesforonepatient:Highlight thepatientinthepatientlist,andthen selectPrint. Chapter 3: Imaging 37 I m a g n g i Eachimageappearsbrieflyonscreen whileprinting. To export patient exams to a USB storage device AUSBstoragedeviceisfortemporarystorageof imagesandclips.Patientexamsshouldbe archivedregularly.Tospecifyfileformat,see USBDevicessetuponpage 23. 1 InserttheUSBstoragedevice. 2 Inthepatientlist,selectthepatientexamsyou wanttoexport. 3 SelectExp. USB onscreen.AlistofUSB devicesappears. 4 SelecttheUSBstoragedevice.Ifyouwantto hidepatientinformation,deselectInclude patient information on images and clips. OnlyavailableUSBdevicesareselectable. 5 SelectExport. Thefilesarefinishedexporting approximatelyfivesecondsaftertheUSB animationstops.RemovingtheUSBstorage deviceorturningoffthesystemwhile exportingmaycauseexportedfilestobe corruptedorincomplete.Tostopinprogress exporting,selectCancel Export. To delete images and clips 1 Selectoneormorepatientsinthepatientlist. 2 SelectDeletetodeletetheselectedpatients.A confirmationscreenappears. To manually archive images and clips YoucansendpatientexamstoaDICOMprinter orarchiver,ortoaPCusingSiteLink.DICOM andSiteLinkareoptionalfeatures.Formore informationaboutarchiving,seetheSiteLinkand DICOMdocumentation. 1 Selectoneormorepatientsinthepatientlist. 2 SelectArchive. To display information about a patient exam 1 Onthepatientlist,selecttheexam. 2 Select Info. ECG Monitoring ECGMonitoringisanoptionalfeatureand requiresaSonoSiteECGcable. WARNING:

Caution:

To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms. The SonoSite ECG option is a non-diagnostic feature. To avoid electrical interference with aircraft systems, do not use the ECG cable on aircraft. Such interference may have safety consequences. Use only accessories recommended by SonoSite with the system. Your system can be damaged by connecting an accessory not recommended by SonoSite. To monitor ECG 1 ConnecttheECGcabletotheECGconnector ontheultrasoundsystem,minidock,or dockingsystem. ECGMonitoringturnsonautomatically. Note: AnexternalECGmonitormaycausealag inthetimingoftheECGtrace,correspondingwith the2Dimage.Biopsyguidelinesarenotavailable whenECGisconnected. 2 SelectECGonscreen.(ECGmaybeonanother page.ItappearsonlyiftheECGcableis connected.) 3 Selectoptionsasdesired. 38 ECG Monitoring ECG Monitoring options Show/Hide Turns on and off ECG trace. Gain Increases or decreases ECG gain. Settings are 0-20. Position Sets the position of the ECG trace. Sweep Speed Settings are Slow, Med, and Fast. Delay Line Save Displays Line and Save for clip acquisition delay. (For instructions to capture clips, see To capture and save a clip on page 35.) The position of the delay line on the ECG trace. The delay line indicates where the clip acquisition is triggered. Saves the current position of the delay line on the ECG trace. (You can change the position of the delay line temporarily. Starting a new patient information form or cycling system power reverts the delay line to the most recently saved position.) Select Delay to display these options. I m a g n g i Chapter 3: Imaging 39 40 ECG Monitoring Chapter 4: Measurements and Calculations Youcanmeasureforquickreference,oryoucan measurewithinacalculation.Youcanperform generalcalculationsaswellascalculations specifictoanexamtype. Measurementsareperformedonfrozenimages. Forreferencesused,seeChapter 7,References. Measurements Youcanperformbasicmeasurementsinany imagingmodeandcansavetheimagewiththe measurementsdisplayed.(SeeTosavean imageonpage 35.)ExceptfortheMModeHR measurement,theresultsdonotautomatically savetoacalculationandthepatientreport.Ifyou prefer,youcanfirstbeginacalculationandthen measure.SeePerformingandsaving measurementsincalculationsonpage 45. Someoptionsmaynotapplytoyoursystem. Optionsavailabledependonyourconfiguration, transducer,andexamtype. To save a measurement to a calculation and patient report 1 Withthemeasurementactive(green),press theCALCSkey. 2 Fromthecalculationsmenu,selecta measurementname. Onlymeasurementnamesavailableforthe imagingmodeandexamtypeareselectable. 3 Savethecalculation.(SeeTosavea calculationonpage 45.) Tostartacalculationbeforemeasuring,see Performingandsavingmeasurementsin calculationsonpage 45. Working with calipers Whenmeasuring,youworkwithcalipers,often inpairs.Resultsbasedonthecalipersposition appearatthebottomofthescreen.Theresults updateasyourepositionthecalipersbyusingthe touchpad.Intracemeasurements,theresults appearafteryoucompletethetrace. Outsideacalculation,youcanaddcalipersby pressingtheCALIPERkey.Youcanhavemultiple setsofcalipersandcanswitchfromonesetto another,repositioningthemasneeded.Eachset showsthemeasurementresult.Theactive calipersandmeasurementresultarehighlighted green.Ameasurementiscompletewhenyou finishmovingitscalipers. Withinacalculation,calipersappearwhenyou selectfromthecalculationsmenu.(SeeToselect fromthecalculationsmenuonpage 45.) Foranaccuratemeasurement,accurate placementofcalipersisessential. To switch the active calipers

Dooneofthefollowing:

Toswitchtheactivecaliperwithinaset, presstheSELECTkey. Toswitchtheactivesetwhenmeasuring outsideacalculation,selectSwitch onscreen. To delete or edit a measurement

Withthemeasurementactive(highlighted), dooneofthefollowing:

Todelete,selectDeleteonscreen. Toedit,usethetouchpadtomovethe calipers. Note: Tracemeasurementscannotbeeditedonceset. Chapter 4: Measurements and Calculations 41 M e a s u r e m e n t s To improve precision of caliper placement

Doanyofthefollowing:

Adjustthedisplayformaximum sharpness. Useleadingedges(closesttothe transducer)orbordersforstartingand stoppingpoints. Maintainaconsistenttransducer orientationforeachtypeofmeasurement. Makesurethattheareaofinterestfillsas muchofthescreenaspossible.

(2D)Minimizethedepth,orzoom. 2D measurements Thebasicmeasurementsthatyoucanperformin 2Dimagingareasfollows:

Distanceincm Areaincm2 Circumferenceincm Youcanalsomeasureareaorcircumferenceby tracingmanually. Figure 1 2D image with two distance and one circumference measurement Youcanperformacombinationofdistance,area, circumference,andmanualtracemeasurements atonetime.Thetotalnumberpossibledepends ontheirorderandtype. To measure distance (2D) Youcanperformuptoeightdistance measurementsona2Dimage. 1 Onafrozen2Dimage,presstheCALIPERkey. Apairofcalipersappears,connectedbya dottedline. 2 Usingthetouchpad,positionthefirstcaliper, andthenpresstheSELECTkey. Theothercaliperbecomesactive. 3 Usingthetouchpad,positiontheothercaliper. Ifyoumovethecalipersclosetogether,they shrinkandthedottedlinedisappears. SeeTosaveameasurementtoacalculationand patientreportonpage 41. To measure area or circumference (2D) 1 Onafrozen2Dimage,presstheCALIPERkey. 2 SelectEllipseonscreen. Note: Ifyouexceedtheallowednumberof measurements,Ellipseisnotavailable. 3 Usethetouchpadtoadjustthesizeand positionoftheellipse.TheSELECTkeytoggles betweenpositionandsize. SeeTosaveameasurementtoacalculationand patientreportonpage 41. To trace manually (2D) 1 Onafrozen2Dimage,presstheCALIPERkey. 2 SelectManualonscreen. Note: Ifyouexceedtheallowednumberof measurements,Manualisnotavailable. 3 Usingthetouchpad,positionthecaliper whereyouwanttobegin. 42 Measurements 4 PresstheSELECTkey. 5 Usingthetouchpad,completethetrace,and presstheSETkey. SeeTosaveameasurementtoacalculationand patientreportonpage 41. 4 PresstheSELECTkey. Asecondverticalcaliperappears. 5 Usingthetouchpad,positionthesecond verticalcaliperatthepeakofthenext heartbeat. M Mode measurements Thebasicmeasurementsthatyoucanperformin M Modeimagingareasfollows:

Distanceincm/Timeinseconds HeartRate(HR)inbeatsperminute(bpm) Thetimescaleabovethetracehassmallmarksat 200 msintervalsandlargemarksatonesecond intervals. To measure distance (M Mode) Youcanperformuptofourdistance measurementsonanimage. 1 OnafrozenM Modetrace,presstheCALIPER key. Asinglecaliperappears. 2 Usingthetouchpad,positionthecaliper. 3 PresstheSELECTkeytodisplaythesecond caliper. 4 Usingthetouchpad,positionthesecond caliper. SeeTosaveameasurementtoacalculationand patientreportonpage 41.Savingtheheartrate measurementtothepatientreportoverwrites anyheartrateenteredonthepatientinformation form. SeealsoTomeasurefetalheartrate(MMode) onpage 63. Doppler measurements Thebasicmeasurementsthatyoucanperformin DopplerimagingareVelocity(cm/s),Pressure Gradient,ElapsedTime,+/xRatio,Resistive Index (RI),andAcceleration.Youcanalsotrace manuallyorautomatically. ForDopplermeasurements,theDopplerscale mustbesettocm/s.SeePresetssetupon page 22. To measure Velocity (cm/s) and Pressure Gradient (Doppler) 1 OnafrozenDopplerspectraltrace,pressthe CALIPERkey. Asinglecaliperappears. SeeTosaveameasurementtoacalculationand patientreportonpage 41. 2 Usingthetouchpad,positionthecalipertoa peakvelocitywaveform. To measure heart rate (M Mode) 1 OnafrozenM Modetrace,presstheCALIPER key. 2 SelectHRonscreen. Averticalcaliperappears. 3 Usingthetouchpad,positionthevertical caliperatthepeakoftheheartbeat. Thismeasurementinvolvesasinglecaliperfrom thebaseline. SeeTosaveameasurementtoacalculationand patientreportonpage 41. M e a s u r e m e n t s Chapter 4: Measurements and Calculations 43 To measure Velocities, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration

(Doppler) 1 OnafrozenDopplerspectraltrace,pressthe CALIPERkey. Asinglecaliperappears. 2 Usingthetouchpad,positionthecalipertoa peaksystolicwaveform. 3 PresstheSELECTkey. Asecondcaliperappears. 4 Usingthetouchpad,positionthesecond caliperattheenddiastoleonthewaveform. SeeTosaveameasurementtoacalculationand patientreportonpage 41. To measure time duration (Doppler) 1 OnaDopplerspectraltrace,presstheCALIPER key. 2 PressTimeonscreen. 3 Averticalcaliperappears. 4 Usingthetouchpad,positionthecaliper wheredesired,andpresstheSELECTkey. 5 Asecondcaliperappears. 6 Usingthetouchpad,positionthesecond caliperwheredesired,andpresstheSELECT key. To trace manually (Doppler) 1 OnafrozenDopplerspectraltrace,pressthe CALIPERkey. 2 SelectManualonscreen. Asinglecaliperappears. 3 Usingthetouchpad,positionthecaliperatthe beginningofthedesiredwaveform,andpress theSELECTkey. Ifcalipersarenotpositionedcorrectly,the resultisinaccurate. 4 Usingthetouchpad,tracethewaveform. Tomakeacorrection,selectUndoonscreen, backtrackwiththetouchpad,orpressthe BACKSPACEkey. 5 PresstheSETkey. Themeasurementresultsappear. SeeTosaveameasurementtoacalculationand patientreportonpage 41. To trace automatically (Doppler) Aftertracingautomatically,confirmthatthe systemgeneratedboundaryiscorrect.Ifyouare notsatisfiedwiththetrace,obtainahighquality Dopplerspectraltraceimage,ortracemanually.

(SeeTotracemanually(Doppler)onpage 44.) 1 OnafrozenDopplerspectraltrace,pressthe CALIPERkey. 2 SelectAutoonscreen. Averticalcaliperappears. 3 Usingthetouchpad,positionthecaliperatthe beginningofthewaveform. Ifcalipersarenotpositionedcorrectly,the calculationresultisinaccurate. 4 PresstheSELECTkey. Asecondverticalcaliperappears. 5 Usingthetouchpad,positionthesecond caliperattheendofthewaveform. 6 PresstheSETkey. Themeasurementresultsappear. SeeTosaveameasurementtoacalculationand patientreportonpage 41. Automatic trace results Dependingontheexamtype,theresultsfrom automatictracingincludethefollowing:

VelocityTimeIntegral(VTI) PeakVelocity(Vmax) 44 Measurements MeanPressureGradient(PGmean) MeanVelocityonPeakTrace(Vmean) PressureGradient(PGmax) CardiacOutput(CO) PeakSystolicVelocity(PSV) TimeAverageMean(TAM)*

+/orSystolic/Diastolic(S/D) PulsatilityIndex(PI) EndDiastolicVelocity(EDV) AccelerationTime(AT) ResistiveIndex(RI) TimeAveragePeak(TAP) GateDepth General calculations Withincalculations,youcansavemeasurement resultstothepatientreport.Youcandisplay, repeat,anddeletemeasurementsfroma calculation.Somemeasurementscanbedeleted directlyfromthepatientreportpages.See Patientreportonpage 68. Calculationpackagesdependonexamtypeand transducer. Calculations menu Thecalculationsmenucontainsmeasurements availablefortheimagingmodeandexamtype. Afteryouperformandsaveameasurement,the resultsavestothepatientreport.(SeePatient reportonpage 68.)Also,acheckmarkappears nexttothemeasurementnameinthecalculations menu.Ifyouhighlightthecheckedmeasurement name,theresultsappearbelowthemenu.Ifyou repeatthemeasurement,theresultsbelowthe menureflecteitherthelastmeasurementorthe average,dependingonthemeasurement. Menuitemsfollowedbyellipses(...)have subentries. To select from the calculations menu 1 Onafrozenimage,presstheCALCSkey. Thecalculationsmenuappears. 2 Usingthetouchpadorarrowkeys,highlight thedesiredmeasurementname. Todisplayadditionalmeasurementnames, highlightNext,Prev,orameasurementname thathasellipses(...).ThenpresstheSELECT key. Onlymeasurementnamesavailableforthe imagingmodeareselectable. 3 PresstheSELECTkey. Toclosethecalculationsmenu,presstheCALCS keyonce(ifthemenuisactive)ortwice(ifthe menuisinactive). Performing and saving measurements in calculations Inperformingameasurementwithina calculation,youselectfromthecalculations menu,positionthecalipersthatappear,andthen savethecalculation.Unlikemeasurements performedoutsideacalculation,thecalipers appearbyselectingfromthecalculationsmenu, notbypressingtheCALIPERkey.Thetypeof calipersthatappeardependsonthe measurement. To save a calculation

Dooneofthefollowing:

Savethecalculationonly:Pressthe SAVE CALCkey,orselectSaveonscreen. Thecalculationsavestothepatientreport. Tosavetheimagewiththemeasurements displayed,seeTosaveanimageon page 35. Saveboththeimageandcalculation:Press theSAVE keyiftheSAVEkeyfunctionality Chapter 4: Measurements and Calculations 45 M e a s u r e m e n t s issettoImage/Calcs.(SeePresetssetup onpage 22.) Thecalculationsavestothepatientreport, andtheimagesavestointernalstorage withthemeasurementsdisplayed. Displaying, repeating, and deleting saved measurements in calculations To display a saved measurement

Dooneofthefollowing:

Highlightthemeasurementnameinthe calculationsmenu.Theresultappears belowthemenu. Openthepatientreport.SeePatientreporton page 68. To repeat a saved measurement 1 Highlightthemeasurementnameinthe calculationsmenu. 2 PresstheSELECTkeyortheCALIPERkey. 3 Performthemeasurementagain. Thenewresultsappearonscreeninthe measurementandcalculationsdataarea.(See Screenlayoutonpage 7.)Youcancompare themtothesavedresultsbelowthemenu. 4 Tosavethenewmeasurement,pressthe SAVE CALCkey. Thenewmeasurementsavestothepatient reportandoverwritesthepreviouslysaved measurement. To delete a saved measurement 1 Selectthemeasurementnamefromthe calculationsmenu. 2 SelectDeleteonscreen. Themeasurementlastsavedisdeletedfrom thepatientreport.Ifitistheonly measurement,thecheckmarkisdeletedfrom thecalculationsmenu. Somemeasurementscanbedeleteddirectlyfrom thepatientreportpages.SeePatientreporton page 68. EMED calculations TheresultsfromEMEDcalculations automaticallyappearintheEMEDworksheets. AllEMEDcalculationsareavailableforeach examtype. To perform an EMED calculation:

1 PresstheCALCSkey. 2 SelectEMEDonscreen. ThecalculationsmenubecomestheEMED calculationsmenu. 3 Selectthecalculationname. 4 Performadistancemeasurement. 5 Savethemeasurement. Toreturntothecalculationsmenu,selectCalcs onscreen. Percent reduction calculations WARNING:

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. 46 General calculations Transducer Exam Types C11x C60x Abdomen Abdomen HFL38x IMT, Small Parts, Vascular L25x L38x P10x P21x SLAx Vascular, Muscle IMT, Small Parts, Vascular Abdomen Abdomen Muscle, Vascular b Usingthetouchpad,movethecaliperto thetracestartingpoint,andpressthe SELECTkey. c Usingthetouchpad,tracethedesiredarea. Tomakeacorrection,selectUndo onscreenorpresstheBACKSPACEkey. d Completethetrace,andpresstheSETkey. e Savethecalculation.SeeTosavea calculationonpage 45. Thepercentareareductionresultappears onscreeninthemeasurementandcalculation dataareaandinthepatientreport. To calculate percent diameter reduction 1 Onafrozen2Dimage,presstheCALCSkey. 2 DothefollowingforD1andthenforD2:

a Fromthecalculationsmenu,selectthe measurementnameunderDia Red. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.SeeTosavea calculationonpage 45. Thepercentdiameterreductionresultappearsin themeasurementandcalculationdataareaand inthepatientreport. Figure 2 Percent area reduction calculation of right carotid bulb To calculate percent area reduction Thepercentareareductioncalculationinvolves twomanualtracemeasurements. 1 Onafrozen2Dimage,presstheCALCSkey. 2 DothefollowingforA1andthenforA2:

a Fromthecalculationsmenu,selectthe measurementnameunderArea Red. M e a s u r e m e n t s Chapter 4: Measurements and Calculations 47 Volume calculations WARNING:

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. To calculate volume Thevolumecalculationinvolvesthree2D distancemeasurements:D1,D2,andD3.Afterall measurementsaresaved,theresultappears onscreenandinthepatientreport.

Dothefollowingforeachimageyouneedto measure:

a Onthefrozen2Dimage,presstheCALCS key. b Dothefollowingforeachmeasurement youneedtotake:

i Fromthecalculationsmenu,selectthe measurementnameunderVolume.(If VolumeisnotavailableinaGynexam, selectGynandthenselectVolume.) ii Positionthecalipers.(SeeWorking withcalipersonpage 41.) Transducer Exam Types iii Savethemeasurement.SeeTosavea calculationonpage 45. C11x C60x HFL38x ICTx L25x L38x P10x P21x SLAx Abdomen, Nerve Volume flow calculations Abdomen, Gyn, Nerve WARNING:

Breast, Nerve, Small Parts, Vascular Gyn Muscle, Nerve, Vascular, Superficial, Breast, Nerve, Small Parts, Vascular Abdomen, Neonatal Abdomen Muscle, Nerve, Superficial, Vascular To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. 48 General calculations Transducer Exam Types C11x C60x HFL38x L25x L38x P10x P21x SLAx Abdomen Abdomen Vascular Vascular Vascular Abdomen Abdomen Vascular Thefollowingtableshowsthemeasurements requiredtocompletethevolumeflow calculation.Fordefinitionsofacronyms,see Glossaryonpage 157. Volume Flow Calculations Menu Heading Vol Flow Measurement

(Imaging Mode) Calculation Result D (2D) TAM (Doppler) VF (Volume Flow l/min) Botha2DandaDopplermeasurementare requiredforthevolumeflowcalculation.The Dopplersamplevolumeshouldcompletely insonatethevessel. Considerthefollowingfactorswhenperforming volumeflowmeasurements:

Usersshouldfollowcurrentmedicalpractice forvolumeflowcalculationapplications. Theaccuracyofthevolumeflowcalculation largelydependsontheuser. Thefactorsidentifiedintheliteraturethat affecttheaccuracyareasfollows:

Usingthediametermethodfor2Darea Difficultyensuringuniforminsonationof thevessel. Thesystemislimitedtothefollowing samplevolumesizes:

C11xtransducer:1,2,3GateSize(mm) C60xandP10xtransducers:2,3,5,7, 10,12GateSize(mm) HFL38x,L25x,L38x,andSLAx transducers:1,3,5,7,10,12GateSize

(mm) P21xtransducer:2,3,5,7,11.5,14Gate Size(mm) Precisioninplacingthecaliper Accuracyinanglecorrection Theconsiderationsanddegreeofaccuracyfor volumeflowmeasurementsandcalculationsare discussedinthefollowingreference:

Allan,PaulL.etal.ClinicalDopplerUltrasound, 4thEd.,HarcourtPublishersLimited,(2000) 3638. To calculate volume flow 1 Performthe2Dmeasurement:

a Onafrozenfullscreen2Dimageorduplex image,presstheCALCSkey. b Fromthecalculationsmenu,selectD

(distance)underVol Flow. c Positionthecalipers.(SeeWorkingwith calipersonpage 41.) d Savethecalculation.SeeTosavea calculationonpage 45. 2 PerformtheDopplermeasurement:

a OnafrozenDopplerspectraltrace,press theCALCSkey. b Fromthecalculationsmenu,selectTAM underVol Flow. Averticalcaliperappears. Chapter 4: Measurements and Calculations 49 M e a s u r e m e n t s c Usingthetouchpad,positionthevertical caliperatthebeginningofthewaveform. Ifcalipersarenotpositionedcorrectly,the calculationresultisinaccurate. d PresstheSELECTkeytodisplayasecond verticalcaliper. e Usingthetouchpad,positionthesecond verticalcaliperattheendofthewaveform. f PresstheSETkeytocompletethetraceand todisplaytheresults. g Savethecalculation.SeeTosavea calculationonpage 45. Todisplaythevolumeflowcalculation,see Patientreportonpage 68. Exam-based calculations Inadditiontothegeneralcalculations,thereare calculationsspecifictotheCardiac,Gynecology

(Gyn),IMT,OB,Orbital,SmallParts,Transcranial Doppler(TCD),andVascularexamtypes. Cardiac calculations WARNING:

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. Transducer Exam Type D2x P10x P21x TEEx Cardiac Cardiac Cardiac Cardiac Thefollowingtableshowsthemeasurements requiredtocompletedifferentcardiac calculations.Fordefinitionsofacronyms,see Glossaryonpage 157. Cardiac Calculations Menu Heading LVLVd LVs Ao/LA Cardiac Measurements

(Imaging Mode) Calculation Results RVW (2D) RVD (2D) IVS (2D) LVD (2D) LVPW (2D) RVW (2D) RVD (2D) IVS (2D) LVD (2D) LVPW (2D) HRa needed for CO & CI Ao (2D or M Mode) AAo (2D) LA (2D or M Mode) LVOT D (2D) CO EF SV LVESV LVEDV IVSFT LVPWFT LVDFS CI SI Ao LA/Ao AAo LA LA/Ao LVOT D LVOT area 50 Exam-based calculations Menu Heading Cardiac Measurements

(Imaging Mode) Calculation Results ACS (M Mode) LVET (M Mode) ACS LVET MV EF:Slope

(M Mode) EF SLOPE EPSS (M Mode) EPSS LVLVd LVs HR Area LV Vol

(EF) RVW (M Mode) RVD (M Mode) IVS (M Mode) LVD (M Mode) LVPW (M Mode) RVW (M Mode) RVD (M Mode) IVS (M Mode) LVD (M Mode) LVPW (M Mode) HRa AV (2D) MV (2D) A4Cd (2D) A4Cs (2D) A2Cd (2D) A2Cs (2D) LV mass Epi (2D) Endo (2D) Apical (2D) CO EF SV LVESV LVEDV IVSFT LVPWFT LVDFS CI SI LV Mass AV Area MV Area LV Vol LV Area EF CO SV CI SI Biplane LV Mass Epi Area Endo Area D Apical Calculation Results PISA Area ERO MV Rate Regurgitant Volume Regurgitant Fraction D VTI VMax PGmax Vmean PGmean SV Qp/Qs E(MV)/e ratio Menu Heading PISA Cardiac Measurements

(Imaging Mode) Ann D (2D) Radius (Color) MR/VTI (Doppler) MV/VTI (Doppler) Qp/Qs TDI LVOT D (2D) RVOT D (2D) LVOT VTI

(Doppler) RVOT VTI

(Doppler)

(Wall) e and a

(Doppler)

(Wall) e and a

(Doppler)

(Wall) e and a

(Doppler)

(Wall) e and a

(Doppler)

(Wall) e and a

(Doppler) M e a s u r e m e n t s Chapter 4: Measurements and Calculations 51 Menu Heading Cardiac Measurements

(Imaging Mode) Calculation Results Menu Heading Cardiac Measurements

(Imaging Mode) Calculation Results P. Vein A (Doppler) MV Adur (Doppler) S (Doppler) D (Doppler) E (Doppler) A (Doppler) Adur (Doppler) PHT (Doppler) VTI (Doppler) IVRT (Doppler) MVMR dP:dTb (CW Doppler) VMax time VMax S/D ratio E E PG A A PG E:A time PHT MVA Decel time VTI Vmax PGmax Vmean PGmean time dP:dT AV Vmax (Doppler) VTI (Doppler) VTI or Vmax from LVOT (Doppler) VTI or Vmax from AV (Doppler) Vmax PGmax VTI Vmax PGmax Vmean PGmean AVA Ao/LA LVOT D (2D) AV VTI (Doppler) SV Ao/LA LVOT D (2D) AV VTI (Doppler) CO Ao/LA LVOT D (2D) HR LVOT HRa Vmax (Doppler) VTI (Doppler) AVAI PHT (slope)

(Doppler) Vmax PGmax VTI Vmax PGmax Vmean PGmean AI PHT AI slope 52 Exam-based calculations Menu Heading Cardiac Measurements

(Imaging Mode) Calculation Results TV TRmax (Doppler) E (Doppler) A (Doppler) PHT (Doppler) VTI (Doppler) RA pressurec PV Vmax (Doppler) VTI (Doppler) AT (Doppler) Vmax PGmax E E PG A A PG E:A PHT MVA Decel time VTI Vmax PGmax Vmean PGmean RVSP Vmax PGmax VTI Vmax PGmax Vmean PGmean AT a. You can enter the HR measurement three ways: Patient information form, Doppler measurement (See To calculate Heart Rate (HR) on page 57), or M Mode measurement (See To measure heart rate (M Mode) on page 43). b. Performed at 100 cm/s and 300 cm/s. c. Specified on the cardiac patient report. See To delete a vascular or cardiac measurement on page 69. To measure LVd and LVs 1 Onafrozen2DimageorM Modetrace,press theCALCSkey. 2 Fromthecalculationsmenu,selectthe measurementname. 3 Positiontheactive(green)caliperatthe startingpoint.(SeeWorkingwithcalipers onpage 41.) 4 PresstheSELECTkey,andpositionthesecond caliper. 5 PresstheSELECTkey. Anothercaliperappears,andthecalculations menuhighlightsthenextmeasurementname. 6 Positionthecaliper,andpresstheSELECTkey. Repeatforeachmeasurementnameinthe calculationgroup. EachtimeyoupresstheSELECTkey,another caliperappears,andthecalculationsmenu highlightsthenextmeasurementname. 7 Savethecalculation.(SeeTosavea calculationonpage 45.) To measure Ao, LA, AAo, or LVOT D 1 Onafrozen2DimageorM Modetrace,press theCALCSkey. 2 Fromthecalculationsmenu,selectthe measurementname. 3 Positionthecalipers.(SeeWorkingwith calipersonpage 41.) 4 Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate LV Volume (Simpsons Rule) 1 Onafrozen2Dimage,presstheCALCSkey. 2 Dothefollowingforeachmeasurement:

a Fromthecalculationsmenu,selectthe desiredviewandphase. b Positionthecaliperatthemitralannulus, andpresstheSELECTkeytostartthetrace. Chapter 4: Measurements and Calculations 53 M e a s u r e m e n t s c Usingthetouchpad,tracetheleft ventricular(LV)cavity. Tomakeacorrection,selectUndoonscreen orpresstheBACKSPACEkey. d Completethetrace,andpresstheSETkey. e Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate MV or AV area 1 Onafrozen2Dimage,presstheCALCSkey. 2 Inthecalculationsmenu,locateArea,and thenselectMVorAV. 3 Positionthecaliperwhereyouwanttobegin thetrace,andpresstheSELECTkey. 4 Usingthetouchpad,tracethedesiredarea. Tomakeacorrection,selectUndoonscreenor presstheBACKSPACEkey. 5 Completethetrace,andpresstheSETkey. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate LV Mass 1 Onafrozen2Dimage,presstheCALCSkey. 2 Inthecalculationsmenu,locateLV Mass. 3 DothefollowingforEPIandthenforEndo:

a Selectthemeasurementnamefromthe calculationsmenu. b Positionthecaliperwhereyouwantto beginthetrace,andpresstheSELECTkey. c Usingthetouchpad,tracethedesiredarea. Tomakeacorrection,selectUndo onscreenorpresstheBACKSPACEkey. d Completethetrace,andpresstheSETkey. e Savethecalculation.(SeeTosavea calculationonpage 45.). 4 SelectApical fromthecalculationsmenu. 5 Positioningthecalipers,measurethe ventricularlength.(SeeWorkingwith calipersonpage 41.) 6 Savethecalculation. To measure peak velocity Foreachcardiacmeasurement,thesystemsaves uptofiveindividualmeasurementsand calculatestheiraverage.Ifyoutakemorethan fivemeasurements,themostrecentmeasurement replacesthefifthone.Ifyoudeleteasaved measurementfromthepatientreport,thenext measurementtakenreplacesthedeletedonein thepatientreport.Themostrecentlysaved measurementappearsatthebottomofthe calculationsmenu. 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectMV,TV,or TDI,orP. Vein. 3 Dothefollowingforeachmeasurementyou wanttotake:

a Selectthemeasurementnamefromthe calculationsmenu. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate Velocity Time Integral (VTI) Note: Thiscalculationcomputesotherresultsin additiontoVTI.SeethetableCardiacCalculations onpage 50. 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectVTI under MV,AV,TV,PV,orLVOT. 3 Positionthecaliperatthestartofthe waveform,andpresstheSELECTkeytostart thetrace. 54 Exam-based calculations 4 Usingthetouchpad,tracethewaveform. Tomakeacorrection,selectUndoonscreen, backtrackwiththetouchpad,orpressthe BACKSPACEkey. InAV,positionthecaliperattheend diastole. 5 Savethecalculation.(SeeTosavea calculationonpage 45.) 5 PresstheSETkeytocompletethetrace. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) Forinformationontheautomatictracetool,see Totraceautomatically(Doppler)onpage 44. To calculate Right Ventricular Systolic Pressure (RVSP) 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectTVand thenselectTRmax. 3 Positionthecaliper.(SeeWorkingwith calipersonpage 41.) 4 Savethecalculation.(SeeTosavea calculationonpage 45.) 5 ToadjusttheRApressure,seeTodeletea vascularorcardiacmeasurementonpage 69. ChangingtheRApressurefromthedefault5 affectstheRVSPcalculationinthepatient report. To calculate Pressure Half Time (PHT) in MV, AI, or TV 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectMV, AV,or TV,andthenselectPHT. 3 Positionthefirstcaliperatthepeak,andpress theSELECTkey. Asecondcaliperappears. 4 Positionthesecondcaliper:

InMV,positionthecaliperalongtheEF slope. To calculate Proximal Isovelocity Surface Area (PISA) ThePISAcalculationrequiresameasurementin 2D,ameasurementinColor,andtwo measurementsinDopplerspectraltrace.Afterall measurementsaresaved,theresultappearsin thepatientreport. 1 MeasurefromAnnD(2D):

a Onafrozen2Dimage,presstheCALCSkey. b Fromthecalculationsmenu,locatePISA, andthenselectAnn D. c Positionthecalipers.(SeeWorkingwith calipersonpage 41.) d Savethecalculation.(SeeTosavea calculationonpage 45.) 2 MeasurefromRadius(Color):

a OnafrozenColorimage,presstheCALCS key. b Fromthecalculationsmenu,selectRadius. c Positionthecalipers. d Savethecalculation. 3 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 4 DothefollowingtomeasurefromMRVTI andagaintomeasurefromMVVTI(Doppler):

a Fromthecalculationsmenu,selectPISA andthenselectMR VTI orMV VTI. b Positionthecaliperatthestartofthe waveform,andpresstheSELECTkeyto startthetrace. c Usingthetouchpad,tracethewaveform. Chapter 4: Measurements and Calculations 55 M e a s u r e m e n t s Tomakeacorrection,selectUndo onscreen,backtrackwiththetouchpad,or presstheBACKSPACEkey. d PresstheSETkeytocompletethetrace. e Savethecalculation. 4 PresstheSELECTkey. Asecondhorizontaldottedlinewithanactive caliperappearsat300cm/s. 5 Positionthesecondcaliperalongthe waveformat300cm/s. Forinformationontheautomatictracetool,see Totraceautomatically(Doppler)onpage 44. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate Isovolumic Relaxation Time

(IVRT) 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectMVand thenselectIVRT. Averticalcaliperappears. 3 Usingthetouchpad,positionthecaliperatthe aorticvalveclosure. 4 PresstheSELECTkey. Asecondverticalcaliperappears. 5 Usingthetouchpad,positionthesecond caliperatonsetofmitralinflow. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate Delta Pressure: Delta Time

(dP:dT) ToperformthedP:dTmeasurements,theCW Dopplerscalemustincludevelocitiesof300 cm/s orgreateronthenegativesideofthebaseline.

(SeeSpectraltraceoptionsonpage 29.) 1 OnafrozenCWDopplerspectraltrace,press theCALCSkey. 2 Fromthecalculationsmenu,selectMV,and thenselectdP:dT. Ahorizontaldottedlinewithanactivecaliper appearsat100cm/s. 3 Positionthefirstcaliperalongthewaveform at100cm/s. To calculate Aortic Valve Area (AVA) TheAVAcalculationrequiresameasurementin 2DandtwomeasurementsinDoppler.Afterthe measurementsaresaved,theresultappearsin thepatientreport. 1 MeasurefromLVOT(2D):

a Onafrozen2Dimage,presstheCALCSkey. b Fromthecalculationsmenu,selectLVOT D. c Positionthecalipers.(SeeWorkingwith calipersonpage 41.) d Savethecalculation.(SeeTosavea calculationonpage 45.) 2 MeasurefromLVOT,andthenmeasurefrom AV(Doppler):

ForVmax,seeTomeasurepeakvelocity onpage 54.Fromthecalculationsmenu, selectAV,selectsamplesite,andthen selectVmax. ForVTI,seeTocalculateVelocityTime Integral(VTI)onpage 54.Fromthe calculationsmenu,selectAV,selectsample site,andthenselectVTI. To calculate Qp/Qs TheQp/Qscalculationrequirestwo measurementsin2Dandtwomeasurementsin Doppler.Afterthemeasurementsaresaved,the resultappearsinthepatientreport. 1 Onafrozen2Dimage,presstheCALCSkey. 2 DothefollowingtomeasurefromLVOTD andagaintomeasurefromRVOT D:

56 Exam-based calculations a Fromthecalculationsmenu,locateQp/Qs andthenselectLVOT D or RVOT D. c Positionthecalipers.(SeeWorkingwith calipersonpage 41.) b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) d Savethecalculation.(SeeTosavea calculationonpage 45.) c Savethecalculation.(SeeTosavea calculationonpage 45.) 3 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 4 DothefollowingtomeasurefromLVOTVTI andagaintomeasurefromRVOTVTI:

a Fromthecalculationsmenu,selectQp/Qs andthenselectLVOT VTI or RVOT VTI. b PresstheSELECTkeytostartthetrace. c Usingthetouchpad,tracethewaveform. Tomakeacorrection,selectUndo onscreen,backtrackwiththetouchpad,or presstheBACKSPACEkey. d PresstheSETkeytocompletethetrace. e Savethecalculation.(SeeTosavea calculationonpage 45.) Forinformationontheautomatictracetool,see Totraceautomatically(Doppler)onpage 44. To calculate Stroke Volume (SV) or Stroke Index (SI) TheSVandSIcalculationsrequirea measurementin2Dandameasurementin Doppler.SIalsorequiresBodySurfaceArea

(BSA).Afterthemeasurementsaresaved,the resultappearsinthepatientreport. 1 (SIOnly)FillintheHeightandWeightfields onthepatientinformationform.TheBSAis calculatedautomatically.(SeeTocreatea newpatientinformationformonpage 34.) 2 MeasurefromLVOT(2D):

a Onafrozen2Dimage,presstheCALCSkey. b Fromthecalculationsmenu,selectLVOT D. 3 Measurefromaorta(Doppler).SeeTo calculateVelocityTimeIntegral(VTI)on page 54.Fromthecalculationsmenu,select AVandthenselectVTI. Forinformationontheautomatictracetool,see Totraceautomatically(Doppler)onpage 44. To calculate Heart Rate (HR) HeartRateisavailableinallcardiacpackages. TheHeartRateisnotcalculatedusingtheECG trace. Savingtheheartratetothepatientreport overwritesanyheartrateenteredonthepatient informationform. 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectHR. Averticalcaliperappears. 3 Usingthetouchpad,positionthefirstvertical caliperatthepeakoftheheartbeat. 4 PresstheSELECTkey. Asecondverticalcaliperappears.Theactive caliperishighlightedgreen. 5 Usingthetouchpad,positionthesecond verticalcaliperatthepeakofthenext heartbeat. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) To calculate Cardiac Output (CO) or Cardiac Index (CI) TheCOandCIcalculationsrequireStroke VolumeandHeartRatecalculations.CIalso requiresBodySurfaceArea(BSA).Afterthe measurementsaresaved,theresultappearsin thepatientreport. Chapter 4: Measurements and Calculations 57 M e a s u r e m e n t s 1 (CIOnly)FillintheHeightandWeightfields onthepatientinformationform.TheBSAis calculatedautomatically.(SeeTocreatea newpatientinformationformonpage 34.) 2 CalculateSV.SeeTocalculateStrokeVolume

(SV)orStrokeIndex(SI)onpage 57. 3 CalculateHR.SeeTocalculateHeartRate

(HR)onpage 57. To measure a Tissue Doppler Imaging (TDI) waveform 1 EnsurethatTDIison.(SeePWDoppler optionsonpage 29.) 2 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 3 Fromthecalculationsmenu,selectTDI,and thendothefollowingforeachmeasurement youwanttotake:

a Fromthecalculationsmenu,selectthe measurementname. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.(SeeTosavea calculationonpage 45.) Gynecology (Gyn) calculations Gynecology(Gyn)calculationsincludeUterus, Ovary,Follicle,andVolume.Forinstructionsto calculatevolume,seeVolumecalculationson page 48. WARNING:

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. Transducer Exam Type C60x ICTx Gyn Gyn To measure uterus or ovary 1 Onafrozen2Dimage,presstheCALCSkey. 2 Fromthecalculationsmenu,selectGyn. 3 Dothefollowingforeachmeasurementyou wanttotake:

a Selectthemeasurementnamefromthe calculationsmenu. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.(SeeTosavea calculationonpage 45.) 58 Exam-based calculations To measure follicles Youcansaveuptosixfollicularmeasurements, onedistancemeasurementforeachofuptosix follicles. 1 Onafrozen2Dimage,presstheCALCSkey. 2 Fromthecalculationsmenu,selectFollicle. 3 Dothefollowingforeachfollicleyouwantto measure:

a Fromthecalculationsmenu,selectthe measurementnameunderRight FolorLeft Fol. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.(SeeTosavea calculationonpage 45.) To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. IMT calculations Transducer Exam Type WARNING:

To ensure high quality images, all patient images must be obtained by qualified and trained individuals. L38x HFL38x IMT IMT Thefollowingtableshowsavailable measurementsforIMTcalculations.TheIMT measurementnamesarespecifiedontheIMT setuppage.SeeIMTCalculationssetupon page 20. To avoid patient injury, IMT results should not be used as a sole diagnostic tool. All IMT results should be interpreted in conjunction with other clinical information or risk factors. To avoid measurement errors, all measurements must be of the common carotid artery (CCA). This tool is not intended for measuring the bulb or the internal carotid artery (ICA). M e a s u r e m e n t s Chapter 4: Measurements and Calculations 59 IMT Calculations (2D) Menu Heading Available Measurements Right-IMT Left-IMT Ant N (Anterior Near Wall) Ant F (Anterior Far Wall) Lat N (Lateral Near Wall) Lat F (Lateral Far Wall) Post N (Posterior Near Wall) Post F (Posterior Far Wall) IMT 1 IMT 2 IMT 3 IMT 4 IMT 5 IMT 6 IMT 7 IMT 8 Plaque Plaq 1 Plaq 2 To calculate IMT automatically 1 Onafrozen2Dimage,presstheCALCSkey. 2 Fromthecalculationsmenu,selectthe measurement. 3 Usingthetouchpadorarrowkeys,position theIMTtoolovertheareaofinterestuntilthe measurementresultsappear. 4 Adjustthetool,andeditasneeded.SeeIMT tooloptionsonpage 60. 5 Savethecalculation.(SeeTosavea calculationonpage 45.) IMT tool options WhenusingtheIMTtool,youcanselectthe followingoptionsonscreen. Option Description Hide Move Width Edit Smooth Adven Lumen Use to check results. Hides the measurement results and trace line. Select Show to redisplay them. Repositions the tool horizontally by several pixels. The upper key moves the tool right, and the lower key moves the tool left. Adjusts the tool width by 1 mm. The upper key increases the width, and the lower key decreases the width. Displays Smooth, Adven, and Lumen. Adjusts the IMT line smoothing. Select Edit to display this option. Adjusts the adventitia-media line. The upper key moves the line upward. The lower key moves the line downward. Select Edit to display this option. Adjusts the lumen-intima line. The upper key moves the line upward. The lower key moves the line downward. Each of the two IMT lines can be adjusted independently. Select Edit to display this option. 60 Exam-based calculations To trace IMT manually InmanuallytracingIMT,theuserdefinesthe location. 1 Onafrozen2Dimage,presstheCALCSkey 2 Fromthecalculationsmenu,selecta measurementname. 3 SelectEditonscreen,andthenselectManual, andthenselectSketch. Asinglecaliperappears,andTraceappears nexttothemeasurement. 4 Dothefollowingforthedesired adventitiamediaboundaryandthenforthe lumenintimaboundary:

a Positionthecaliperatthebeginningofthe boundary,andpresstheSELECTkey. b Usingthetouchpad,markpointsby movingthecalipertothenextdesired pointandpressingtheSELECTkey. Tomakeacorrection,selectUndo onscreenorpresstheBACKSPACEkeyto deletethelastsegment. c PresstheSETkeytocompletethetraceline. 5 Savethecalculation.(SeeTosavea calculationonpage 45.) To sketch IMT TheIMTsketchmeasurementinvolvestwo userdefinedsketchlinesthatyoucanadjust manually. 1 Onafrozen2Dimage,presstheCALCSkey 2 Fromthecalculationsmenu,selecta measurementname. 3 SelectEditonscreen,andthenselectManual. Asinglecaliperappearsonscreen,andSketch appearsnexttothemeasurement. 4 Dothefollowingforthedesired adventitiamediaboundaryandthenforthe lumenintimaboundary:

a Positionthecaliperatthebeginningofthe boundaryandpresstheSELECTkey. b Usingthetouchpad,markpointsby movingthecalipertothenextdesired pointandpressingtheSELECTkey. Tomakeacorrection,selectUndo onscreenorpresstheBACKSPACEkeyto deletethelastsegment. c PresstheSETkeytocompletethetraceline. d Ifnecessary,adjustoreditthe measurement.SeeIMTtooloptionson page 60. e Savethecalculation.(SeeTosavea calculationonpage 45.) OB calculations EFWiscalculatedonlyafterappropriate measurementsarecompleted.Ifanyoneofthese parametersresultsinanEDDgreaterthanwhat theOBcalculationtablesprovide,theEFWisnot displayed. WARNING: Make sure that you have selected the OB exam type and the OB author for the OB calculation table you intend to use. See Results from System-Defined OB Measurements and Table Authors on page 62. To avoid incorrect obstetrics calculations, verify with a local clock and calendar that the systems date and time settings are correct before each use of the system. The system does not automatically adjust for daylight savings time changes. M e a s u r e m e n t s Chapter 4: Measurements and Calculations 61 To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. Prior to use, verify that OB custom table data entries are correct. The system does not confirm the accuracy of the custom table data entered by the user. Transducer Exam Type C60x ICTx P21x OB OB OB Ifyouchangethecalculationauthorduringthe exam,thecommonmeasurementsareretained. Thefollowingtableshowsthesystemdefined measurementsavailableforOBcalculationsby author.Fordefinitionoftheacronyms,see Glossaryonpage 157.Toselectauthors,see OBCalculationssetuponpage 20. SeealsoOBCustomMeasurementssetupon page 21andOBCustomTablessetupon page 22. Results from System-Defined OB Measurements and Table Authors Calculation Result Gestational OB Measurements Table Authors Gestational Agea YS GS CRL BPD OFD HC TTD APTD AC FTA FL CX L Hansmann, Nyberg, Tokyo U. Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann, Osaka, Tokyo U. Hansmann Chitty, Hadlock, Hansmann Hansmann, Tokyo U.b Tokyo U.b Hadlock, Hansmann, Tokyo U. Osaka Chitty, Hadlock, Hansmann, Osaka, Tokyo U. 62 Exam-based calculations Calculation Result Gestational OB Measurements Table Authors Estimated Fetal Weight (EFW)c HC, AC, FL BPD, AC, FL AC, FL BPD, TTD BPD, FTA, FL BPD, AC Hadlock 1 Hadlock 2 Hadlock 3 Hansmann Osaka U. Shepard BPD, TTD, APTD, FL Tokyo U. Ratios HC/AC FL/AC FL/BPD FL/HC Amniotic Fluid Index Q1, Q2, Q3, Q4 Growth Analysis Tablesd BPD HC AC FL EFW HC/AC Campbell Hadlock Hohler Hadlock Jeng Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Hadlock, Jeanty Campbell a. The Gestational Age is automatically calculated and displayed next to the OB measurement you selected. The average of the results is the AUA. b. For Tokyo U., APTD and TTD are used only to calculate EFW. No age or growth tables are associated with these measurements. c. The Estimated Fetal Weight calculation uses an equation that consists of one or more fetal biometry measurements. The author for the OB tables, which you choose on a system setup page, determines the measurements you must perform to obtain an EFW calculation. (See OB Calculations setup on page 20.) Individual selections for Hadlocks EFW equations 1, 2, and 3 are not determined by the user. The selected equation is determined by the measurements that have been saved to the patient report with priority given to the order listed above. d. The Growth Analysis tables are used by the Report Graphs feature. Three growth curves are drawn using the table data for the selected growth parameter and published author. Growth tables are only available with a user-entered LMP or Estab. DD. To measure gestational growth (2D) Foreach2DOBmeasurement(exceptAFI),the systemsavesuptothreeindividual measurementsandtheiraverage.Ifyoutake morethanthreemeasurements,theearliest measurementisdeleted. 1 Inthepatientinformationform,selectOB examtype,andselectLMPorEstab.DD.Select Twinsifappropriate. 2 Onafrozen2Dimage,presstheCALCSkey. 3 Dothefollowingforeachmeasurementyou wanttotake:

a Fromthecalculationsmenu,selectthe measurementname.Fortwins,select Twin AorTwin B,andthenselectthe measurementname. Thecalipertoolmaychangedependingon themeasurementselected,buttheposition remainsconstant. b Positionthecalipers.(SeeWorkingwith calipersonpage 41.) c Savethecalculation.(SeeTosavea calculationonpage 45.) To measure fetal heart rate (M Mode) 1 OnafrozenM Modetrace,presstheCALCS key. 2 SelectFHRfromthecalculationsmenu. Averticalcaliperappears. Chapter 4: Measurements and Calculations 63 M e a s u r e m e n t s 3 Usingthetouchpad,positionthevertical caliperatthepeakoftheheartbeat. CerebralArtery)orUmbA(Umbilical Artery). 4 PresstheSELECTkey. b Positionthecalipers:

Asecondverticalcaliperappears. 5 Usingthetouchpad,positionthesecond verticalcaliperatthepeakofthenext heartbeat. 6 Savethecalculation.(SeeTosavea calculationonpage 45.) OB Doppler Calculations Menu Heading MCA (Middle Cerebral Artery) Umb A

(Umbilical Artery) OB Calculation S/D, RI S/D, RI, PI*

S/D, RI S/D, RI, PI*

Results SD RI SD RI PI SD RI SD RI PI

*Calculation requires a trace measurement. To calculate MCA or Umba (Doppler) Note: ThesystemdoesnotprovideanMCA/UmbA ratiofromthePI(PulsatilityIndex). 1 Select OBexamtype,andselectLMPor Estab.DDinthepatientinformationform. 2 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 3 Dothefollowingforeachmeasurementyou needtotake:

a Fromthecalculationsmenu,selectthe measurementnameunderMCA(Middle ForS/D, RI,positionthefirstcaliperat thepeaksystolicwaveform.Pressthe SELECTkey,andpositionthesecond caliperattheenddiastoleonthe waveform. ForS/D, RI, PI,positionthecaliperat thebeginningofthedesiredwaveform, andpresstheSELECTkey.Usethe touchpadtomanuallytracethedesired area.PresstheSETkey. Ifcalipersarenotpositionedcorrectly, thecalculationresultisinaccurate. c Savethecalculation.(SeeTosavea calculationonpage 45.) Onlyonecalculation(S/D, RIorS/D, RI, PI) canbesaved. Small Parts calculations SmallPartscalculationsincludevolume,hip angle,andd:Dratio.Forinstructionstocalculate volume,seeVolumecalculationsonpage 48. Transducer Exam Type HFL38x L38x Small Parts Small Parts To calculate hip angle 1 Onafrozen2Dimage,presstheCALCSkey. 2 Fromthecalculationsmenu,selectRightor Left. 3 SelectBaselineunderHip Angle. Abaselineappearsonscreen. 4 Positionthebaseline,andpresstheSETkey.

(SeeWorkingwithcalipersonpage 41.) LineA(alphaline)appearsonscreen,and Line Aisselectedinthecalculationsmenu. 64 Exam-based calculations 5 PositionLineA,andsavethemeasurement.

(SeeTosaveacalculationonpage 45.) LineB(betaline)appearsonscreen,andLine Bisselectedinthecalculationsmenu. 6 PositionLineB,andsavethemeasurement. To calculate d:D ratio 1 Onafrozen2Dimage,presstheCALCSkey. 2 Fromthecalculationsmenu,selectRightor Left. 3 Underd:D Ratio,selectFem Hd(femoral head). 4 Usingthetouchpad,positionandresizethe circle.TheSELECTkeytogglesbetween positionandsize. 5 PresstheSETkey. Thebaselineautomaticallyappearswiththe leftcaliperactive. 6 Positionthecaliper.(SeeWorkingwith calipersonpage 41.) 7 Savethemeasurement.(SeeTosavea calculationonpage 45.) Transcranial Doppler and Orbital calculations WARNING:

To avoid injury to the patient, use only an Orbital (Orb) exam type when performing imaging through the eye. Verify that the patient information, date, and time settings are accurate. To avoid carrying over measurements from the previous patient, start a new patient information form for each new patient before you perform calculations on the new patient. See To create a new patient information form on page 34. Transducer Exam Types P21x Transcranial (TCD), Orbital

(Orb) Thefollowingtableshowsthemeasurements requiredtocompleteTranscranialDoppler(TCD) andOrbital(Orb)calculations.Fordefinitionsof acronyms,seeGlossaryonpage 157. M e a s u r e m e n t s Chapter 4: Measurements and Calculations 65 Transcranial and Orbital Calculations Menu Heading TCD and Orb Measurements TT MCA TT TO Dist Mid Prox Bifur*

ACA ACoA*

TICA PCAp1 PCAp2 PCoA OA Siphon SM ECICA Results TAP PSV EDV PI RI S/D Gate Size TAP PSV EDV PI RI S/D Gate Size TAP PSV EDV PI RI S/D Gate Size Transcranial and Orbital Calculations Menu Heading TCD and Orb Measurements FM FM BA VA Prox Mid Dist AL ECVA Results TAP PSV EDV PI RI S/D Gate Size TAP PSV EDV PI RI S/D Gate Size

*Available but not required WARNING:

To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orbital or Ophthalmic exam type is selected. To perform a Transcranial Doppler or Orbital calculation 1 Selectthecorrectexamtype:

Orbital (Orb)tomeasureOpthalmicArtery andSiphon Transcranial (TCD)forothermeasurements SeeTochangetheexamtypeonpage 31. 66 Exam-based calculations 2 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 3 Fromthecalculationsmenu,selectLeftor Right. 4 Dothefollowingforeachmeasurementyou wanttotake:

a Fromthecalculationsmenu,selectthe measurement.(Youmayneedtoselect NextorPrevtolocatethemeasurement.) b Dooneofthefollowing:

Foramanualtracemeasurement,usethe touchpadtopositionthecaliper.Pressthe SELECTkey.Usethetouchpadtotracethe waveform. Ifyouneedtomakeacorrection,select UndoonscreenorpresstheBACKSPACE key. Foranautotracemeasurement,select Autoonscreen,andusethetouchpadto positionthefirstcaliperatthebeginning ofthewaveform.PresstheSELECTkey,and positionthesecondcaliperattheendof thewaveform. Confirmthatthesystemgenerated boundaryiscorrect.Ifyouarenotsatisfied withthetrace,obtainahigherquality Dopplerspectraltraceimage,ortrace manually. c PresstheSETkey. d Savethecalculation.(SeeTosavea calculationonpage 45.) Vascular calculations WARNING:

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patients data. The previous patients data will be combined with the current patient if the form is not first cleared. See To create a new patient information form on page 34. To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. Transducer Exam Type C11x HFL38x L25x L38x SLAx Vascular Vascular Vascular Vascular Vascular Thevascularmeasurementsthatyoucansaveto thepatientreportarelistedinthefollowingtable. Fordefinitionsofacronyms,seeGlossaryon page 157 M e a s u r e m e n t s Chapter 4: Measurements and Calculations 67

. Vascular Calculations Menu Heading Vascular Measurement Calculation Results CCA Prox Mid Dist Bulb Prox Mid Dist ICA ECA Prox Mid Dist VArty s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) s (systolic), d (diastolic) To perform a Vascular calculation Afteryouperformvascularmeasurements, valuesintheICA/CCAratiosareselectableonthe vascularpageofthepatientreport. 1 OnafrozenDopplerspectraltrace,pressthe CALCSkey. 2 Fromthecalculationsmenu,selectLeftor Right. 3 Dothefollowingforeachmeasurementyou wanttotake:

a Fromthecalculationsmenu,selectthe measurementname. b Usingthetouchpad,positionthecaliperat thepeaksystolicwaveform. c PresstheSELECTkey. Asecondcaliperappears. d Usingthetouchpad,positionthesecond caliperattheenddiastoleonthe waveform. e Savethecalculation.(SeeTosavea calculationonpage 45.) Patient report Thepatientreportcontainscalculationresults andpatientinformation.ForCardiac,OB, Transcranial,andVascularexams,thepatient reporthasadditionaldetailsandfeatures. Youcandisplaythepatientreportatanytime duringtheexam. Thevalueforacalculationappearsonlyifthe calculationisperformed.Thepoundsymbol(###) indicatesavaluethatisoutofrange(forexample, toolargeorsmall).Calculationvaluesthatareout ofrangearenotincludedinderivedcalculations

(forexample,mean). To display a patient report 1 PresstheREPORTkey. 2 Doanyofthefollowing:

Todisplayadditionalpages,select onscreen. 1/x

(Cardiac,Vascular,orTCD)SelectDetails orSummaryonscreen.Themeanofthe detailentriesisusedinthesummary. 3 (Optional)PresstheSAVEkeytosavethe currentpageofthepatientreport. 68 Patient report Toexitthepatientreportandreturntoimaging, selectDone. To send a patient report to a PC YoucansendapatientreporttoaPCasatextfile. 1 Ensurecorrectconfiguration.SeeTo configurethesystemforaDVDrecorder,PC, orserialbarcodescanneronpage 19. Makesuretousetheconnectioncable suppliedbySonoSite.Otherconnectioncables maycauseaudiointerference,includingan inaudibleDopplersignal. 2 SelectSend Rep.onscreen. Vascular and cardiac patient reports To delete a vascular or cardiac measurement 1 OntheDetailspageofthepatientreport, selectthemeasurementbyusingthe touchpad.(Theselectedmeasurementis green.) 2 SelectDeleteonscreen. Deletingsomemeasurementsalsodeletes relatedmeasurements.Deleted measurementsarenotincludedinthe summaryinformation.

(Vascular) To modify the ICA/CCA ratio

IntheRatiolistinthevascularpatientreport, selectmeasurementsfortheICA/CCAratio forboththerightandleftsides.

(Cardiac) To adjust the RA pressure

OntheSummarypageofthecardiacpatient report,selectfromtheRAlist. ChangingtheRApressurefromthedefault5 affectstheRVSPcalculationresult. TCD patient report ThemaximumvaluesfortheTAPcalculation appearonthesummarypage. To delete a row of TCD measurements 1 OntheDetailspageoftheTCDpatientreport, selecttherowsTAPmeasurementusingthe touchpad.(Theselectedmeasurementis green.) 2 SelectDeleteonscreen. Deletedmeasurementsarenotincludedinthe summaryinformation. OB patient report TheOBpatientreportpageshaveaspacefor signingprintedreports. To display the OB Twins patient report

OntheOBpatientreport,selectoneofthe followingonscreen:

Twin A/Bforindividualtwinpatient reports Compareforbothtwinsinonepatient report To delete an OB measurement 1 OntheOBpatientreport,selecttheOB measurementbyusingthetouchpad. Theselectedmeasurementisgreen. 2 SelectDeleteonscreen. Todeleteallmeasurements,selectthe measurementlabelandpresstheSELECTkey andthenselectDeleteonscreen. M e a s u r e m e n t s Chapter 4: Measurements and Calculations 69 measurement/authororselect onscreen. Fortwins,bothmeasurementsetsareplotted onthesamegraph. 1/x 3 (Optional)PresstheSAVEkeytosavethe currentgraphpage. 4 Selectoneofthefollowingonscreen:

Reporttoreturntothepreviouspatient reportpage Donetoreturntoliveimaging. EMED worksheets EMEDworksheetscontainresultsfromEMED calculationsandcheckliststhatyoucancomplete. To display an EMED worksheet Thisfeatureisoptional. 1 Afterorduringtheexam,presstheREPORT key. 2 SelectEMEDonscreen. 3 SelecttheworksheetfromtheWorksheetlist orbyselecting x/xonscreen. Figure 3 OB Anatomy Checklist Page To fill out the OB anatomy checklist Youcandocumentreviewedanatomy.

OntheAnatomy ChecklistpageintheOB patientreport,selectthecheckboxes. PresstheTABkeytomovebetweenfieldsand theSPACEBARtoselectanddeselectitemsin thechecklist. To complete the OB biophysical profile

Onpage2oftheOBpatientreport,select valuesunderBPP. Thetotaliscalculatedwhenvaluesare selected.NST(nonstresstest)isoptional. To display OB graphs YoucandisplayOBgraphsiftheLMPorEstab. DDfieldsarecompleteinthepatientinformation form. 1 OntheOBpatientreport,selectGraphs onscreen. 2 IntheGraphslist,selectthedesired measurement/author. Thegraphfortheselectedmeasurement appears.Youcanselectanother 70 Patient report Chapter 5: Troubleshooting and Maintenance Thischaptercontainsinformationtohelpcorrect problemswithsystemoperation,toentera softwarelicense,andtotakepropercareofthe system,transducer,andaccessories. Troubleshooting Ifyouencounterdifficultywiththesystem,use thefollowinglisttohelptroubleshootthe problem.Iftheproblempersists,contactSonoSite TechnicalSupport.(SeeSonoSiteTechnical Supportonpage vii.) System does not turn on.Checkallpower connections. RemovetheDCinputconnectorandbattery,wait 10seconds,andthenreinstallthem. Ensurethatthebatteryischarged. System image quality is poor.Adjustthedisplay toimproveviewingangle. Adjustthebrightness. Adjustthegain. No CPD image.Adjustthegain. No Color image.AdjustthegainorthePRFscale. NoOBmeasurementselections. SelecttheOBexamtype. Print does not work.Selecttheprinteronthe Connectivitysetuppage.SeeToconfigurethe systemforaprinteronpage 19. Checktheprinterconnections. Ensurethattheprinteristurnedonandsetup properly.Seetheprintermanufacturers instructions,ifnecessary. DVD recorder does not record.ChecktheDVD recorderconnections. EnsurethattheDVDrecorderisturnedonand setupproperly.SeetheapplicableSonoSite accessoryuserguideandthemanufacturers instructions. Externalmonitordoesnotwork. Checkthemonitorconnections. Checkthemonitortoensurethatitisturnedon andsetupproperly.Seethemonitor manufacturersinstructions,ifnecessary. System does not recognize the transducer. Disconnectandreconnectthetransducer. appears on the system A maintenance icon screen.Systemmaintenancemayberequired. RecordthenumberinparenthesesontheC:line andcontactSonoSiteoryourSonoSite representative. Software licensing SonoSitesoftwareiscontrolledbyalicensekey. Afteryouinstallnewsoftware,thesystem promptsyouforalicensekey.Youmustobtain onekeyforeachsystemortransducerthatuses thesoftware. Thesoftwarewilloperateforashorttime(the graceperiod)withoutalicensekey.Duringthe graceperiod,allsystemfunctionsareavailable. Afterthegraceperiod,thesystemisnotusable untilyouenteravalidlicensekey.Graceperiod timeisnotusedwhilethesystemisofforasleep. Graceperiodtimeremainingappearsonthe licenseupdatescreen. Caution:

After the grace period expires, all system functions except licensing are unavailable until a valid license key is entered. Chapter 5: Troubleshooting and Maintenance 71 T r o u b l e s h o o t i n g Toobtainalicensekeyforyoursoftware,contact SonoSiteTechnicalSupport.(SeeSonoSite TechnicalSupportonpage vii.)Youneedto providethefollowinginformation.(SeeSystem Informationsetuponpage 23.) System Software Transducer Software Name of person installing the upgrade Serial number (on bottom of system) ARM version PCBA serial number Name of person installing the upgrade Transducer serial number Transducer part number

(REF) or model number (for example, C60x) Transducer bundle version Afteryouobtainalicensekey,youmustenterit intothesystem. To enter a license key 1 Turnonthesystem. Thelicenseupdatescreenappears. 2 EnterthelicensekeyintheEnter license numberfield. 3 SelectDoneonscreen. Ifyouenteredavalidlicensekeybutthe licenseupdatescreenappears,verifythatyou enteredthelicensekeycorrectly.Ifthelicense updatescreenstillappears,contactSonoSite TechnicalSupport.(SeeSonoSiteTechnical Supportonpage vii.) Maintenance Usetherecommendationsinthissectionwhen cleaningordisinfectingyourultrasoundsystem, transducer,andaccessories.Usethecleaning recommendationsintheperipheral manufacturersinstructionswhencleaningor disinfectingyourperipherals. Noperiodicorpreventivemaintenanceis requiredforthesystem,transducer,or accessoriesotherthancleaninganddisinfecting thetransduceraftereveryuse.(SeeCleaning anddisinfectingtransducersonpage 74.)There arenointernalcomponentsthatrequireperiodic testingorcalibration.Allmaintenance requirementsaredescribedinthischapterandin theultrasoundsystemservicemanual. Performingmaintenanceproceduresnot describedintheuserguideorservicemanual mayvoidtheproductwarranty. ContactSonoSiteTechnicalSupportforany maintenancequestions.(SeeSonoSiteTechnical Supportonpage vii.) WARNING:

Disinfectants and cleaning methods listed are recommended by SonoSite for compatibility with product materials, not for biological effectiveness. Refer to the disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses. The level of disinfection required for a device is dictated by the type of tissue it contacts during use. To avoid infection, ensure that the disinfectant type and the solution strength and duration are appropriate for the equipment. For information, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology

(APIC) and the FDA. 72 Maintenance Caution:

WARNING:

To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure. Caution:

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. Cleaning and disinfecting the ultrasound system Theexteriorsurfaceoftheultrasoundsystemand theaccessoriescanbecleanedanddisinfected usingarecommendedcleanerordisinfectant.See Recommendeddisinfectantsonpage 77. WARNING:

To avoid electrical shock, before cleaning, disconnect the system from the power supply or remove from the mini-dock or docking system. To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures. To avoid infection, ensure that the solution expiration date has not passed. Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may cause solution to leak into the system, damaging the system and voiding the warranty. Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since these will damage the exterior surfaces. Use only recommended cleaners or disinfectants on system surfaces. Immersion-type disinfectants are not approved for use on system surfaces. When you clean the system, ensure that the solution does not get inside the system controls or the battery compartment. Do not scratch the LCD screen. To clean the LCD screen

Dampenaclean,nonabrasive,cottoncloth withanethanolicbasedcleaner,andwipethe screenclean. Applythecleanertotheclothratherthanthe surfaceofthescreen. To clean and disinfect system surfaces 1 Turnoffthesystem. 2 Disconnectthesystemfromthepowersupply, orremoveitfromtheminidockordocking system. 3 Cleantheexteriorsurfacesusingasoftcloth lightlydampenedinamildsoapordetergent cleaningsolutiontoremoveanyparticulate matterorbodyfluids. Applythesolutiontotheclothratherthanthe surface. 4 Mixthedisinfectantsolutioncompatiblewith thesystem,followingdisinfectantlabel Chapter 5: Troubleshooting and Maintenance 73 T r o u b l e s h o o t i n g instructionsforsolutionstrengthsand disinfectantcontactduration. 5 Wipesurfaceswiththedisinfectantsolution. 6 Airdryortoweldrywithacleancloth. Cleaning and disinfecting transducers Todisinfectthetransduceranditscable,usethe immersionmethodorthewipemethod. Immersibletransducerscanbedisinfectedonlyif theproductlabelingindicatestheycanbeused withanimmersionmethod. SeeTable 1,DisinfectantCompatibilitywith SystemandTransducersonpage 77. WARNING:

Caution:

To avoid electrical shock, before cleaning, disconnect the transducer from the system. To avoid injury, always use protective eyewear and gloves when performing cleaning and disinfecting procedures. To avoid infection, ensure that the solution expiration date has not passed. Transducers must be cleaned after every use. Cleaning transducers is necessary prior to effective disinfection. Ensure that you follow the manufacturer's instructions when using disinfectants. Do not use a surgeon's brush when cleaning transducers. Even the use of soft brushes can damage a transducer. Use a soft cloth. Using a non-recommended cleaning or disinfection solution, incorrect solution strength, or immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty. Do not allow cleaning solution or disinfectant into the transducer connector. Do not allow disinfectant to contact metal surfaces. Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces. Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty. To clean and disinfect a transducer (wipe method) 1 Disconnectthetransducerfromthesystem. 2 Removeanytransducersheath. 3 Cleanthesurfaceusingasoftclothlightly dampenedinamildsoapordetergent cleaningsolutiontoremoveanyparticulate matterorbodyfluids. Applythesolutiontotheclothratherthanthe surface. 4 Rinsewithwaterorwipewith waterdampenedcloth;thenwipewithadry cloth. 5 Mixthedisinfectantsolutioncompatiblewith thetransducer,followingdisinfectantlabel instructionsforsolutionstrengthsand disinfectantcontactduration. 6 Wipesurfaceswiththedisinfectantsolution. 74 Maintenance 7 Airdry. 8 Examinethetransducerandcablefordamage suchascracks,splitting,orfluidleaks. Ifdamageisevident,discontinueuseofthe transducer,andcontactSonoSiteoryourlocal representative. To clean and disinfect a transducer

(immersion method) 1 Disconnectthetransducerfromthesystem. 2 Removeanytransducersheath. 3 Cleanthesurfaceusingasoftclothlightly dampenedinamildsoaporcompatible cleaningsolutiontoremoveanyparticulate matterorbodyfluids. Applythesolutiontotheclothratherthanthe surface. 4 Rinsewithwaterorwipewith waterdampenedcloth,andthenwipewitha drycloth. 5 Mixthedisinfectantsolutioncompatiblewith thetransducer,followingdisinfectantlabel instructionsforsolutionstrengthsand disinfectantcontactduration. 6 Immersethetransducerintothedisinfection solutionnotmorethan1218 inches

(3146 cm)fromthepointwherethecable enterstheconnector. Followtheinstructionsonthedisinfectant labelforthedurationofthetransducer immersion. 7 Usingtheinstructionsonthedisinfectant label,rinsetothepointoftheprevious immersion,andthenairdryortoweldrywith acleancloth. 8 Examinethetransducerandcablefordamage suchascracks,splitting,orfluidleaks. Ifdamageisevident,discontinueuseofthe transducer,andcontactSonoSiteoryourlocal representative. Cleaning and disinfecting the battery Caution:

To avoid damaging the battery, do not allow cleaning solution or disinfectant to come in contact with the battery terminals. To clean and disinfect a battery (wipe method) 1 Removethebatteryfromthesystem. 2 Cleanthesurfaceusingasoftclothlightly dampenedinamildsoapordetergent cleaningsolution. Applythesolutiontotheclothratherthanthe surface. 3 Wipethesurfaceswiththedisinfection solution.SaniClothHB,SaniClothWipes,or 70%isopropylalcoholisrecommended. 4 Airdr. Cleaning the footswitch Caution:

To avoid damaging the footswitch, do not sterilize. It is not intended for use in a sterile environment. To clean the footswitch 1 Dampenanonabrasiveclothwithoneofthe followingproducts:

Isopropylalcohol Soapandwater Cidex SodiumHypochlorite5.25%(Bleach) diluted10:1 2 Wringoutclothuntilslightlywetandthen gentlyrubsoiledareauntilclean. T r o u b l e s h o o t i n g Chapter 5: Troubleshooting and Maintenance 75 Cleaning and disinfecting ECG cables Caution:

To avoid damaging the ECG cable, do not sterilize. To clean and disinfect the ECG cable (wipe method) 1 Removethecablefromthesystem. 2 Cleanthesurfaceusingasoftclothlightly dampenedinamildsoapordetergent cleaningsolution. Applythesolutiontotheclothratherthanthe surface. 3 Wipethesurfaceswithanyofthefollowing products:

Bleach(sodiumhypochlorite) Cidexdisinfectants Greensoap 4 Airdryortoweldrywithacleancloth. 76 Maintenance Recommended disinfectants Table 1 does not have the following regulatory information for disinfectants:

EPA Registration FDA 510(k) clearance (liquid sterilant, high level disinfectant) CE approval Before using a disinfectant, confirm that its regulatory status is appropriate for your jurisdiction and use. Verify expiration dates on chemicals. When disposing of chemicals, follow manufacturer recommendations and EPA regulations. Seewww.sonosite.comforupdatedcleaninganddisinfectantinformation. Table 1: Disinfectant Compatibility with System and Transducers Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient AbcoCide 14 Accel Plus Accel TB Accel Wipes Aidal Plus Alkacide Alkazyme Anioxyde 1000 Aquatabs (1000) USA CAN CAN CAN AUS FRA FRA FRA IRL Liquid Gluteraldehyde Wipe Wipe Wipe Hydrogen Peroxide Hydrogen Peroxide Hydrogen Peroxide Liquid Gluteraldehyde Liquid Gluteraldehyde Liquid Quat. Ammonia Liquid Peracetic Acid Tablet Sodium Dichloroisocyanurate Troubleshooting C60x ICTx L38x P10x P21x SLAx A N N A A A A N A D2x HFL38x C11x/

L25x System Surfaces A N N A A A A N N A N N A A A A N A U U U U U U U U U C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 7 7 7 8 Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient Aquatabs (2000) IRL Tablet Aquatabs (5000) IRL Tablet Sodium Dichloroisocyanurate Sodium Dichloroisocyanurate Ascend Asepti-HB Asepti-Steryl Asepti-Wipes Bacillocid rasant Bacoban Bacoban WB Banicide Betadine Bleach Cavicide Caviwipes Chlor-Clean USA USA USA USA DEU DEU DEU USA USA USA USA USA GBR Liquid Quat Ammonia Liquid Quat Ammonia Spray Wipe Ethanol Propanol (Isopropyl Alcohol Liquid Glut./Quat. Ammonia Liquid Ethanol Isopropanol Liquid Benzalkoniumchloride Diethylenglycol Liquid Gluteraldehyde Liquid Providone-Iodine Liquid NaCl Hypochlorite Liquid Isopropyl Wipes Isopropanol Liquid Sodium Dichloroisocyanurate C60x ICTx L38x P10x P21x SLAx A N A A A A A A A A N A A A A D2x HFL38x C11x/

L25x System Surfaces U U U U U U U A A U U U U U U N N A A A A A U U U N A A A N A N A A A A A U U A A A A N A U U U U U A U U U U U U U A U Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient Cidalkan FRA Liquid Alkylamine, isopropanol Cidalkan Lingettes FRA Wipes Ethyl Alcohol Cidex Cidex OPA Cidex Plus Cleanisept Clorox Wipes Control III Coverage Spray USA USA USA DEU USA USA USA Liquid Gluteraldehyde Liquid Ortho-phthaldehyde Liquid Gluteraldehyde Wipes Wipes Quat. Ammonia Isopropanol Liquid Quat. Ammonia Spray Quat. Ammonia Denatured Alcohol USA Liquid Ethanol DentaSept DisCide Ultra Disinfecting Towelettes DisCide Wipes DisOPA Dispatch Dynacide PA FRA USA USA JPN USA FRA Liquid Quat. Ammonia Wipes Isopropyl Alcohol Wipes Isopropyl Alcohol Liquid Ortho-phthaldehyde Spray NaCl Hypochlorite Liquid Peracetic Acid C60x ICTx L38x P10x P21x SLAx U U A A A A A A A N N U A A A U D2x HFL38x C11x/

L25x System Surfaces N N U A U A U U U U U U U A A A U U A A A A A A A N N U A A A U U U A A A A A N N N N U A A A U U U A U A A U U N U U N N A U U C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 7 9 Troubleshooting 8 0 Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient End-Bac II USA Liquid Quat. Ammonia Endozime AW Plus FRA Liquid Propanol Envirocide Enzol Expose Gigasept AF Gigasept FF USA USA USA DEU DEU Liquid Isopropyl Cleaner Ethylene Glycol Liquid Isopropyl Liquid Quat. Ammonia Liquid Bersteinsaure Gluteraldehyde SDS USA Liquid Gluteraldehyde Hexanios FRA Liquid Polyhexanide/Quat. Ammonia Hi Tor Plus Hibiclens USA USA Liquid Chloride Cleaner Chlorhexidine Hydrogen Peroxide USA Liquid Hydrogen Peroxide Isopropanol Alcohol ALL Liquid Alcohol Kodan Tcher Kohrsolin ff Korsolex basic Lem-O-Quat DEU DEU DEU USA Liquid Propanol Liquid Gluteraldehyde Liquid Gluteraldehyde Liquid Alkyl/Chloride C60x ICTx L38x P10x P21x SLAx A A A A A A N A A A A A N A A N U D2x HFL38x C11x/

L25x System Surfaces U U U U U U U U U U U A U U U U A A A U A A A N U A A A A N A U N U A A N A A A N A A N A A N A A N U A U U U U U U U U U U A U N U U U Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient LpHse Lysol Lysol IC Madacide 1 Matar MetriCide 14 MetriCide 28 MetriZyme Mikrobak forte Mikrozid Wipes Nuclean Precise Ruthless Sagrosept Wipe Salvanios pH 7 Sani-Cloth HB Sani-Cloth Plus C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 8 1 Sekusept USA USA USA USA USA USA USA USA DEU DEU FRA USA USA DEU FRA USA USA DEU Liquid O-phenylphenol Spray Ethanol Liquid O-phenylphenol Liquid Isopropanol Liquid O-phenylphenol Liquid Gluteraldehyde Liquid Gluteraldehyde Cleaner Propylene Glycol Liquid Ammonium Chloride Wipe Spray Spray Spray Wipe Ethanol/Propanol Alcohol/Biguanide O-phenylphenol Quat. Ammonia Propanol Liquid Quat. Ammonia Wipe Wipe Quat. Ammonia Quat. Ammonia Liquid Gluteraldehyde Troubleshooting C60x ICTx L38x P10x P21x SLAx A N A A A A A A A A A N A A A A A U D2x HFL38x C11x/

L25x System Surfaces U U U N U U U U U U U U U U U U U A A N N A U A A A A A A N A A A A A U A N A N A A A A A A A N N A A N A U U U U N U U U U U N U U U U U A A U 8 2 Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient Sklar Sporicidin Sporicidin Wipes Staphene Steranios Super Sani-Cloth T-Spray T-Spray II TASK 105 TBQ Theracide Plus Wipes Tor Transeptic Tristel Tristel Duo Tristel Solo Tristel Wipes USA USA USA USA FRA USA USA USA USA USA USA USA USA GBR GBR GBR GBR Liquid Isopropanol Liquid Phenol Wipe Spray Phenol Ethanol Liquid Gluteraldehyde Wipe Spray Spray Spray Isopropyl Alcohol Quat. Ammonia Alkyl/Chloride Quat. Ammonia Liquid Alkyl Wipe Quat. Ammonia Liquid Quat. Ammonia Cleaner Alcohol Liquid Chlorine Dioxide Foam Wipe Hexamethylenebiguanide Chlorine Dioxide C60x ICTx L38x P10x P21x SLAx A A A A A N A A A A A A N A U U N D2x HFL38x C11x/

L25x System Surfaces U N U U U U U U U U U U U A U A A A A A N A N A A A A A A N A U U N N A A A A N N A A A A N N A U U N U U N N U N N U U U A U U U U U A Table 1: Disinfectant Compatibility with System and Transducers (continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient Vesphene II USA Liquid Sodium/

o-Phenylphenate Virex II 256 Virex TB Virox 5 Virufen Wavicide -01 Wavicide -06 Wet Wipe Disinfection USA USA CAN FRA USA USA DNK Liquid Ammonium Chloride Liquid Quat. Ammonia Wipe Hydrogen Peroxide Liquid Alkyl Ammonium Chloride Liquid Gluteraldehyde Liquid Gluteraldehyde Wipe Guanidinium-chloride Wex-Cide USA Liquid O-phenylphenol A = Acceptable N = No (Do not use) U = Untested (Do not use) C60x ICTx L38x P10x P21x SLAx A A A A U N A U A D2x HFL38x C11x/

L25x System Surfaces U U U A A U U A U A A A A U N A U A A A N A U N A U A U U N A U U U U U C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 8 3 Troubleshooting 84 Chapter 6: Safety Thischaptercontainsinformationrequiredbyregulatoryagencies,includinginformation abouttheALARA(aslowasreasonablyachievable)principle,theoutputdisplaystandard, acousticpowerandintensitytables,andothersafetyinformation.Theinformationappliesto theultrasoundsystem,transducer,accessories,andperipherals. S a f e t y Ergonomic safety Thesehealthyscanningguidelinesareintendedtoassistyouinthecomfortandeffectiveuse ofyourultrasoundsystem. WARNING:

To prevent musculoskeletal disorders, follow the guidelines in this section. Use of an ultrasound system may be linked to musculoskeletal disorders (MSDs)a,b,c. Use of an ultrasound system is defined as the physical interaction between the operator, the ultrasound system, and the transducer. When using an ultrasound system, as with many similar physical activities, you may experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back, or other parts of your body. However, if you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified health professional. Symptoms such as these can be linked with MSDs. MSDs can be painful and may result in potentially disabling injuries to the nerves, muscles, tendons, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and tendonitis. While researchers are not able to definitively answer many questions about MSDs, there is a general agreement that certain factors are associated with their occurrence including preexisting medical and physical conditions, overall health, equipment and body position while doing work, frequency of work, duration of work, and other physical activities that may facilitate the onset of MSDsd. This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDse,f. a.Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. Work-related Musculoskeletal Complaints in Sonologists. Occupational Environmental Medicine. 41:11 (1999), 981-988. b.Craig, M. Sonography: An Occupational Hazard? Journal of Diagnostic Medical Sonography. 3 (1985), 121-125. c.Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. Musculoskeletal Pain in Cardiac Ultrasonographers:

Results of a Random Survey. Journal of American Society of Echocardiography. (May1997), 357-362. d.Wihlidal, L.M. and S. Kumar. An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta. International Journal of Industrial Ergonomics. 19 (1997), 205-216. Chapter 6: Safety 85 e.Habes, D.J. and S. Baron. Health Hazard Report 99-0093-2749. University of Medicine and Dentistry of New Jersey. (1999). f.Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers. Journal of Medicine. 35:6 (1993), 605-610. Position the system Promote comfortable shoulder, arm, and hand postures Useastandtosupporttheweightoftheultrasoundsystem. Minimize eye and neck strain Ifpossible,positionthesystemwithinreach. Adjusttheangleofthesystemanddisplaytominimizeglare. Ifusingastand,adjustitsheightsothatthedisplayisatorslightlybeloweyelevel. Position yourself Support your back during an exam Useachairthatsupportsyourlowerback,thatadjuststoyourworksurfaceheight,that promotesanaturalbodyposture,andthatallowsquickheightadjustments. Alwayssitorstandupright.Avoidbendingorstooping. Minimize reaching and twisting Useabedthatisheightadjustable. Positionthepatientasclosetoyouaspossible. Faceforward.Avoidtwistingyourheadorbody. Moveyourentirebodyfronttoback,andpositionyourscanningarmnexttoorslightlyin frontofyou. Standfordifficultexamstominimizereaching. Positiontheultrasoundsystemordisplaydirectlyinfrontofyou. Provideanauxiliarymonitorforpatientviewing. Promote comfortable shoulder and arm postures Keepyourelbowclosetoyourside. Relaxyourshouldersinalevelposition. Supportyourarmusingasupportcushionorpillow,orrestitonthebed. 86 S a f e t y Promote comfortable hand, wrist, and finger postures Holdthetransducerlightlyinyourfingers. Minimizethepressureappliedonthepatient. Keepyourwristinastraightposition. Take breaks, exercise, and vary activities Minimizingscanningtimeandtakingbreakscaneffectivelyallowyourbodytorecoverfrom physicalactivityandhelpyouavoidMSDs.Someultrasoundtasksmayrequirelongeror morefrequentbreaks.However,simplychangingtaskscanhelpsomemusclegroupsrelax whileothersremainorbecomeactive. Workefficientlybyusingthesoftwareandhardwarefeaturescorrectly. Keepmoving.Avoidsustainingthesameposturebyvaryingyourhead,neck,body,arm, andlegpositions. Dotargetedexercises.Targetedexercisescanstrengthenmusclegroups,whichmayhelpyou avoidMSDs.Contactaqualifiedhealthprofessionaltodeterminestretchesandexercises thatarerightforyou. Electrical safety classification Class I equipment Internally powered equipment Ultrasound system powered from power supply or part of the Mobile Docking System Ultrasound system not connected to the power supply

(battery only) Type BF applied parts Type CF applied parts Ultrasound transducers ECG module/ECG leads IPX-7 (watertight equipment) Ultrasound transducers IPX-8 (watertight equipment) Footswitch Non AP/APG Ultrasound system power supply, docking system, and peripherals. Equipment is not suitable for use in the presence of flammable anaesthetics. Chapter 6: Safety 87 Electrical safety ThissystemmeetsEN606011,ClassI/internallypoweredequipmentrequirementsandType BFisolatedpatientappliedpartssafetyrequirements. Thissystemcomplieswiththeapplicablemedicalequipmentrequirementspublishedinthe CanadianStandardsAssociation(CSA),EuropeanNormHarmonizedStandards,and UnderwritersLaboratories(UL)safetystandards.SeeChapter 8,Specifications. Formaximumsafetyobservethefollowingwarningsandcautions. WARNING:

To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the patient. Under certain circumstances, the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system. This does not include the transducer face. To avoid discomfort or minor risk of operator injury when handling the transducer connector, the system should not be operated for more than 60 minutes continuously in a live-scan mode (as opposed to freeze or sleep modes). To avoid the risk of electrical shock or injury, do not open the system enclosures. All internal adjustments and replacements, except battery replacement, must be made by a qualified technician. To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. Explosion can result. To avoid the risk of electrical shock, use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent. The grounding wire must not be removed or defeated. To avoid the risk of electrical shock, when using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt, operate the system on battery power only without using the power supply. To avoid the risk of electrical shock, do not connect the systems power supply or a docking system to an MPSO or extension cord. To avoid the risk of electrical shock, before using the transducer, inspect the transducer face, housing, and cable. Do not use the transducer if the transducer or cable is damaged. To avoid the risk of electrical shock, always disconnect the power supply from the system before cleaning the system. 88 S a f e t y WARNING:

To avoid the risk of electrical shock, do not use any transducer that has been immersed beyond the specified cleaning or disinfection level. See Chapter 5, Troubleshooting and Maintenance. To avoid the risk of electrical shock to the patient, do not simultaneously touch the patient and the ungrounded signal input/output connectors on the back of the ultrasound system. To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC power cords, cables, and plugs on a regular basis. Ensure that they are not damaged. To avoid the risk of electrical shock and fire hazard, the power cord set that connects the power supply of the ultrasound system or MDS to mains power must only be used with the power supply or docking system, and cannot be used to connect other devices to mains power. To avoid the risk of electrical shock, use only accessories and peripherals recommended by SonoSite, including the power supply. Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommend by SonoSite. To avoid the risk of electrical shock, use commercial grade peripherals recommended by SonoSite on battery power only. Do not connect these products to AC mains power when using the system to scan or diagnose a patient/subject. Contact SonoSite or your local representative for a list of the commercial grade peripherals available from or recommended by SonoSite. To avoid the risk of electrical shock to the patient/subject, do not touch the system battery contacts while simultaneously touching a patient/subject. To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse. To avoid possible electrical shock or electromagnetic interference, verify proper operation and compliance with relevant safety standards for all equipment before clinical use. Connecting additional equipment to the ultrasound system constitutes configuring a medical system. SonoSite recommends verifying that the system, all combinations of equipment, and accessories connected to the ultrasound system comply with JACHO installation requirements and/or safety standards such as AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic compatibility standard IEC 60601-1-2 (Electromagnetic compatibility), and are certified according to IEC Standard 60950 (Information Technology Equipment (ITE)). Caution:

Do not use the system if an error message appears on the image display: note the error code; call SonoSite or your local representative; turn off the system by pressing and holding the power key until the system powers down. To avoid increasing the system and transducer connector temperature, do not block the airflow to the ventilation holes on the side of the system. Chapter 6: Safety 89 Equipment safety Toprotectyourultrasoundsystem,transducer,andaccessories,followtheseprecautions. Caution:

Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 5, Troubleshooting and Maintenance. Do not submerge the transducer connector in solution. The cable is not liquid-tight beyond the transducer connector/cable interface. Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system. Remove the battery from the system if the system is not likely to be used for some time. Do not spill liquid on the system. Battery safety Topreventthebatteryfrombursting,igniting,oremittingfumesandcausingpersonalinjury orequipmentdamage,observethefollowingprecautions. WARNING:

The battery has a safety device. Do not disassemble or alter the battery. Charge the batteries only when the ambient temperature is between 0 and 40C

(32 and 104F). Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects. Do not touch battery contacts. Do not heat the battery or discard it in a fire. Do not expose the battery to temperatures over 60C (140F). Keep it away from fire and other heat sources. Do not charge the battery near a heat source, such as a fire or heater. Do not leave the battery in direct sunlight. Do not pierce the battery with a sharp object, hit it, or step on it. Do not use a damaged battery. Do not solder a battery. The polarity of the battery terminals are fixed and cannot be switched or reversed. Do not force the battery into the system. 90 Do not connect the battery to an electrical power outlet. WARNING:

Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles. If the battery leaks or emits an odor, remove it from all possible flammable sources. S a f e t y Caution:

To avoid the battery bursting, igniting, or emitting fumes from the battery and causing equipment damage, observe the following precautions:

Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave oven or pressurized container. If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult SonoSite or your local representative. Store the battery between -20C (-4F) and 60C (140F). Use only SonoSite batteries. Do not use or charge the battery with non-SonoSite equipment. Only charge the battery with the system. Chapter 6: Safety 91 Clinical safety WARNING:

Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis. To avoid the risk of a burn hazard, do not use the transducer with high frequency surgical equipment. Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection. Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use. Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle and follow the prudent use information concerning MI and TI. SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz. Some SonoSite transducers are approved for intraoperative applications if a market-cleared sheath is used. To avoid injury or reduce the risk of infection to the patient, observe the following:

Follow Universal Precautions when inserting and maintaining a medical device for interventional and intraoperative procedures. Appropriate training in interventional and intraoperative procedures as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer is required. During vascular access, the potential exists for serious complications including without limitation the following: pneumothorax, arterial puncture, guidewire misplacement, and risks normally associated with local or general anesthesia, surgery, and post-operative recovery. To avoid device damage or patient injury, do not use the P10x, P17x, or P21x needle guide bracket on patients with pacemakers or medical electronic implants. The needle guide bracket for the P10x, P17x, and P21x transducers contains a magnet that is used to ensure the bracket is correctly oriented on the transducer. The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect. 92 Hazardous materials WARNING:

The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly in accordance with local regulations. S a f e t y Electromagnetic compatibility Theultrasoundsystemhasbeentestedandfoundtocomplywiththeelectromagnetic compatibility(EMC)limitsformedicaldevicestoIEC6060112:2001.Theselimitsaredesigned toprovidereasonableprotectionagainstharmfulinterferenceinatypicalmedicalinstallation. Caution:

Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the ultrasound system. Evidence of disruption may include image degradation or distortion, erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs, survey the site to determine the source of disruption, and take the following actions to eliminate the source(s). Increase distance between interfering equipment and your ultrasound system. Turn equipment in the vicinity off and on to isolate disruptive equipment. Relocate or re-orient interfering equipment. Manage use of frequencies close to ultrasound system frequencies. Remove devices that are highly susceptible to EMI. Lower power from internal sources within facility control (such as paging systems). Label devices susceptible to EMI. Educate clinical staff to recognize potential EMI-related problems. Eliminate or reduce EMI with technical solutions (such as shielding). Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI. Share relevant EMI information with others, particularly when evaluating new equipment purchases which may generate EMI. Purchase medical devices that comply with IEC 60601-1-2 EMC Standards. Chapter 6: Safety 93 Caution:

To avoid the risk of increased electromagnetic emissions or decreased immunity, use only accessories and peripherals recommended by SonoSite. Connection of accessories and peripherals not recommended by SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite. See the SonoSite accessories user guide. Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats. Manufacturers declaration Table 1andTable 2documenttheintendeduseenvironmentandEMCcompliancelevelsofthe system.Formaximumperformance,ensurethatthesystemisusedintheenvironments describedinthistable. Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Table 1: Manufacturers Declaration - Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment The SonoSite 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. The SonoSite ultrasound system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes. RF emissions ClSPR 11 RF emissions ClSPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Group 1 Class A Class A Complies 94 S a f e t y Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Table 2: Manufacturers Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge (ESD) IEC 61000-4-2 2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air 2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air Electrical fast Transient burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2KV on the mains 1KV on signal lines 2KV on the mains 1KV on signal lines 0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

>5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

>5% UT

(>95% dip in UT) for 5s 0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

>5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

>5% UT

(>95% dip in UT) for 5s Electromagnetic Environment Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the SonoSite ultrasound system requires continued operation during power mains interruptions, it is recommended that the SonoSite ultrasound system be powered from an uninterruptible power supply or a battery. Chapter 6: Safety 95 Table 2: Manufacturers Declaration - Electromagnetic Immunity (Continued) Immunity Test IEC 60601 Test Level Compliance Level 3 A/m 3 A/m Power Frequency Magnetic Field IEC 61000-4-8 Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 Vim 80 MHz to 2.5 GHz 3 V/m Electromagnetic Environment If image distortion occurs, it may be necessary to position the SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low. Portable and mobile RF communications equipment should be used no closer to any part of the SonoSite ultrasound system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance d = 1.2 P P d = 1.2 80 MHz to 800 MHz P d = 2.3 800 MHz to 2,5 GHz Where 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). 96 Table 2: Manufacturers Declaration - Electromagnetic Immunity (Continued) Immunity Test IEC 60601 Test Level Compliance Level Radiated RF IEC 61000-4-3

(continued) S a f e t y Electromagnetic Environment 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:

(IEC 60417 No. 417-IEC-5140:

Source of non-ionizing radiation) Note: UT is the AC mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a.Field 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 SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. ALARA principle ALARAistheguidingprinciplefortheuseofdiagnosticultrasound.Sonographersandother qualifiedultrasoundusers,usinggoodjudgmentandinsight,determinetheexposurethatis aslowasreasonablyachievable.Therearenosetrulestodeterminethecorrectexposurefor everysituation.Thequalifiedultrasounduserdeterminesthemostappropriatewaytokeep exposurelowandbioeffectstoaminimum,whileobtainingadiagnosticexamination. Athoroughknowledgeoftheimagingmodes,transducercapability,systemsetupand scanningtechniqueisnecessary.Theimagingmodedeterminesthenatureoftheultrasound beam.Astationarybeamresultsinamoreconcentratedexposurethanascannedbeam,which spreadsthatexposureoverthatarea.Thetransducercapabilitydependsuponthefrequency, Chapter 6: Safety 97 penetration,resolution,andfieldofview.Thedefaultsystempresetsareresetatthestartof eachnewpatient.Itisthescanningtechniqueofthequalifiedultrasounduseralongwith patientvariabilitythatdeterminesthesystemsettingsthroughouttheexam. ThevariableswhichaffectthewaythequalifiedultrasounduserimplementstheALARA principleinclude:patientbodysize,locationofthebonerelativetothefocalpoint,attenuation inthebody,andultrasoundexposuretime.Exposuretimeisanespeciallyusefulvariable, becausethequalifiedultrasoundusercancontrolit.Theabilitytolimittheexposureovertime supportstheALARAprinciple. Applying ALARA Thesystemimagingmodeselectedbythequalifiedultrasounduserisdeterminedbythe diagnosticinformationrequired.2Dimagingprovidesanatomicalinformation;CPDimaging providesinformationabouttheenergyoramplitudestrengthoftheDopplersignalovertime atagivenanatomicallocationandisusedfordetectingthepresenceofbloodflow;Color imagingprovidesinformationabouttheenergyoramplitudestrengthoftheDopplersignal overtimeatagivenanatomicallocationandisusedfordetectingthepresence,velocity,and directionofbloodflow;TissueHarmonicImaginguseshigherreceivedfrequenciestoreduce clutter,artifact,andimproveresolutiononthe2Dimage.Understandingthenatureofthe imagingmodeusedallowsthequalifiedultrasoundusertoapplytheALARAprinciple. Prudentuseofultrasoundrequiresthatpatientexposuretoultrasoundbelimitedtothelowest ultrasoundoutputfortheshortesttimenecessarytoachieveacceptablediagnosticresults. Decisionsthatsupportprudentusearebasedonthetypeofpatient,examtype,patienthistory, easeordifficultyofobtainingdiagnosticallyusefulinformation,andpotentiallocalized heatingofthepatientduetotransducersurfacetemperature. Thesystemhasbeendesignedtoensurethattemperatureatthefaceofthetransducerwillnot exceedthelimitsestablishedinSection42ofEN60601237:Particularrequirementforthe safetyofultrasoundmedicaldiagnosticandmonitoringequipment.SeeTransducersurface temperatureriseonpage 104.Intheeventofadevicemalfunction,thereareredundant controlsthatlimittransducerpower.Thisisaccomplishedbyanelectricaldesignthatlimits bothpowersupplycurrentandvoltagetothetransducer. Thesonographerusesthesystemcontrolstoadjustimagequalityandlimitultrasoundoutput. Thesystemcontrolsaredividedintothreecategoriesrelativetooutput:controlsthatdirectly affectoutput,controlsthatindirectlyaffectoutput,andreceivercontrols. Direct controls Thesystemdoesnotexceedaspatialpeaktemporalaverageintensity(ISPTA)of720 mW/cm2 forallimagingmodes.(ForeithertheOphthalmicorOrbitalexam,theacousticoutputis limitedtothefollowingvalues:ISPTAdoesnotexceed50 mW/cm2;TIdoesnotexceed1.0,and MIdoesnotexceed0.23.)Themechanicalindex(MI)andthermalindex(TI)mayexceedvalues greaterthan1.0onsometransducersinsomeimagingmodes.OnemaymonitortheMIandTI valuesandadjustthecontrolstoreducethesevalues.SeeGuidelinesforreducingMIandTI 98 onpage 99.Additionally,onemeansformeetingtheALARAprincipleistosettheMIorTI valuestoalowindexvalueandthenmodifyingthisleveluntilasatisfactoryimageorDoppler modeisobtained.FormoreinformationonMIandTI,seeBSEN60601237:2001:AnnexHH. Indirect controls Thecontrolsthatindirectlyaffectoutputarecontrolsaffectingimagingmode,freeze,and depth.Theimagingmodedeterminesthenatureoftheultrasoundbeam.Tissueattenuationis directlyrelatedtotransducerfrequency.ThehigherthePRF(pulserepetitionfrequency),the moreoutputpulsesoccuroveraperiodoftime. Receiver controls Thereceivercontrolsarethegaincontrols.Receivercontrolsdonotaffectoutput.Theyshould beused,ifpossible,toimproveimagequalitybeforeusingcontrolsthatdirectlyorindirectly affectoutput. S a f e t y Acoustic artifacts Anacousticartifactisinformation,presentorabsentinanimage,thatdoesnotproperly indicatethestructureorflowbeingimaged.Therearehelpfulartifactsthataidindiagnosisand thosethathinderproperinterpretation.Examplesofartifactsinclude:

Shadowing Throughtransmission Aliasing Reverberations Comettails Formoreinformationondetectingandinterpretingacousticartifacts,seethefollowing reference:

Kremkau,FrederickW.DiagnosticUltrasound:PrinciplesandInstruments.7thed.,W.B. SaundersCompany,(Oct.17,2005). Guidelines for reducing MI and TI ThefollowingaregeneralguidelinesforreducingMIorTI.Ifmultipleparametersaregiven, thebestresultsmaybeachievedbyminimizingtheseparameterssimultaneously.Insome modeschangingtheseparametersdoesnotaffectMIorTI.Changestootherparametersmay alsoresultinMIandTIreductions.PleasenotetheMIandTIvaluesontherightsideofthe screen. Chapter 6: Safety 99 Table 3: MI Transducer Depth C11x C60x HFL38x ICTx L25x L38x P10x P21x SLAx TEEx Decrease or lower setting of parameter to reduce MI. Increase or raise setting of parameter to reduce MI. Table 4: TI (TIS, TIC, TIB) Color Power Doppler Settings Transducer Box Width Box Height Box Depth PRF Depth Optimize PW Settings C11x C60x HFL38x ICTx L25x L38x P10x P21x

(Depth)

(PRF)

(Depth)

(PRF)

(PRF)

(Depth)

(PRF)

(PRF) Exam Gyn 100 Table 4: TI (TIS, TIC, TIB) Color Power Doppler Settings Transducer Box Width Box Height Box Depth PRF Depth Optimize PW Settings S a f e t y SLAx TEEx

(PRF)

(PRF) Decrease or lower setting of parameter to reduce MI. Increase or raise setting of parameter to reduce MI. Chapter 6: Safety 101 Output display ThesystemmeetstheAIUMoutputdisplaystandardforMIandTI(seelastreferencein Relatedguidancedocumentsbelow).Table 5indicatesforeachtransducerandoperating modewheneithertheTIorMIisgreaterthanorequaltoavalueof1.0,thusrequiringdisplay. Note: TheD2xtransducerhasastaticcontinuouswave(CW)output.Thisoutputisfixed.Therefore, TIandMIvaluescannotbechangedbyanysystemcontrolsavailabletotheuser. Table 5: TI or MI 1.0 Transducer Model Index C11x/8-5 MI TIC,TIB, or TIS C60x/5-2 MI TIC, TIB, or TIS D2x/2 MI TIC,TIB, or TIS HFL38x/13-6 MI TIC, TIB, or TIS ICTx/8-5 MI TIC, TIB, or TIS L25x/13-6 MI TIC,TIB, or TIS L38x/10-5 MI TIC, TIB, or TIS P10x/8-4 MI TIC, TIB, or TIS P21x/5-1 MI TIC, TIB, or TIS SLAx/13-6 MI TIC, TIB, or TIS 2D/

M Mode CPD/

Color PW Doppler CW Doppler No No Yes No No No No No No No No No No Yes Yes Yes No No No Yes No No Yes Yes No No Yes No Yes Yes Yes Yes Yes Yes No No No Yes No Yes Yes Yes No Yes No Yes Yes Yes Yes Yes Yes Yes No Yes No Yes No Yes No Yes 102 Table 5: TI or MI 1.0 (Continued) Transducer Model Index TEEx/8-3 MI TIC, TIB, or TIS 2D/

M Mode No No CPD/

Color No No PW Doppler CW Doppler No Yes No Yes S a f e t y EvenwhenMIislessthan1.0,thesystemprovidesacontinuousrealtimedisplayofMIinall imagingmodes,inincrementsof0.1. ThesystemmeetstheoutputdisplaystandardforTIandprovidesacontinuousrealtime displayofTIinallimagingmodes,inincrementsof0.1. TheTIconsistsofthreeuserselectableindices,andonlyoneoftheseisdisplayedatanyone time.InordertodisplayTIproperlyandmeettheALARAprinciple,theuserselectsan appropriateTIbasedonthespecificexambeingperformed.SonoSiteprovidesacopyofAIUM MedicalUltrasoundSafety,whichcontainsguidanceondeterminingwhichTIisappropriate(See Relatedguidancedocumentsonpage 104). MI and TI output display accuracy TheaccuracyresultfortheMIisstatedstatistically.With95%confidence,95%ofthemeasured MIvalueswillbewithin+18%to25%ofthedisplayedMIvalue,or+0.2ofthedisplayedvalue, whichevervalueislarger. TheaccuracyresultfortheTIisstatedstatistically.With95%confidence,95%ofthemeasured TIvalueswillbewithin+21%to40%ofthedisplayedTIvalue,or+0.2ofthedisplayedvalue, whichevervalueislarger.Thevaluesequateto+1dBto3dB. Adisplayedvalueof0.0forMIorTImeansthatthecalculatedestimatefortheindexislessthan 0.05. Factors that contribute to display uncertainty Thenetuncertaintyofthedisplayedindicesisderivedbycombiningthequantifieduncertainty fromthreesources:measurementuncertainty,systemandtransducervariability,and engineeringassumptionsandapproximationsmadewhencalculatingthedisplayvalues. Measurementerrorsoftheacousticparameterswhentakingthereferencedataarethemajor sourceoferrorthatcontributestothedisplayuncertainty.Themeasurementerrorisdescribed inAcousticmeasurementprecisionanduncertaintyonpage 133. ThedisplayedMIandTIvaluesarebasedoncalculationsthatuseasetofacousticoutput measurementsthatweremadeusingasinglereferenceultrasoundsystemwithasingle referencetransducerthatisrepresentativeofthepopulationoftransducersofthattype.The referencesystemandtransducerarechosenfromasamplepopulationofsystemsand transducerstakenfromearlyproductionunits,andtheyareselectedbasedonhavingan acousticoutputthatisrepresentativeofthenominalexpectedacousticoutputforall transducer/systemcombinationsthatmightoccur.Ofcourseeverytransducer/system Chapter 6: Safety 103 combinationhasitsownuniquecharacteristicacousticoutput,andwillnotmatchthenominal outputonwhichthedisplayestimatesarebased.Thisvariabilitybetweensystemsand transducersintroducesanerrorintodisplayedvalue.Bydoingacousticoutputsampling testingduringproduction,theamountoferrorintroducedbythevariabilityisbounded.The samplingtestingensuresthattheacousticoutputoftransducersandsystemsbeing manufacturedstayswithinaspecifiedrangeofthenominalacousticoutput. Anothersourceoferrorarisesfromtheassumptionsandapproximationsthataremadewhen derivingtheestimatesforthedisplayindices.Chiefamongtheseassumptionsisthatthe acousticoutput,andthusthederiveddisplayindices,arelinearlycorrelatedwiththetransmit drivevoltageofthetransducer.Generally,thisassumptionisverygood,butitisnotexact,and thussomeerrorinthedisplaycanbeattributedtotheassumptionofvoltagelinearity. Related guidance documents InformationforManufacturersSeekingMarketingClearanceofDiagnosticUltrasound SystemsandTransducers,FDA,1997. MedicalUltrasoundSafety,AmericanInstituteofUltrasoundinMedicine(AIUM),1994.(A copyisincludedwitheachsystem.) AcousticOutputMeasurementStandardforDiagnosticUltrasoundEquipment,NEMA UD22004. AcousticOutputMeasurementandLabelingStandardforDiagnosticUltrasoundEquipment, AmericanInstituteofUltrasoundinMedicine,1993. StandardforRealTimeDisplayofThermalandMechanicalAcousticOutputIndiceson DiagnosticUltrasoundEquipment,NEMAUD32004. GuidanceontheinterpretationofTIandMItobeusedtoinformtheoperator,AnnexHH,BS EN60601237reprintedatP05699. Transducer surface temperature rise Table 6andTable 7listthemeasuredsurfacetemperaturerisefromambient(23C3C)of transducersusedontheultrasoundsystem.Thetemperaturesweremeasuredinaccordance withEN60601237section42withcontrolsandsettingspositionedtogivemaximum temperatures Table 6: Transducer Surface Temperature Rise, External Use (C) Test C11x C60x Still air 17.6 16.2 Simulated Use 9.1 8.8 D2 8.3 1.9 HFL38x L25x L38x P10x P21x 15.5 16.1 16.3 15.6 16.8 7.9 8.5 9.6 9.8 9.0 104 S a f e t y Table 7: Transducer Surface Temperature Rise, Internal Use (C ) Test ICTx SLAx TEEx Still air Simulated Use 9.2 5.2 9.5 4.8 9.3 5.8 Acoustic output measurement Sincetheinitialuseofdiagnosticultrasound,thepossiblehumanbiologicaleffects(bioeffects) fromultrasoundexposurehavebeenstudiedbyvariousscientificandmedicalinstitutions.In October1987,theAmericanInstituteofUltrasoundinMedicine(AIUM)ratifiedareportfrom itsBioeffectsCommittee(BioeffectsConsiderationsfortheSafetyofDiagnosticUltrasound,J UltrasoundMed.,Sept.1988:Vol.7,No.9Supplement).Thereport,sometimesreferredtoas theStoweReport,reviewedavailabledataonpossibleeffectsofultrasoundexposure.Another report,BioeffectsandSafetyofDiagnosticUltrasound,datedJanuary28,1993,provides morecurrentinformation. Theacousticoutputforthisultrasoundsystemhasbeenmeasuredandcalculatedin accordancewithAcousticOutputMeasurementStandardforDiagnosticUltrasound Equipment(NEMAUD22004),andStandardforRealTimeDisplayofThermaland MechanicalAcousticOutputIndicesonDiagnosticUltrasoundEquipment(NEMA UDe32004). In Situ, derated, and water value intensities Allintensityparametersaremeasuredinwater.Sincewaterdoesnotabsorbacousticenergy, thesewatermeasurementsrepresentaworstcasevalue.Biologicaltissuedoesabsorbacoustic energy.Thetruevalueoftheintensityatanypointdependsontheamount,typeoftissue,and thefrequencyoftheultrasoundpassingthroughthetissue.Theintensityvalueinthetissue, In Situ,hasbeenestimatedbyusingthefollowingformula:

In Situ=Water[e(0.23alf)]

where:

In Situ=In Situintensityvalue Water=Waterintensityvalue e=2.7183 a=attenuationfactor(dB/cm MHz) Chapter 6: Safety 105 Attenuationfactor(a)forvarioustissuetypesaregivenbelow:

brain=0.53 heart=0.66 kidney=0.79 liver=0.43 muscle=0.55 l=skinlinetomeasurementdepthincm f=centerfrequencyofthetransducer/system/modecombinationinMHz Sincetheultrasonicpathduringtheexamislikelytopassthroughvaryinglengthsandtypes oftissue,itisdifficulttoestimatethetrueIn Situintensity.Anattenuationfactorof0.3isused forgeneralreportingpurposes;therefore,theIn Situvaluecommonlyreportedusesthe formula:

In Situ(derated)=Water[e(0.069lf)]

SincethisvalueisnotthetrueIn Situintensity,thetermderatedisusedtoqualify it. Themaximumderatedandthemaximumwatervaluesdonotalwaysoccuratthesame operatingconditions;therefore,thereportedmaximumwaterandderatedvaluesmaynotbe relatedbytheIn Situ(derated)formula.Forexample:amultizonearraytransducerthathas maximumwatervalueintensitiesinitsdeepestzone,butalsohasthesmallestderatingfactor inthatzone.Thesametransducermayhaveitslargestderatedintensityinoneofitsshallowest focalzones. Tissue models and equipment survey TissuemodelsarenecessarytoestimateattenuationandacousticexposurelevelsIn Situfrom measurementsofacousticoutputmadeinwater.Currently,availablemodelsmaybelimitedin theiraccuracybecauseofvaryingtissuepathsduringdiagnosticultrasoundexposuresand uncertaintiesintheacousticpropertiesofsofttissues.Nosingletissuemodelisadequatefor predictingexposuresinallsituationsfrommeasurementsmadeinwater,andcontinued improvementandverificationofthesemodelsisnecessaryformakingexposureassessments forspecificexamtypes. Ahomogeneoustissuemodelwithattenuationcoefficientof0.3 dB/cm MHzthroughoutthe beampathiscommonlyusedwhenestimatingexposurelevels.Themodelisconservativein thatitoverestimatestheIn Situacousticexposurewhenthepathbetweenthetransducerand siteofinterestiscomposedentirelyofsofttissue.Whenthepathcontainssignificantamounts offluid,asinmanyfirstandsecondtrimesterpregnanciesscannedtransabdominally,this modelmayunderestimatetheIn Situacousticexposure.Theamountofunderestimation dependsuponeachspecificsituation. 106 S a f e t y Fixedpathtissuemodels,inwhichsofttissuethicknessisheldconstant,sometimesareusedto estimateIn Situacousticexposureswhenthebeampathislongerthan3 cmandconsistslargely offluid.Whenthismodelisusedtoestimatemaximumexposuretothefetusduring transabdominalscans,avalueof1 dB/cm MHzmaybeusedduringalltrimesters. Existingtissuemodelsthatarebasedonlinearpropagationmayunderestimateacoustic exposureswhensignificantsaturationduetononlineardistortionofbeamsinwaterispresent duringtheoutputmeasurement. Themaximumacousticoutputlevelsofdiagnosticultrasounddevicesextendoverabroad rangeofvalues:

Asurveyof1990equipmentmodelsyieldedMIvaluesbetween0.1 and1.0attheirhighest outputsettings.MaximumMIvaluesofapproximately2.0areknowntooccurforcurrently availableequipment.MaximumMIvaluesaresimilarforrealtime2DandM Modeimaging. Computedestimatesofupperlimitstotemperatureelevationsduringtransabdominalscans wereobtainedinasurveyof1988and1990pulsedDopplerequipment.Thevastmajorityof modelsyieldedupperlimitslessthan1and4C(1.8and7.2F)forexposuresof firsttrimesterfetaltissueandsecondtrimesterfetalbone,respectively.Thelargestvalues obtainedwereapproximately1.5C(2.7F)forfirsttrimesterfetaltissueand7C(12.6F)for secondtrimesterfetalbone.Estimatedmaximumtemperatureelevationsgivenherearefor afixedpathtissuemodelandarefordeviceshavingISPTAvaluesgreaterthan500 mW/

cm2.Thetemperatureelevationsforfetalboneandtissuewerecomputedbasedon calculationproceduresgiveninSections4.3.2.14.3.2.6inBioeffectsandSafetyofDiagnostic Ultrasound(AIUM,1993). Acoustic output tables Table 8throughTable 31indicatetheacousticoutputforthesystemandtransducer combinationswithaTIorMIequaltoorgreaterthanone.Thesetablesareorganizedby transducermodelandimagingmode.Foradefinitionoftermsusedinthetables,seeTerms usedintheacousticoutputtablesonpage 132. Chapter 6: Safety 107 Table 8: Transducer Model: C11x/8-5 Operating Mode: CPD/Color M.I.

(a)

Scan

(a)

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Mode n o i t i d n o C Control 2: Exam Type Control 3: PRF Control 4: Optimization/Depth Control 5: Color Box Position/ Size TIC 1.2 40.50 4.38 0.36 0.5 1.56 2.5 CPD Vas 2841 Med/2.0 Top/

Short

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 108 Table 9: Transducer Model: C11x/8-5 Operating Mode: PW Doppler M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1

(a)

Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Exam Type n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position S a f e t y TIB Non-scan 1.8 TIC 1.7 26.29 24.65 1.1 0.236 4.36 0.28 0.5 0.226 Any 2 mm 3906 Zone 1 4.36 0.2 0.5 0.77 2.5 Any 3 mm 3906 Zone 0

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 109 Table 10: Transducer Model: C60x/5-2 Operating Mode: 2D TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

Scan

(a)

Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: THI Control 5: MB (Multi Beam) c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C M.I. 1.0 1.69 4.7 2.84

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 0.579

(Hz) 5440

(MPa) 2.679

(cm) FLx (cm) FLy (cm)

(W/cm2) 197.7 Abd/

OB Any 11/

13 cm On On

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 110 Table 11: Transducer Model: C60x/5-2 Operating Mode: M Mode Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type n o i t i d n o C Control 2: Optimization Control 3: Depth Control 4: MB (Multi Beam) S a f e t y TIS Non-scan Aaprt1 Aaprt>1

(a)

TIB Non-scan

(a)

TIC

(b)

Scan M.I. 1.0 1.62 4.7 2.85

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(Hz)

(sec) 0.577 800

(MPa) 2.576

(cm) FLx (cm) FLy (cm)

(W/cm2) 184.3 Any Pen 7.8 cm Off or On

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 111 Table 12: Transducer Model: C60x/5-2 Operating Mode: PW Doppler M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Exam Type n o i t i d n o C Control 2: PRF Control 3: Sample Volume Control 4: Sample Volume Position TIC

(b)

TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

3.1 85.64 1.255 0.51 2.233 0.6552 1.3 0.415 Abd Any 12 mm Zone 1

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 112 Table 13: Transducer Model: D2x/2 Operating Mode: CW Doppler Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type Control 2: Depth Control 3: Zone n o i t i d n o C n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C S a f e t y M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

2.6 90.52 1.1 0.66 2.00 0.8 0.4 0.54 Crd Fixed Fixed TIC

(b)

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 113 Table 14: Transducer Model: HFL38x/13-6 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) IPA.3@MImax Control 1: Mode Control 2: Exam Type Control 3: Optimization/Depth/PRF Control 4: Color Box Position/Size c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C TIS Non-scan Aaprt1 Aaprt>1 TIB Non-

scan TIC

(b)

M.I. 1.1 2.556 1.2 5.328 0.525 2597 3.187 325.5 Color Any Low/3.3 cm/

393 Any Scan 1.0 53.49 5.324 0.44 0.4 1.32 2.5 Color Any Med/

2.7 cm/

1938 Top/

Short

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 114 S a f e t y Table 15: Transducer Model: HFL38x/13-6 Operating Mode: PW Doppler Index Label Global Maximum Index Value c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) g n i t a r e p O l o r t n o C s n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position Scan M.I. 1.0 2.37 0.9 5.32 1.29 1008 2.404 323.35 Bre/Vas SmP/IMT 1 mm 1008 Zone 2 TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan 2.2 46.55 1.1 0.33 5.33 1.04 0.4 0.46 1.2 46.55 5.33 1.04 0.4 3.72 2.5 Vas/Ven/

IMT 12 mm 10417 Zone 7 Vas/Ven/

IMT 12 mm 10417 Zone 7 TIC

(b)

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 115 Table 16: Transducer Model: ICTx/8-5 Operating Mode: PW Doppler M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1

(a)

Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Exam Type n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position TIB Non-scan 1.2 16.348 TIC

(a)

1.6 0.192 4.36 0.6 0.5 0.187 Any 3 mm Any Zone 1

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 116 S a f e t y Table 17: Transducer Model L25x/13-6 Operating Mode: PW Doppler Index Label Global Maximum Index Value c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) g n i t a r e p O l o r t n o C s n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position TIC

(b)

TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

1.6 14.02 0.6 0.155 6.00 0.16 0.3 0.1549 Vas/Nrv/

Ven 12 mm 20833 Zone 0

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 117 Table 18: Transducer Model: L38x/10-5 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) IPA.3@MImax Control 1: Mode Control 2: Exam Type Control 3: PRF Control 4: Optimization/Depth Control 5: Color Box Position/Size TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

M.I. 1.3 2.89 1.1 4.91 0.529 9547 3.48 439.3 Color Any 331 Scan 1.0 64.88 4.91 0.54 0.4 1.5 2.5 CPD Bre 2137 Any/3.1 Med/3.1 Any Def/

Def/Def

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C 118 Table 19: Transducer Model: L38x/10-5 Operating Mode: PW Doppler Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C IPA.3@MImax Control 1: Exam Type Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) S a f e t y Scan M.I. 1.04 2.345 0.8 5.01 1.29 1008 2.693 284.5 Any 1 mm 1008 Zone 0

(top) TIC

(b)

TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan 2.0 84.94 5.05 1.80 0.4 5.54 2.5 Vas 12 mm Any Zone 7 2.6 84.94 1.3 0.4685 5.05 1.80 0.4 0.2533 Vas 12 mm Any Zone 7

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 119 Table 20: Transducer Model: P10x/8-4 Operating Mode: 2D Mode Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type n o i t i d n o C Control 2: Optimization Control 3: Depth Control 4: MB/SonoHD n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C M.I.

(a)

Scan

(a)

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC 1.0 35.24 4.84 0.416 0.7 1.67 5.0 Neo Gen 2.0 Off/Off

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 120 Table 21: Transducer Model: P10x/8-4 Operating Mode: Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C IPA.3@MImax Control 1: Mode Control 2: Exam Type Control 3: Optimization/Depth/PRF Control 4: Color Box Pos/Size

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) S a f e t y M.I. 1.0 2.02 Scan

(a)

2.4 3.90 0.70 2772 2.80 252 Color Neo Low/

3.7/

772 Any/

Tall TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC 1.3 41.38 3.91 0.608 0.7 2.48 5.0 Color Abd Med/

2.0/

2315 Short/

Narrow

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 121 Table 22: Transducer Model: P10x/8-4 Operating Mode: PW Doppler Index Label Global Maximum Index Value M.I. 1.0 2.03 2.1 3.87 233 Crd 1 mm 1563/

Off Scan TIS Non-scan Aaprt1 Aaprt>1 1.2 36.25 6.86 0.992 0.7 6.74 5.0 Crd 7 mm Any/

On Zone 6 TIB Non-scan 2.0 TIC 1.8 34.4 31.5 0.8 0.32 3.84 0.416 0.7 0.25 Neo 12 mm 15625/

Off 3.86

.224 0.7 0.92 5.0 Crd 1 mm 5208/

Off Zone 2 Zone 1

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type Control 2: Sample Volume Control 3: PRF/TDI 1.28

(Hz) 1563 2.70 Control 4: Sample Volume Position Zone 3

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C 122 Table 23: Transducer Model: P10x/8-4 Operating Mode: CW Doppler Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type Control 2: Depth Control 3: Zone n o i t i d n o C n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1

(a)

S a f e t y TIB Non-scan 2.1 TIC 2.0 40.72 30.00 0.7 0.36 4.00 0.320 0.7 0.27 Card Any 4.00 0.16 0.7 0.92 5.0 Card Any Zone 3 Zone 0

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 123 Table 24: Transducer Model: P21x/5-1 Operating Mode: 2D Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: THI Control 5: Sector Width c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C Scan

(a)

M.I. 1.4 1.92 5.1 1.93

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 0.842 4000 2.53

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) 355.1 Card Res 4.7/7.5 cm On Narrow TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC 2.3 171.53 1.94 1.9 1.3 18.46 5.5 Card Pen 27 cm Off Narrow

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 124 Table 25: Transducer Model: P21x/5-1 Operating Mode: M Mode Index Label M.I. Scan TIS Non-scan Aaprt1 Aaprt>1

(a)

Global Maximum Index Value c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type g n i t a r e p O l o r t n o C s n o i t i d n o C Control 2: Optimization Control 3: Depth Control 4: THI Control 5: MB

(Multibeam) 1.5 2.10

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm) 3.645

(cm)

(MHz) X (cm) Y (cm) 1.93

(Hz)

(sec) 0.904 800

(MPa) 2.679

(cm) FLx (cm) FLy (cm)

(W/cm2) 237.4 Abd/

OB Any 7.5 cm On On S a f e t y TIB Non-scan 1.4 TIC 1.1 40.08 29.71 4.9 0.343 1.93 1.835 1.3 0.341 1.94 1.9 1.3 18.46 5.5 Abd/OB Abd/OB

/Card Gen/Res Pen 10/13 cm 27 cm On On or Off Off On or Off

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 125 Table 26: Transducer Model: P21x/5-1 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Mode Control 2: Exam Type M.I. 1.5 2.19 4.5 2.15

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 1.20

(Hz) 1063

(MPa) 2.574

(cm) FLx (cm) FLy (cm)

(W/cm2) 330.4 Color Abd/

OB TIS TIB Non-scan Aaprt1 Aaprt>1 Non-scan Scan 1.3 136.91 2.16 0.918 1.3 3.68 5.5 CPD OB Control 3: PRF/Depth Control 4: Color Optimization Control 5: THI Control 6: Color Box Size 300/10 850/7.5 Any On Any Med Off Short and Narrow TIC 2.4 137.5 2.16 0.918 1.3 3.68 5.5 Color Abd 751/7.5 Med Off Short and Narrow

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C 126 Table 27: Transducer Model: P21x/5-1 Operating Mode: PW Doppler Index Label M.I. Scan TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan S a f e t y TIC 2.7 Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Exam Type n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position 1.2

(MPa) 1.844

(mW)

(mW)

(cm)

(cm)

(cm) 3.718

(cm)

(MHz) X (cm) Y (cm)

(sec) 2.16 1.21

(Hz) 1562.5

(MPa) 2.432

(cm) FLx (cm) FLy (cm)

(W/cm2) 187.5 Card 1mm 1563 Zone 1 1.3 4.0 120.13 3.1 2.66 2.22 1.9 1.3 13.84 5.5 Card 3mm 3906 Zone 4 95.55 95.55 0.6 0.49 2.23 0.459 1.3 0.49 TCD 14mm 12500 Zone 0 2.23 0.459 1.3 1.55 5.5 TCD 14mm 12500 Zone 0

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 127 Table 28: Transducer Model: P21x/5-1 Operating Mode: CW Doppler Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type Control 2: Zone n o i t i d n o C n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan 1.0 3.4 TIC 2.9 102.54 1.386 1.71 2.00 0.786 1.3 13.84 5.5 88.30 101.73 1.255 0.49 2.00 0.655 1.3 0.45 2.00 0.459 1.3 1.55 5.5 Card Card Card Zone 4 Zone 1 Zone 0

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 128 S a f e t y Table 29: Transducer Model: SLAx/13-6 Operating Mode: PW Doppler Index Label Global Maximum Index Value c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) g n i t a r e p O l o r t n o C s n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Vol. Position TIC

(b)

TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

1.2 8.75 0.65 0.13 6.00 0.24 0.3 0.13 Vas, Nrv, Ven 5 mm 20833 Zone 2

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 129 Table 30: Transducer Model: TEEx/8-3 Operating Mode: PW Doppler M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Exam Type n o i t i d n o C Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position TIC

(b)

TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

1.7 29.29 0.6 0.34 3.84 0.261 0.9 0.34 Crd 1 mm 2604 Zone 1

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 130 Table 31: Transducer Model: TEEx/8-3 Operating Mode: CW Doppler Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type Control 2: Depth Control 3: Zone n o i t i d n o C n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C S a f e t y M.I.

(a)

Scan

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan

(a)

1.2 27.23 1.1 0.39 4.00 0.435 0.9 0.34 Crd Any Zone 3 TIC

(b)

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 131 Terms used in the acoustic output tables Table 32: Acoustic Output Terms and Definitions Term ISPTA.3 TI type TI value MI Definition Derated spatial peak, temporal average intensity in units of milliwatts/cm2. Applicable thermal index for the transducer, imaging mode, and exam type. Thermal index value for the transducer, imaging mode, and exam type. Mechanical index. Ipa.3@MImax Derated pulse average intensity at the maximum MI in units of W/cm2. TIS TIB TIC Aaprt Pr.3 Wo

(Soft tissue thermal index) is a thermal index related to soft tissues. TIS scan is the soft tissue thermal index in an auto-scanning mode. TIS non-scan is the soft tissue thermal index in the non-autoscanning mode.

(Bone thermal index) is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIB non-scan is the bone thermal index in the non-autoscanning mode.

(Cranial bone thermal index) is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body. Area of the active aperture measured in cm2. Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI (Megapascals). Ultrasonic power, except for TISscan, in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts. W.3(z1) ISPTA.3(z1) Derated ultrasonic power at axial distance z1 in units of milliwatts. Derated spatial-peak temporal-average intensity at axial distance z1

(milliwatts per square centimeter). z1 zbp zsp Axial distance corresponding to the location of maximum [min(W.3(z), ITA.3(z) x 1 cm2)], where z > zbp in centimeters. 1.69

Aaprt

) in centimeters. For MI, the axial distance at which pr.3 is measured. For TIB, the axial distance at which TIB is a global maximum (for example, zsp = zb.3) in centimeters. 132 Table 32: Acoustic Output Terms and Definitions (Continued) Term deq(z) Definition Equivalent beam diameter as a function of axial distance z, and is equal to

4 (

) Wo

ITA z( )

, where ITA(z) is the temporal-average intensity as a function of z in centimeters. S a f e t y fc Center frequency in MHz. Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in centimeters. PD PRF pr@PIImax deq@PIImax FL Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of MI. Pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI in Hertz. Peak rarefactional pressure at the point where the free-field, spatial-peak pulse intensity integral is a maximum in Megapascals. Equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity integral is a maximum in centimeters. Focal length, or azimuthal (x) and elevational (y) lengths, if different measured in centimeters. Acoustic measurement precision and uncertainty Alltableentrieshavebeenobtainedatthesameoperatingconditionsthatgiverisetothe maximumindexvalueinthefirstcolumnofthetable.Measurementprecisionanduncertainty forpower,pressure,intensity,andotherquantitiesthatareusedtoderivethevaluesinthe acousticoutputtableareshowninthetablebelow.InaccordancewithSection 6.4oftheOutput DisplayStandard,thefollowingmeasurementprecisionanduncertaintyvaluesare determinedbymakingrepeatmeasurementsandstatingthestandarddeviationasa percentage. Chapter 6: Safety 133 Table 33: Acoustic Measurement Precision and Uncertainty Quantity Precision

(% of standard deviation) Uncertainty

(95% confidence) Pr Pr.3 Wo fc PII PII.3 1.9%

1.9%

3.4%

0.1%

3.2%

3.2%

+11.2%

+12.2%

+10%

+4.7%

+12.5 to -16.8%

+13.47 to -17.5%

Labeling symbols Thefollowingsymbolsareusedontheproducts,packaging,andcontainers. Table 34: Labeling Symbols Symbol Definition Alternating Current (AC) Class 1 device indicating manufacturers declaration of conformance with Annex VII of 93/42/EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features, or to a Class IIa, IIb, or III device requiring verification or auditing by the Notified Body to applicable Annex(es) of 93/42/EEC Attention, see the user guide Device complies with relevant Australian regulations for electronic devices. LOT Batch code, date code, or lot code type of control number Biological risk 134 Table 34: Labeling Symbols (Continued) Symbol Definition Device complies with relevant Brazilian regulations for electro-medical devices. S a f e t y Canadian Standards Association. The C and US indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI/UL Standards, for use in Canada and the US, respectively. REF Catalog number Collect separately from other household waste (see European Commission Directive 93/86/EEC). Refer to local regulations for disposal. STERILE EO Contents sterilized using ethylene oxide process. Corrugated recycle Dangerous voltage Date of manufacture Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high. Chapter 6: Safety 135 Table 34: Labeling Symbols (Continued) Symbol Definition Do not stack over 10 high. Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices. Fragile GEL STERILE R Gel sterilized by radiation. Hot Indoor use only Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle SN Serial number type of control number Storage temperature conditions Submersible. Protected against the effects of temporary immersion. Water-Tight Equipment. Protected against the effects of extended immersion. 136 Table 34: Labeling Symbols (Continued) Symbol Definition Handle transducer with care. S a f e t y Follow manufacturers instructions for disinfecting time. Disinfect transducer. Type BF patient applied part

(B = body, F = floating applied part) Defibrillator proof type CF patient applied part Underwriters Laboratories labeling Pollution Control Logo. (Applies to all parts/products listed in the China RoHS disclosure table. May not appear on the exterior of some parts/products because of space limitations.) China Compulsory Certificate mark (CCC Mark). A compulsory safety mark for compliance to Chinese national standards for many products sold in the Peoples Republic of China. Contains mercury. (Applies to the LCD and may apply to other components in the ultrasound system.) WARNING: Connect Only Accessories and Peripherals Recommended by SonoSite WARNING:

Connect Only Accessories and Peripherals Recommended by SonoSite Chapter 6: Safety 137 138 Chapter 7: References Measurement accuracy Themeasurementsprovidedbythesystemdo notdefineaspecificphysiologicaloranatomical parameter.Rather,themeasurementsareofa physicalpropertysuchasdistanceforevaluation bytheclinician.Theaccuracyvaluesrequirethat youcanplacethecalipersoveronepixel.The valuesdonotincludeacousticanomaliesofthe body. The2Dlineardistancemeasurementresultsare displayedincentimeterswithoneplacepastthe decimalpoint,ifthemeasurementistenor greater;twoplacespastthedecimalpoint,ifthe measurementislessthanten. Thelineardistancemeasurementcomponents havetheaccuracyandrangeshowninthe followingtables. R e f e r e n c e s Table 1: 2D Measurement Accuracy and Range y c a r u c c A y B b d o h t e M t s e T

) m c

e g n a R Acquisition Phantom 0-26 cm Acquisition Phantom 0-35 cm Acquisition Phantom 0-44 cm Acquisition Phantom 0.01-720 cm2 Acquisition Phantom 0.01-96 cm e r u s a e M D 2 y c a r u c c A e g n a R d n a Axial Distance Lateral Distance Diagonal Distance Areac Circumfer-

enced m e t s y S a e c n a r e l o T

< 2% plus 1% of full scale

< 2% plus 1% of full scale

< 2% plus 1% of full scale

< 4% plus

(2% of full scale/smallest dimension) *

100 plus 0.5%

< 3% plus

(1.4% of full scale/

smallest dimension) *

100 plus 0.5%

a. Full scale for distance implies the maximum depth of the image. b. An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. c. The area accuracy is defined using the following equation:

% tolerance = ((1 + lateral error) * (1 + axial error) 1) * 100 +

0.5%. d. The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following equation:

% tolerance = (

2

(maximum of 2 errors) * 100) + 0.5%. Chapter 7: References 139 Table 2: M Mode Measurement and Calculation Accuracy and Range Table 3: PW Doppler Mode Measurement and Calculation Accuracy and Range y B y c a r u c c A d o h t e M t s e T e g n a R e d o M r e l p p o D t n e m e r u s a e M e g n a R d n a y c a r u c c A Acquisition Phantomb 0-26 cm Acquisition Phantomd 0.01-10 sec Acquisition Phantomd 5-923 bpm t n e m e r u s a e M e d o M M e g n a R d n a y c a r u c c A Distance Time Heart Rate e c n a r e l o T m e t s y S

2%

plus 1% of full scalea

2%

plus 1% of full scalec

2%

plus

(Full Scalec *

Heart Rate/1 00) %

a. Full scale for distance implies the maximum depth of the image. b. An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. c. Full scale for time implies the total time displayed on the scrolling graphic image. d. SonoSite special test equipment was used. y B y c a r u c c A t s e T a d o h t e M e g n a R Acquisition Phantom 0.01 cm/sec-

550 cm/s ec Acquisition Phantom 0.01kHz-

20.8 kHz Acquisition Phantom 0.01-10 sec m e t s y S e c n a r e l o T

< +/- 2%

plus 1% of full scaleb

< +/- 2%

plus 1% of full scaleb

< +/- 2%

plus 1% of full scalec Velocity cursor Frequency cursor Time a. SonoSite special test equipment was used. b. Full scale for frequency or velocity implies the total frequency or velocity magnitude, displayed on the scrolling graphic image. c. Full scale for time implies the total time displayed on the scrolling graphic image. Sources of measurement errors Ingeneral,twotypesoferrorscanbeintroduced intothemeasurement:

Acquisition Error Includeserrorsintroducedby theultrasoundsystemelectronicsrelatingto signalacquisition,signalconversion,andsignal processingfordisplay.Additionally, computationalanddisplayerrorsareintroduced bythegenerationofthepixelscalefactor, applicationofthatfactortothecaliperpositions onthescreen,andthemeasurementdisplay. Algorithmic Error Theerrorintroducedby measurements,whichareinputtohigherorder calculations.Thiserrorisassociatedwith 140 Sources of measurement errors R e f e r e n c e s floatingpointversusintegertypemath,whichis subjecttoerrorsintroducedbyroundingversus truncatingresultsfordisplayofagivenlevelof significantdigitinthecalculation. Measurement publications and terminology Thefollowingsectionslistthepublicationsand terminologyusedforeachcalculationresult. Terminologyandmeasurementscomplywith AIUMpublishedstandards. Cardiac references Acceleration (ACC) in cm/s2 Zwiebel,W.J.IntroductiontoVascular Ultrasonography.4thed.,W.B.Saunders Company,(2000),52. ACC=abs(deltavelocity/deltatime) Acceleration Time (AT) in msec Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),219. Aortic Valve Area (AVA) by Continuity Equation in cm2 Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),393,442. A2=A1*V1/V2 where:

A2=Aovalvearea A1=LVOTarea;V1=LVOTvelocity;

V2=Aovalvevelocity LVOT=LeftVentricularOutflow Tract AVA(PVLVOT/PVAO)*CSALVOT AVA(VTILVOT/VTIAO)*CSALVOT Body Surface Area (BSA) in m2 Grossman,W.CardiacCatheterizationand Angiography.Philadelphia:LeaandFebiger,

(1980),90. BSA=0.007184*Weight0.425*Height0.725 Weight=kilograms Height=centimeters Cardiac Index (CI) in l/min/m2 Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2ndEdition,Boston:Little,BrownandCompany,

(1999),59. CI=CO/BSA where:

CO=CardiacOutput BSA=BodySurfaceArea Cardiac Output (CO) in l/min Oh,J.K.,J.B.Seward,A.J.TajikTheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),59. CO=(SV*HR)/1000 where:

CO=CardiacOutput SV=StrokeVolume HR=HeartRate Cross Sectional Area (CSA) in cm2 Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),383. CSA=0.785*D2 where:

D=diameteroftheanatomyof interest Deceleration Time in msec Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),453.

|timeatimeb|

Chapter 7: References 141 Delta Pressure: Delta Time (dP:dT) in mmHg/s Otto,C.M.TextbookofClinicalEchocardiography. 2nded.,W.B.SaundersCompany,(2000),117, 118. 32 mmHg/timeintervalinseconds E:A Ratio in cm/sec E:A=velocityE/velocityA E/Ea Ratio Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),225. EVelocity/Eavelocity where:

Evelocity=MitralValveEvelocity Ea=annularEvelocity,alsoknown as:Eprime Effective Regurgitant Orifice (ERO) in mm2 Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),455. ERO=6.28(r2)*Va/MRVel where:

r=radius Va=aliasingvelocity Ejection Fraction (EF), percent Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),40. EF=((LVEDVLVESV)/LVEDV)*100%

where:

EF=EjectionFraction LVEDV=LeftVentricularEnd DiastolicVolume LVESV=LeftVentricularEnd SystolicVolume Elapsed Time (ET) in msec ET=timebetweenvelocitycursorsin milliseconds Heart Rate (HR) in bpm HR=3digitvalueinputbyuserormeasuredon M ModeandDopplerimageinoneheartcycle Interventricular Septum (IVS) Fractional Thickening, percent Laurenceau,J.L.,M.C.Malergue.TheEssentialsof Echocardiography.LeHague:MartinusNijhoff,

(1981),71. IVSFT=((IVSSIVSD)/IVSD)*100%

where:

IVSS=InterventricularSeptal ThicknessatSystole IVSD=InterventricularSeptal ThicknessatDiastole Isovolumic Relaxation Time (IVRT) in msec Reynolds,Terry.TheEchocardiographersPocket Reference.SchoolofCardiacUltrasound,Arizona HeartInstitute,(1993),146.

|timeatimeb|

Left Atrium/Aorta (LA/Ao) Feigenbaum,H.Echocardiography.Philadelphia:

LeaandFebiger,(1994),206,Figure449. Left Ventricular End Volumes (Teichholz) in ml Teichholz,L.E.,T.Kreulen,M.V.Herman,et.al. Problemsinechocardiographicvolume determinations:echocardiographicangiographic correlationsinthepresenceorabsenceof asynergy.AmericanJournalofCardiology,(1976), 37:7. LVESV=(7.0*LVDS3)/(2.4+LVDS) where:

LVESV=LeftVentricularEnd SystolicVolume 142 Measurement publications and terminology LVDS=LeftVentricularDimension atSystole LVEDV=(7.0*LVDD3)/(2.4+LVDD) where:

LVEDV=LeftVentricularEnd DiastolicVolume LVDD=LeftVentricularDimension atDiastole Left Ventricular Volume: Single Plane Method in ml Schiller,N.B.,P.M.Shah,M.Crawford,et.al. RecommendationsforQuantitationoftheLeft VentriclebyTwoDimensional Echocardiography.JournalofAmericanSocietyof Echocardiography.SeptemberOctober1989,2:362. Left Ventricular Mass in gm Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2ndEdition,Boston:Little,BrownandCompany,

(1999),39. LVMass=1.04[(LVID+PWT+IVST)3LVID3]*

0.8+0.6 where:

LVID=InternalDimension PWT=PosteriorWallThickness IVST=InterventricularSeptal Thickness 1.04=Specificgravityofthe myocardium 0.8=Correctionfactor Left Ventricular Volume: Biplane Method in ml Schiller,N.B.,P.M.Shah,M.Crawford,et.al. RecommendationsforQuantitationoftheLeft VentriclebyTwoDimensional Echocardiography.JournalofAmericanSocietyof Echocardiography.SeptemberOctober1989,2:362. V

4 n 1=

i aibi L

n where:

V=Volumeinml a=Diameter b=Diameter n=Numberofsegments(n=20) L=Length i=Segment R e f e r e n c e s V

4 n 1=

i ai 2 L

n where:

V=Volume a=Diameter n=Numberofsegments(n=20) L=Length i=Segment Left Ventricular Dimension (LVD) Fractional Shortening, percent Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. Boston:Little,BrownandCompany,(1994), 4344. LVDFS=((LVDDLVDS)/LVDD)*100%

where:

LVDD=LeftVentricleDimensionat Diastole LVDS=LeftVentricleDimensionat Systole Left Ventricular Posterior Wall Fractional Thickening (LVPWFT), percent Laurenceau,J.L.,M.C.Malergue.TheEssentialsof Echocardiography.LeHague:MartinusNijhoff,

(1981),71. LVPWFT=((LVPWSLVPWD)/LVPWD)*100%

LVPWS=LeftVentricularPosterior where:

WallThicknessatSystole LVPWD=LeftVentricularPosterior WallThicknessatDiastole Mean Velocity (Vmean) in cm/s Vmean=meanvelocity Chapter 7: References 143 Mitral Valve Area (MVA) in cm2 Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),391,452. MVA=220/PHT where:

Note: 220isanempiricalderivedconstantandmay notaccuratelypredictmitralvalveareainmitral prostheticheartvalves.Themitralvalvearea continuityequationmaybeutilizedinmitral prostheticheartvalvestopredicteffectiveorificearea. PHT=pressurehalftime MV Flow Rate in cc/sec Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),396. Flow=6.28(r2)*Va where:

r=radius Va=aliasingVelocity Pressure Gradient (PGr) in mmHG Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),64. PGr=4*(Velocity)2 PeakEPressureGradient(E PG) E PG=4*PE2 PeakAPressureGradient(A PG) A PG=4*PA2 PeakPressureGradient(PGmax) PGmax=4*PV2 MeanPressureGradient(PGmean) PGmean=Averageofpressure gradients/Durationofflow Pressure Half Time (PHT) in msec Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),391. PHT=DT*0.29 where:

DT=decelerationtime Proximal Isovelocity Surface Area (PISA) in cm2 Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Boston:Little,BrownandCompany,

(1999),125. PISA=2 r2 where:

2 =6.28 r=aliasingradius Qp/Qs Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),400. Qp/Qs=SVQpsite/SVQssite SVsiteswillvarydependinguponthelocationof theshunt. Regurgitant Fraction (RF) in percent Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. Boston:Little,BrownandCompany,(1999),125. RF=RV/MVSV where:

RV=RegurgitantVolume MVSV=MitralStrokeVolume Regurgitant Volume (RV) in cc Reynolds,Terry.TheEchocardiographersPocket Reference.SchoolofCardiacUltrasound,Arizona HeartInstitute,(2000),396,455. RV=ERO*MRVTI 144 Measurement publications and terminology R e f e r e n c e s Right Ventricular Systolic Pressure (RVSP) in mmHg Reynolds,Terry.TheEchocardiographersPocket Reference.SchoolofCardiacUltrasound,Arizona HeartInstitute,(1993),152. RVSP=4*(VmaxTR)2+RAP where:

RAP=RightAtrialPressure S/D Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),217. Svelocity/Dvelocity where:

Svelocity=PulmonaryveinSwave Dvelocity=PulmonaryveinDwave Stroke Index (SI) in cc/m2 MosbysMedical,Nursing,&AlliedHealth Dictionary,4thed.,(1994),1492. SI=SV/BSA where:

SV=StrokeVolume BSA=BodySurfaceArea Stroke Volume (SV) Doppler in ml Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),40,59,62. SV=(CSA*VTI) where CSA=CrossSectionalAreaofthe orifice(LVOTarea) VTI=VelocityTimeIntegralofthe aorticvalve Tricuspid Valve Area (TVA) Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),55,391,452. TVA=220/PHT Stroke Volume (SV) 2D and M Mode in ml Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Boston:Little,BrownandCompany,

(1994),44. SV=(LVEDVLVESV) where:

SV=StrokeVolume LVEDV=EndDiastolicVolume LVEDSV=EndSystolicVolume Velocity Time Integral (VTI) in cm Reynolds,Terry.TheEchocardiographersPocket Reference.2nded.,SchoolofCardiacUltrasound, ArizonaHeartInstitute,(2000),383. VTI=sumofabs(velocities[n]) where:

AutoTracedistance(cm)blood travelswitheachejectionperiod. Velocitiesareabsolutevalues. Obstetrical references Amniotic Fluid Index (AFI) Jeng,C.J.,etal.AmnioticFluidIndex MeasurementwiththeFourQuadrantTechnique DuringPregnancy.TheJournalofReproductive Medicine,35:7(July1990),674677. Average Ultrasound Age (AUA) ThesystemprovidesanAUAderivedfromthe componentmeasurementsfromthe measurementtables. Estimated Date of Delivery (EDD) by Average Ultrasound Age (AUA) Resultsaredisplayedasmonth/day/year. EDD=systemdate+(280daysAUAindays) Estimated Date of Delivery (EDD) by Last Menstrual Period (LMP) Thedateenteredintothepatientinformationfor LMPmustprecedethecurrentdate. Resultsaredisplayedasmonth/day/year. Chapter 7: References 145 EDD=LMPdate+280days Estimated Fetal Weight (EFW) Hadlock,F.,etal.EstimationofFetalWeight withtheUseofHead,Body,andFemur Measurements,AProspectiveStudy.American JournalofObstetricsandGynecology,151:3

(February1,1985),333337. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),154. OsakaUniversity.UltrasoundinObstetricsand Gynecology.(July 20,1990),103105. ShepardM.J.,V.A.Richards,R.L.Berkowitz,et al.AnEvaluationofTwoEquationsfor PredictingFetalWeightbyUltrasound. AmericanJournalofObstetricsandGynecology,142:1

(January1,1982),4754. UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),880,Equation1. Gestational Age (GA) by Last Menstrual Period (LMP) ThegestationalagederivedfromtheLMPdate enteredonthepatientinformationform. Resultsaredisplayedinweeksanddays,andis calculatedasfollows:

GA(LMP)=SystemdateLMPdate Gestational Age (GA) by Last Menstrual Period (LMPd) Derived from Established Due Date (Estab. DD) SameasGAbyEstab. DD. Thegestationalagederivedfromthesystem derivedLMPusingtheEstablishedDueDate enteredonthepatientinformationform. Resultsaredisplayedinweeksanddays,andis calculatedasfollows:

GA(LMPd)=SystemDateLMPd Last Menstrual Period Derived (LMPd) by Established Due Date (Estab. DD) Resultsaredisplayedasmonth/day/year. LMPd(Estab. DD)=Estab. DD280days Gestational age tables Abdominal Circumference (AC) Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),431. UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),885. WARNING:

The gestational age calculated by your SonoSite system does not match the age in the aforementioned reference at the 20.0 cm and 30.0 cm abdominal circumference (AC) measurements. The implemented algorithm extrapolates the gestational age from the slope of the curve of all table measurements, rather than decreasing the gestational age for a larger AC measurement indicated in the referenced table. This results in the gestational age always increasing with an increase in AC. Anteroposterior Trunk Diameter (APTD) UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),885. 146 Measurement publications and terminology R e f e r e n c e s Biparietal Diameter (BPD) Chitty,L.S.andD.G.Altman.Newchartsfor ultrasounddatingofpregnancy.Ultrasoundin ObstetricsandGynecology10:(1997),174179, Table3. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),440. OsakaUniversity.UltrasoundinObstetricsand Gynecology.(July 20,1990),98. UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),885. Crown Rump Length (CRL) Hadlock,F.,etal.FetalCrownRumpLength:

ReevaluationofRelationtoMenstrualAge(518 weeks)withHighResolution,RealTime Ultrasound.Radiology,182:(February1992), 501505. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),439. OsakaUniversity.UltrasoundinObstetricsand Gynecology.(July20,1990),20and96. TokyoUniversity.GestationalWeeksand ComputationMethods.UltrasoundImaging Diagnostics,12:1(19821),2425,Table3. Femur Length (FL) Chitty,L.S.andD.G.Altman.Newchartsfor ultrasounddatingofpregnancy.Ultrasoundin ObstetricsandGynecology10:(1997),174179, Table8,186. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),431. OsakaUniversity.UltrasoundinObstetricsand Gynecology.(July 20,1990),101102. UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),886. Fetal Trunk Cross-Sectional Area (FTA) OsakaUniversity.UltrasoundinObstetricsand Gynecology.(July 20,1990),99100. Gestational Sac (GS) Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986). Nyberg,D.A.,etal.TransvaginalUltrasound. MosbyYearbook,(1992),76. Gestationalsacmeasurementsprovideafetal agebasedonthemeanofone,two,orthree distancemeasurements;however,Nybergs gestationalageequationrequiresallthree distancemeasurementsforanaccurate estimate. TokyoUniversity.GestationalWeeksand ComputationMethods.UltrasoundImaging Diagnostics,12:1(19821). Head Circumference (HC) Chitty,L.S.andD.G.Altman.Newchartsfor ultrasounddatingofpregnancy.Ultrasoundin ObstetricsandGynecology10:(1997),174191, Table5,182. Chapter 7: References 147 Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),431. Occipito-Frontal Diameter (OFD) Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),431. Transverse Trunk Diameter (TTD) Hansmann,M.,etal.UltrasoundDiagnosisin ObstetricsandGynecology.NewYork:

SpringerVerlag,(1986),431. UniversityofTokyo,Shinozuka,N.FJSUM,etal. StandardValuesofUltrasonographicFetal Biometry.JapaneseJournalofMedicalUltrasonics, 23:12(1996),885. Growth analysis tables Abdominal Circumference (AC) Chitty,LynS.etal.ChartsofFetalSize:3. AbdominalMeasurements.BritishJournalof ObstetricsandGynaecology101:(February1994), 131,Appendix:ACDerived. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. JeantyP.,E.Cousaert,andF.Cantraine.Normal GrowthoftheAbdominalPerimeter.American JournalofPerinatology,1:(January1984),129135.

(AlsopublishedinHansmann,Hackeloer, Staudach,Wittman.UltrasoundDiagnosisin ObstetricsandGynecology.SpringerVerlag, NewYork,(1986),179,Table7.13.) Biparietal Diameter (BPD) Chitty,LynS.etal.ChartsofFetalSize:2.Head Measurements.BritishJournalofObstetricsand Gynaecology101:(January1994),43,Appendix:

BPDOuterInner. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. JeantyP.,E.Cousaert,andF.Cantraine.A LongitudinalStudyofFetalLimbGrowth. AmericanJournalofPerinatology,1:(January1984), 136144,Table5.

(AlsopublishedinHansmann,Hackeloer, Staudach,Wittman.UltrasoundDiagnosisin ObstetricsandGynecology.SpringerVerlag, NewYork,(1986),176,Table7.8.) Estimated Fetal Weight (EFW) HadlockF.,etal.InUteroAnalysisofFetal Growth:ASonographicWeightStandard. Radiology,181:(1991),129133. Jeanty,Philippe,F.Cantraine,R.Romero,E. Cousaert,andJ.Hobbins.ALongitudinalStudy ofFetalWeightGrowth.JournalofUltrasoundin Medicine,3:(July1984),321328,Table1.

(AlsopublishedinHansmann,Hackeloer, Staudach,andWittman.UltrasoundDiagnosis inObstetricsandGynecology.SpringerVerlag, NewYork,(1986),186,Table7.20.) Femur Length (FL) Chitty,LynS.etal.ChartsofFetalSize:4.Femur Length.BritishJournalofObstetricsand Gynaecology101:(February1994),135. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. 148 Measurement publications and terminology JeantyP,E.Cousaert,andF.Cantraine.A LongitudinalStudyofFetalLimbGrowth. AmericanJournalofPerinatology,1:(January1984), 136144,Table5.

(AlsopublishedinHansmann,Hackeloer, Staudach,Wittman.UltrasoundDiagnosisin ObstetricsandGynecology.SpringerVerlag, NewYork,(1986),182,Table7.17.) Head Circumference (HC) Chitty,LynS.,etal.ChartsofFetalSize:2.Head Measurements.BritishJournalofObstetricsand Gynaecology101:(January1994),43,Appendix:

HCDerived. Hadlock,F.,etal.EstimatingFetalAge:

ComputerAssistedAnalysisofMultipleFetal GrowthParameters.Radiology,152:(1984), 497501. JeantyP,E.Cousaert,andF.Cantraine.A longitudinalstudyofFetalHeadBiometry. AmericanJofPerinatology,1:(January1984), 118128,Table3.

(AlsopublishedinHansmann,Hackeloer, Staudach,Wittman.UltrasoundDiagnosisin ObstetricsandGynecology.SpringerVerlag, NewYork,(1986),176,Table7.8.) Head Circumference (HC)/Abdominal Circumference (AC) CampbellS.,ThomsAlison.Ultrasound MeasurementsoftheFetalHeadtoAbdomen CircumferenceRatiointheAssessmentof GrowthRetardation,BritishJournalofObstetrics andGynaecology,84:(March1977),165174. Ratio calculations FL/AC Ratio HadlockF.P.,R.L.Deter,R.B.Harrist,E.Roecker, andS.K.Park.ADateIndependentPredictorof IntrauterineGrowthRetardation:Femur Length/AbdominalCircumferenceRatio, AmericanJournalofRoentgenology,141:(November 1983),979984. FL/BPD Ratio Hohler,C.W.,andT.A.Quetel.Comparisonof UltrasoundFemurLengthandBiparietal DiameterinLatePregnancy,AmericanJournalof ObstetricsandGynecology,141:7(Dec.11981), 759762. FL/HC Ratio HadlockF.P.,R.B.Harrist,Y.Shah,andS.K.Park. TheFemurLength/HeadCircumference RelationinObstetricSonography.Journalof UltrasoundinMedicine,3:(October1984),439442. HC/AC Ratio CampbellS.,ThomsAlison.Ultrasound MeasurementsoftheFetalHeadtoAbdomen CircumferenceRatiointheAssessmentof GrowthRetardation,BritishJournalofObstetrics andGynaecology,84:(March1977),165174. R e f e r e n c e s General references

+/x or S/D Ratio

+/x=abs(VelocityA/VelocityB) A=velocitycursor+

where B=velocitycursorx Acceleration Index (ACC) Zwiebel,W.J.IntroductiontoVascular Ultrasonography,4thed.,W.B.Saunders Company,(2000),52. ACC=abs(deltavelocity/deltatime) Elapsed Time (ET) ET=timebetweenvelocitycursorsin milliseconds Chapter 7: References 149 Hip Angle/d:D Ratio Graf,R.FundamentalsofSonographic DiagnosisofInfantHipDysplasia.Journalof PediatricOrthopedics,Vol.4,No.6:735740,1984. Morin,C.,Harcke,H.,MacEwen,G.TheInfant Hip:RealTimeUSAssessmentofAcetabular Development.Radiology177:673677,December 1985. Intima Media Thickness (IMT) HowardG,SharrettAR,HeissG,EvansGW, ChamblessLE,RileyWA,etal.CarotidArtery IntimaMedialThicknessDistributioninGeneral PopulationsAsEvaluatedbyBMode Ultrasound.ARICInvestigators. AtherosclerosisRiskinCommunities.Stroke.

(1993),24:12971304. OLeary,DanielH.,MDandPolak,Joseph,F., MD,etal.UseofSonographytoEvaluate CarotidAtherosclerosisintheElderly.The CardiovascularHealthStudy.Stroke.(September 1991),22,11551163. Redberg,RitaF.,MDandVogel,RobertA.,MD, etal.Taskforce#3WhatistheSpectrumof CurrentandEmergingTechniquesforthe NoninvasiveMeasurementofAtherosclerosis?

JournaloftheAmericanCollegeofCardiology.(June 4,2003),41:11,18861898. Percent Area Reduction TaylorK.J.W.,P.N.Burns,P.Breslau.Clinical ApplicationsofDopplerUltrasound,RavenPress, N.Y.,(1988),130136. ZwiebelW.J.,J.A.Zagzebski,A.B.Crummy,etal. CorrelationofpeakDopplerfrequencywith lumennarrowingincarotidstenosis.Stroke,3:

(1982),386391.

%AreaReduction=(1A2(cm2)/A1(cm2))*100 A1=originalareaofthevesselin where:

squarecm A2=reducedareaofthevesselin squarecm Percent Diameter Reduction Handa,Nobuoetal.,EchoDopplerVelocimeter intheDiagnosisofHypertensivePatients:The RenalArteryDopplerTechnique,Ultrasoundin MedicineandBiology,12:12(1986),945952.

%DiameterReduction=(1D2(cm)/D1(cm))*

100 where:

D1=originaldiameterofthevessel incm D2=reduceddiameterofthevessel incm Pressure Gradient (PGr) in mmHG Oh,J.K.,J.B.Seward,A.J.Tajik.TheEchoManual. 2nded.,Lippincott,Williams,andWilkins,

(1999),64. 4*(Velocity)2 PeakEPressureGradient(E PG) E PG=4*PE2 PeakAPressureGradient(A PG) A PG=4*PA2 PeakPressureGradient(PGmax) PGmax=4*PV2 MeanPressureGradient(PGmean) PGmean=4*Vmax2 Pulsatility Index (PI) Kurtz,A.B.,W.D.Middleton.Ultrasoundthe Requisites.MosbyYearBook,Inc.,(1996),469. PI=(PSVEDV)/V where PSV=peaksystolicvelocity EDV=enddiastolicvelocity V=meanflowvelocitythroughout theentirecardiaccycle Resistive Index (RI) Kurtz,A.B.,W.D.Middleton.Ultrasoundthe Requisites.MosbyYearBook,Inc.,(1996),467. 150 Measurement publications and terminology RI=abs((VelocityAVelocityB)/VelocityA)in measurements where A=velocitycursor+

B=velocitycursorx Time Averaged Mean (TAM) in cm/s TAM=mean(meanTrace) Volume (Vol) Beyer,W.H.StandardMathematicalTables,28thed., CRCPress,BocaRaton,FL,(1987),131. Volume Flow (VF) in l/m Allan,PaulL.etal.ClinicalDopplerUltrasound, 4thed.,HarcourtPublishersLimited.(2000), 3638. VF=CSA*TAM* .06 R e f e r e n c e s Chapter 7: References 151 152 Measurement publications and terminology Chapter 8: Specifications Thischaptercontainssystemandaccessory specificationsandstandards.Thespecifications forrecommendedperipheralsareinthe manufacturersinstructions. Dimensions System Length:11.8in.(29.97cm) Width:10.8in.(27.43cm) Height:3.1in.(7.87cm) Weight:8.5lbs.(3.9kg)withtheC60xtransducer andbatteryinstalled Display Length:8.4in.(21.34cm) Height:6.3in.(16cm) Diagonal:10.4in.(26.4cm) Supported transducers C11x/85MHz(6ft/1.8m) C60x/52MHz(5.5ft/1.7m) D2x/2MHz(5.5ft/1.7m) HFL38x/136MHz(5.6ft/1.7m) ICTx/85MHz(5.5ft/1.7m) L25x/136MHz(7.5ft/2.3m) L38x/105MHz(5.5ft/1.7m) P10x/84MHz(6ft/1.8m) P21x/51MHz(6ft/1.8m) SLAx/136MHz(7.5ft/2.3m) TEEx/83MHz(7.2ft./2.2m) S p e c i f i c a t i o n s Imaging modes 2D(256grayshades) ColorpowerDoppler(CPD)(256colors) ColorDoppler(Color)(256colors) M Mode Pulsedwave(PW)Doppler Continuouswave(CW)Doppler TissueDopplerImaging(TDI) TissueHarmonicImaging(THI) Image and clip storage Internalstorage:Thenumberofimagesandclips youcansavedependsonimagingmodeandfile format. Accessories Thefollowingitemsareeitherincludedwithor availableforuseontheultrasoundsystem:

Battery BiopsyGuide Carrycase ECGcable(6ft/1.8m) Educationkeys Externaldisplay Footswitch MiniDock MobileDockingSystemMSeries(MDSm) MobileDockingSystemLiteII(MDSLiteII) NeedleGuide Chapter 8: Specifications 153 Powersupply SiteLinkImageManager SonoCalcIMT SystemACpowercord(10ft/3.1m) TripleTransducerConnect Peripherals Seethemanufacturersspecificationsforthe followingperipherals. Medical grade Barcodescanner,serial Barcodescanner,USB Blackandwhiteprinter Recommendedsourcesforprinterpaper:

ContactSonyat8006867669or www.sony.com/professionaltoordersupplies ortofindthelocaldistributor. Colorprinter DVDrecorder Non-medical grade Kensingtonsecuritycable USBstoragedevice Temperature and humidity limits Note: Thetemperature,pressure,andhumiditylimits applyonlytotheultrasoundsystem,transducers,and battery. Operating System, battery, and transducer 1040C(50104F),1595%R.H. 700to1060hPa(0.7to1.05ATM) Shipping and storage System and transducer 3565C(31149F),1595%R.H. 500to1060hPa(0.5to1.05ATM) Battery 2060C(4140F),1595%R.H.(Forstorage longerthan30days,storeatorbelowroom temperature.) 500to1060hPa(0.5to1.05ATM) Electrical PowerSupplyInput:100240VAC,50/60Hz,2.0 AMax@100VAC PowerSupplyOutput#1:15VDC,5.0AMax PowerSupplyOutput#2:12VDC,2.3AMax Battery Thebatterycomprisessixlithiumioncellsplus electronics,atemperaturesensor,andbattery contacts. Runtimeisuptotwo hours,dependingon imagingmodeanddisplaybrightness. Electromechanical safety standards EN606011:1997,EuropeanNorm,Medical ElectricalEquipmentPart 1.General RequirementsforSafety. EN6060111:2001,EuropeanNorm,Medical ElectricalEquipmentPart1.General RequirementsforSafetySection11.Collateral Standard.SafetyRequirementsforMedical ElectricalSystems. 154 Temperature and humidity limits Airborne equipment standards RTCA/DO160E:2004,RadioTechnical CommissionforAeronautics,Environmental ConditionsandTestProceduresforAirborne Equipment,Section 21.0EmissionofRadio FrequencyEnergy,Category B. DICOM standard NEMAPS 3.15:2000,DigitalImagingand CommunicationsinMedicine(DICOM)Part15:

SecurityProfiles. HIPAA standard TheHealthInsuranceandPortabilityand AccountabilityAct,Pub.L.No.104191(1996). 45CFR160,GeneralAdministrative Requirements. 45CFR164,SecurityandPrivacy. S p e c i f i c a t i o n s EN60601237:2001+AmendmentA1:2005, EuropeanNorm,Particularrequirementsforthe safetyofultrasonicmedicaldiagnosticand monitoringequipment. CAN/CSAC22.2,No.601.1M90,Canadian StandardsAssociation,MedicalElectrical EquipmentPart1.GeneralRequirementsfor Safety(includingCSA601.1Supplement1:1994 andCSA601.1Amendment2:1998). CEI/IEC61157:1992,International ElectrotechnicalCommission,Requirementsfor theDeclarationoftheAcousticOutputof MedicalDiagnosticUltrasonicEquipment. UL606011(1stEdition),Underwriters Laboratories,MedicalElectrical EquipmentPart 1:GeneralRequirementsfor Safety. EMC standards classification EN6060112:2007,EuropeanNorm,Medical ElectricalEquipment.GeneralRequirementsfor SafetyCollateralStandard.Electromagnetic Compatibility.RequirementsandTests. CISPR11:2004,InternationalElectrotechnical Commission,InternationalSpecialCommitteeon RadioInterference.Industrial,Scientific,and Medical(ISM)RadioFrequencyEquipment ElectromagneticDisturbance CharacteristicsLimitsandMethodsof Measurement. TheClassificationfortheultrasoundsystem, dockingsystem,accessories,andperipherals whenconfiguredtogetheris:Group1,ClassA. Chapter 8: Specifications 155 156 HIPAA standard Glossary Terms Forultrasoundtermsnotincludedinthisglossary,refertoRecommendedUltrasound Terminology,SecondEdition,publishedin1997bytheAmericanInstituteofUltrasoundin Medicine(AIUM). as low as reasonably achievable (ALARA) The guiding principle of ultrasound use, which states that you should keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results. curved array transducer depth in situ LCD linear array transducer Identified by the letter C (curved or curvilinear) and a number (60). The number corresponds to the radius of curvature of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, C15, C60e. Refers to the depth of the display. A constant speed of sound of 1538.5 meters/second is assumed in the calculation of echo position in the image. In the natural or original position. liquid crystal display Identified by the letter L (linear) and a number (38). The number corresponds to the radius of width of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, L38. l G o s s a r y mechanical index

(MI) An indication of the likelihood of mechanical bioeffects occurring: the higher the MI, the greater the likelihood of mechanical bioeffects. See Chapter 6, Safety, for a more complete description of MI. MI/TI NTSC PAL See mechanical index (MI) and thermal index (TI). National Television Standards Committee. A video format setting. See also PAL. Phase Alternating Line. A video format setting. See also NTSC. phased array A transducer designed primarily for cardiac scanning. Forms a sector image by electronically steering the beam direction and focus. Glossary 157 skinline SonoHD SonoMB Tissue Doppler Imaging (TDI) thermal index (TI) A depth on the display that corresponds to the skin/transducer interface. A subset of the 2D imaging mode in which the 2D image is enhanced by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image. A subset of the 2D imaging mode in which the 2D image is enhanced by looking at a target from multiple angles and then merging or averaging the scanned data together to improve overall image quality and, in parallel, reducing noise and artifacts. A pulsed wave Doppler technique used to detect myocardial motion. The ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1C under defined assumptions. See Chapter 6, Safety, for a more complete description of TI. TIB (bone thermal index) A thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIC (cranial bone thermal index) A thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body. TIS (soft tissue thermal index) A thermal index related to soft tissues. Tissue Harmonic Imaging Transmits at one frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution. transducer variance A device that transforms one form of energy into another form of energy. Ultrasound transducers contain piezoelectric elements, which when excited electrically, emit acoustic energy. When the acoustic energy is transmitted into the body, it travels until it encounters an interface, or change in tissue properties. At the interface, an echo is formed that returns to the transducer, where this acoustic energy is transformed into electrical energy, processed, and displayed as anatomical information. Displays a variation in Color Doppler flow imaging within a given sample. Variance is mapped to the color green and is used to detect turbulence. 158 Abbreviations Abbreviations in User Interface Abbreviation Definition

A A PG A2Cd A2Cs A4Cd A4Cs AAA AAo Abd abs AC ACA ACC ACoA ACS Adur AFI AI AI PHT AL Ann D ANT F ANT N

+ Caliper/ Caliper Ratio A Wave Peak Velocity A Wave Peak Pressure Gradient Apical 2 Chamber diastolic Apical 2 Chamber systolic Apical 4 Chamber diastolic Apical 4 Chamber systolic Abdominal Aortic Aneurysm Ascending Aorta Abdomen Absolute value Abdominal Circumference Anterior Cerebral Artery Acceleration Index Anterior Communicating Artery Aortic Valve Cusp Separation A wave duration Amniotic Fluid Index Aortic Insufficiency Aortic Insufficiency Pressure Half Time Atlas Loop Annulus Diameter Anterior Far Anterior Near l G o s s a r y Glossary 159 Abbreviations in User Interface (Continued) Abbreviation Definition Aorta Aortic Root Diameter Apical View Anteroposterior Trunk Diameter Acceleration (Deceleration) Time Average Ultrasound Age Calculated by averaging the individual ultrasound ages for the fetal biometry measurements performed during the exam. The measurements used to determine the AUA are based on the selected OB calculation authors. Aortic Valve Aortic Valve Area Aortic Valve Area Basilar Artery Bifurcation Blood Pressure Biparietal Diameter Beats per Minute Breast Body Surface Area Common Carotid Artery Cardiac Index Cardiac Output Color Power Doppler Cardiac Crown Rump Length Continuous Wave Doppler Ao AoD Apical APTD AT AUA AV AV Area AVA BA Bifur BP BPD BPM Bre BSA CCA CI CO CPD Crd CRL CW 160 Abbreviations in User Interface (Continued) Abbreviation Definition Cx L D D Apical DCCA DECA DICA Dist dP:dT E E PG E:A E/e ECA ECG ECICA ECVA EDD EDD by AUA EDD by LMP EDV EF Cervix Length Diameter Distance Apical Distal Common Carotid Artery Distal External Carotid Artery Distal Internal Carotid Artery Distal Delta Pressure: Delta Time E Wave Peak Velocity E Wave Peak Pressure Gradient E:A Ratio l G o s s a r y E velocity = Mitral Valve E velocity divided by the annular e velocity External Carotid Artery Electrocardiogram Extracranial Internal Carotid Artery Extracranial Vertebral Artery Estimated Date of Delivery Estimated Date of Delivery by Average Ultrasound Age The estimated date of delivery calculated from the measurements performed during the exam. Estimated Date of Delivery by Last Menstrual Period The due date calculated from the user-entered LMP. End Diastolic Velocity Ejection Fraction EF:SLOPE E-F Slope Glossary 161 Abbreviations in User Interface (Continued) Abbreviation Definition EFW Endo Epi EPSS Estab. DD ET FH FHR FL Estimated Fetal Weight Calculated from the measurements performed during the exam. The measurements used to determine EFW are defined by the currently selected EFW calculation author. Endocardial Epicardial E Point Septal Separation Established Due Date A user-entered due date based on previous exam data or other available information. The LMP is derived from the Established Due Date and is listed in the patient report as LMPd. Elapsed Time Femoral Head Fetal Heart Rate Femur Length FM (Right and Left) Foramen Magnum (same as SO) Fetal Trunk Area Gestational Age Gestational Age by Last Menstrual Period The fetal age calculated using the date of the Last Menstrual Period

(LMP). Gestational Age by derived Last Menstrual Period The fetal age calculated using the Last Menstrual Period (LMPd) derived from the Estab. DD. Depth of Doppler Gate Gestational Sac Gynecology Head Circumference Heart Rate FTA GA GA by LMP GA by LMPd Gate GS Gyn HC HR 162 Abbreviations in User Interface (Continued) Abbreviation Definition ICA IMT IVRT IVS IVSd IVSFT IVSs LA LA/Ao LAT F LAT N LMP LMP LMPd LV LV Area LV mass Internal Carotid Artery Intima Media Thickness Iso Volumic Relaxation Time Interventricular Septum Interventricular Septum Diastolic Interventricular Septum Fractional Thickening Interventricular Septum Systolic Left Atrium Left Atrium/Aorta Ratio Lateral Far Lateral Near Last Menstrual Period Last Menstrual Period The first day of the last menstrual period. Used to calculate gestational age and EDD. derived Last Menstrual Period Calculated from the user-entered Estab. DD. l G o s s a r y Left Ventricular Left Ventricular Area Left Ventricular mass LV Volume Left Ventricular Volume LVd LVD LVDd LVDFS LVDs Left Ventricular diastolic Left Ventricular Dimension Left Ventricular Dimension Diastolic Left Ventricular Dimension Fractional Shortening Left Ventricular Dimension Systolic Glossary 163 Abbreviations in User Interface (Continued) Abbreviation Definition Left Ventricular End Diastolic Volume Left Ventricular End Systolic Volume Left Ventricular Ejection Time Left Ventricular Opacification Left Ventricular Outflow Tract Left Ventricular Outflow Tract Area Left Ventricular Outflow Tract Diameter Left Ventricular Outflow Tract Velocity Time Integral Left Ventricular Posterior Wall Left Ventricular Posterior Wall Diastolic Left Ventricular Posterior Wall Fractional Thickening Left Ventricular Posterior Wall Systolic Left Ventricular systolic SonoMB Middle Cerebral Artery Mid Common Carotid Artery Mid External Carotid Artery Mechanical Index Mid Internal Carotid Artery Middle M Mode Mitral Regurgitation Proximal Iso Velocity Surface Area Mitral Regurgitation/Velocity Time Integral Muscle Mitral Valve LVEDV LVESV LVET LVO LVOT LVOT Area LVOT D LVOT VTI LVPW LVPWd LVPWFT LVPWs LVs MB MCA MCCA MECA MI MICA Mid MM MR PISA MR/VTI Msk MV 164 Abbreviations in User Interface (Continued) Abbreviation Definition MV Area Mitral Valve Area MV Regurgitant Fraction Mitral Valve Regurgitant Fraction MV Regurgitant Volume Mitral Valve Regurgitant Volume MV/VTI MVA MV ERO Mitral Valve/Velocity Time Integral Mitral Valve Area Mitral Valve Effective Regurgitant Orifice MV PISA Area Mitral Valve Proximal Iso Velocity Surface Area MV Rate Mitral Valve Rate Neo Nrv NST NTSC OA OB OFD Oph Orb PAL PCAp PCCA PCoA PECA PGmax PGmean PGr Neonatal Nerve Non-stress test National Television Standards Committee Ophthalmic Artery Obstetrical Occipital Frontal Diameter Ophthalmic Orbital Phase Alternating Line Posterior Cerebral Artery Peak Proximal Common Carotid Artery Posterior Communicating Artery Proximal External Carotid Artery Maximum Pressure Gradient Mean Pressure Gradient Pressure Gradient l G o s s a r y Glossary 165 Abbreviations in User Interface (Continued) Abbreviation Definition Pressure Half Time Pulsatility Index Proximal Internal Carotid Artery Proximal Isovelocity Surface Area Plaque Posterior Far Posterior Near Pulse Repetition Frequency Proximal Peak Systolic Velocity Pulmonic Valve Pulmonary Vein Pulsed Wave Doppler Pulmonary blood flow divided by systemic blood flow Right Atrial (pressure) Resistive Index Right Ventricular Dimension Right Ventricular Dimension Diastolic Right Ventricular Dimension Systolic Right Ventricular Outflow Tract Diameter Right Ventricular Outflow Tract Velocity Time Integral Right Ventricular Systolic Pressure Right Ventricular Free Wall Right Ventricular Free Wall Diastolic Right Ventricular Free Wall Systolic PHT PI PICA PISA Plaq POST F POST N PRF Prox PSV PV P. Vein PW Qp/Qs RA RI RVD RVDd RVDs RVOT D RVOT VTI RVSP RVW RVWd RVWs 166 Abbreviations in User Interface (Continued) Abbreviation S S/D SI Definition SonoHD Systolic/Diastolic Ratio Stroke Index Siphon Siphon (internal carotid artery) SM SmP SO Sup SV TAM TAP TCD TDI THI TI TICA TO Submandibular Small Parts Suboccipital Superficial Stroke Volume Time Average Mean Time Average Peak Transcranial Doppler Tissue Doppler Imaging Tissue Harmonic Imaging Thermal Index Terminal Internal Carotid Artery Transorbital TRmax Tricuspid Regurgitation (peak velocity) TT TTD TV TVA UA Transtemporal Transverse Trunk Diameter Tricuspid Valve Tricuspid Valve Area Ultrasound Age Calculated on the mean measurements taken for a particular fetal biometry. Umb A Umbilical Artery Glossary 167 l G o s s a r y Abbreviations in User Interface (Continued) Abbreviation Definition VA VArty Vas Ven VF Vmax Vmean Vol VTI YS Vertebral Artery Vertebral Artery Vascular Venous Volume Flow Peak Velocity Mean Velocity Volume Velocity Time Integral Yolk Sac 168 Index Symbols

+/x measurement 44 Numerics 2D imaging 25 2D options 25 A A & B shortcut keys 15 abbreviations 159 abdominal, intended uses 12 AC power indicator 6 acceleration (ACC) index 44 accessories list 153 acoustic measurement precision 133 acoustic output measurement 105 tables 107, 132 acquisition error 140 add new user 16 Administrator 16 age, gestational 62 airborne equipment standards 155 ALARA principle 97, 98, 157 alphanumeric keys 5 angle correction 28, 29 annotations keys 5 place 32 predefine label groups 18 setup 18 aorta (Ao) 53 aortic valve area (AVA) 56 arrow graphic 33 ascending aorta (AAo) 53 audio 19 B bar code scanner 19 baseline 29 battery clean 75 safety 90 setup 19 specifications 154 beeps 19 biological safety 92 biopsy 26 bodymarker. See pictographs brightness 26 C cables clean and disinfect ECG 76 connect power 3 calculations cardiac. See cardiac calculations delete measurement 46 general 45 gynecology (Gyn) 58 IMT 59 menu 7, 45 OB 61 percent area 47 percent diameter 47 percent reduction 46 perform measurement 45 performing 45 repeat measurement 46 save 45 small parts 64 specialized 50 vascular 67 view measurement 46 volume 48 volume flow 48, 49 calipers 41 cardiac calculations AAo 53 Ao 53 AVA 56 CI 57 CO 57 dP:dT 56 HR 57 IVRT 52 LA 53 LV volume (Simpsons Rule) 53 I n d e x Index 169 LVd 53 LVOT D 53 LVs 53 MV/AV area 54 overview 50 PHT 55 PISA 51 RVSP 55 setup 19 SV 57 TDI 58 VTI 54 cardiac index (CI) 57 cardiac output (CO) 57 cardiac references 141 cardiac, intended uses 12 cautions, definition vii cine buffer 5, 30 clean battery 75 ECG cable 76 footswitch 75 LCD screen 73 system 73 transducers 74 clip acquisition delay 39 clips See also images and clips options 26, 35 color Doppler (Color) imaging 27 color power Doppler (CPD) imaging 27 color scheme, background 23 color suppress 27 Color. See color Doppler (Color) imaging connectivity setup, wireless certificates 19 continuous wave (CW) Doppler imaging 28, 29 controls direct 98 indirect 99 receiver 99 CPD. See color power Doppler (CPD) imaging customer assistance vii CW Doppler. See continuous wave (CW) Doppler imaging D date 20 default settings 15 delta pressure:delta time (dP:dT) 56 depth adjust 30 definition 157 keys 5 marker 7 DICOM standard 155 disinfect battery 75 ECG cable 76 system 73 transducers 74 disinfectants, compatibility 77 display setup 20 distance measurements 2D 42 M mode 43 D-line 28 Doppler Doppler gate depth 29 measurements 43 scale setup 22 dual images 25 duplex 22 DVD recorder 19, 71 Dynamic Range 22 E ECG Monitoring 26, 38 elapsed time (ET) measurement 44 electrical safety 88 specifications 154 electromagnetic compatibility 93 electromechanical safety standards 154 EMC classification standards 155 EMED worksheets 70 equipment safety 90 error message 89 errors acquisition 140 algorithmic 140 measurement 140 estimated date of delivery (EDD) 145 estimated fetal weight (EFW) 146 Event log 17 exam change type 31 end 34 170 Index type and transducer 31 export and import OB calculation tables 21 predefined label groups 18 user accounts 17 F far 5 fetal heart rate (FHR) 63 flow sensitivity 27 focal zones, optimize 25 footswitch setup 15 forms 6 freeze 30 G gain adjust 30 ECG 39 knob 5 gate size 29 gestational age setup 21 tables, references 146 gestational growth, measure 63 grace period 71 grayscale 25 growth analysis setup 21 tables, references 148 guidance documents, related 104 guideline 26 gynecology, intended uses 12 H heart rate 34 heart rate (HR) 43, 57, 63 HIPAA standard 155 home position 33 humidity limits 154 I image quality, poor 71 images and clips archive 38 delete 38 export to USB 38 review 37 imaging modes list of 153 transducer 31 import. See export and import IMT. See Intima Media Thickness (IMT) in situ, definition 157 infertility, intended uses 12 intended uses 1113 intensity derated 105 in situ 105 water-value 105 interventional, intended uses 12 Intima Media Thickness (IMT) calculations 20, 59 sketch 61 trace 61 intraoperative, intended uses 12 invert Color 28 spectral trace 29 iso volumic relaxation time (IVRT) 52 K keys 5 knobs 5 L labeling symbols 134 language 23 layout 22 LCD screen clean 73 output 103 left atrium (LA) 53 left ventricular diastolic (LVd) 53 left ventricular outflow tract diameter (LVOT D) 53 left ventricular systolic (LVs) 53 left ventricular volume (LV volume) 53 license key 71 live trace 22, 30 login Administrator 16 user 16 LVO (Left Ventricular Opacification) 26 Index 171 I n d e x M M Mode imaging 26 maintenance 72 measurements

+/x Ratio, Doppler 44 See also calculations 2D 42 about 41 Acceleration, Doppler 44 accuracy 41, 139 area, 2D 42 automatic trace, Doppler 44 circumference, 2D 42 delete 41 distance, 2D 42 distance, M Mode 43 Doppler 43 edit 41 Elapsed Time, Doppler 44 errors 140 fetal heart rate 63 heart rate 43, 63 M Mode 43 manual trace 42, 44 Pressure Gradient, Doppler 43 publications 141 Resistive Index, Doppler 44 save to calculation and report 41 terminology 141 vascular 67 Velocities, Doppler 44 mechanical index (MI) 103, 157 mitral valve/aortic valve (MV/AV) 54 M-line 26 mode data 7, 20 modes, keys 6 N near 5 network 20 NTSC definition 157 option 19 O OB calculations 20, 61 custom measurements setup 21 custom tables setup 22 graphs 70 intended uses 12 references 145 tables setup 22 on-screen controls 6 optimize 25 orientation marker 7 option 26 output display 103 P PAL definition 157 option 19 password 16, 17, 18 patient header 7, 20 patient information form 33, 36, 37 patient list 36 patient report about 68 cardiac 69 general 68 OB 69 save measurement to 41 vascular 69 PC 19 pediatric, intended uses 12 percent reduction calculation 46 peripherals 154 pictographs PICTO key 7 placing 33 power delay 19 power key 5 precision, acoustic measurement 133 preferences 22 presets 22 pressure half time (PHT) 55 pressure limits 154 PRF 28, 29 print 37 printer problem 71 setup 19 probe. See transducer proximal isovelocity surface area (PISA) 51 pulsed wave (PW) Doppler imaging 28 172 Index PW Doppler. See pulsed wave (PW) Doppler imaging R recording problem 71 references cardiac 141 general 149 gestational age tables 146 growth analysis tables 148 obstetrical 145 ratio calculations 149 report, patient 68 resistive index (RI) measurement 44 right ventricular systolic pressure (RVSP) 55 S safety battery 90 biological 92 electrical 88 electromagnetic compatibility 93 equipment 90 save calculations 45 image 6 measurements 41 SAVE key 22 scale 29 scanhead. See transducer screen layout 7 security 15, 16 serial port 19 setup pages 15 shipping specifications 154 shortcut keys 15 Simpsons Rule 53 skin line, definition 158 sleep delay 19 small parts calculations 64 software license 71 SonoHD 158 SonoMB 26, 158 specifications 153 spectral trace 28 standards airborne equipment 155 DICOM 155 electromechanical 154 EMC classification 155 HIPAA 155 steering CPD 28 Doppler 29 storage specifications equipment 154 images 153 stroke volume (SV) 57 superficial, intended uses 12 sweep speed Doppler 29 ECG 39 M Mode 27 symbols, labeling 134 system clean and disinfect 73 controls 5 software 1 status 7, 20 wake up 3 T Technical Support vii temperature limits 154 text 32 text description 7 thermal index (TI) 22, 103, 158 THI 26 time setup 20 tissue Doppler imaging (TDI) 29, 58 tissue models 106 touchpad 6, 8 transcranial, intended uses 13 transducer clean and disinfect 74 curved array 157 definition 158 disinfect 74 exam type 31 general use 10 imaging modes 31 invasive or surgical use 10 linear array 157 preparation 10 problems 71 specifications 153 troubleshoot 71 I n d e x Index 173 U ultrasound terminology 157 unfreeze text 18 USB storage device, export to 38 user account 17 user guide, conventions used vii user setup 16 uses, intended 1113 V variance 28 vascular calculations 67 intended uses 13 velocity measurement 44 velocity time integral (VTI) 54 volume calculation 48 Doppler, adjust 29 volume flow 48 W wall filter 28, 29 warnings, definition vii worksheets, EMED 70 Z zoom 30 174 Index P07662-02

*P07662-02*

 

 

S Series Ultrasound System User Guide S Series Ultrasound System User Guide SonoSite,Inc. 2191930thDriveSE Bothell,WA98021 USA T:18884829449or14259511200 F:14259511201 SonoSiteLtd AlexanderHouse 40AWilburyWay Hitchin HertsSG40AP UK T:+441462444800 F:+441462444801 Caution:

Federal (United States) law restricts this device to sale by or on the order of a physician. S-Cath, S-FAST, S-ICU, S-Nerve, SiteLink, SonoHD, SonoMB, and SonoSite are registered trademarks or trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. Protected by U.S. patents: 5722412, 5817024, 5893363, 6135961, 6364839, 6371918, 6383139, 6416475, 6471651, 6569101, 6648826, 6962566, 7169108. Patents pending P0752501 11/2007 Copyright2007bySonoSite,Inc. Allrightsreserved. ii Contents Introduction Conventions .................................................................................................................. vii Customer comments .................................................................................................. vii Chapter 1: Getting Started About the system .......................................................................................................... 1 Preparing the system ................................................................................................... 1 Compartments and connectors ...................................................................... 1 Installing or removing the battery ................................................................. 3 Using AC power and charging the battery ................................................. 3 Turning the system on or off ............................................................................ 4 Connecting transducers .................................................................................... 5 Inserting and removing USB storage devices ............................................ 6 System controls .............................................................................................................. 7 Screen layout .................................................................................................................. 8 General interaction ....................................................................................................... 9 Touchpad ................................................................................................................ 9 Control keys ............................................................................................................ 9 Entering text .......................................................................................................... 9 Preparing transducers ...............................................................................................10 Intended uses ...............................................................................................................11 Chapter 2: System Setup Displaying the setup pages .....................................................................................13 Restoring default settings ........................................................................................13 Administration setup .................................................................................................14 Security settings .................................................................................................14 User setup .............................................................................................................15 Exporting or importing user accounts .......................................................16 Exporting and clearing the Event log .........................................................16 Logging in as user ..............................................................................................17 Choosing a secure password .........................................................................17 Audio, Battery setup ...................................................................................................18 Connectivity setup ......................................................................................................18 Date and Time setup ..................................................................................................19 Display Information setup ........................................................................................19 Presets setup .................................................................................................................19 System Information setup ........................................................................................20 USB Devices setup .......................................................................................................20 iii Chapter 3: Imaging Imaging modes ............................................................................................................ 21 2D imaging ........................................................................................................... 21 CPD and color Doppler imaging ................................................................... 22 Adjusting depth and gain ........................................................................................ 23 Freezing, viewing frames, and zooming ............................................................. 23 Turning guidelines on and off ................................................................................ 24 Imaging modes and exams available by transducer ...................................... 24 Patient information form .......................................................................................... 27 Images and clips .......................................................................................................... 28 Saving images and clips .................................................................................. 28 Reviewing images and clips ........................................................................... 28 Printing, exporting, and deleting images and clips ............................... 30 Chapter 4: Measurements Working with calipers ................................................................................................ 33 Distance measurements ........................................................................................... 34 Area and circumference measurements ............................................................. 35 Measurement accuracy ............................................................................................. 35 Sources of measurement errors ............................................................................. 36 Chapter 5: Troubleshooting and Maintenance Troubleshooting .......................................................................................................... 37 Software licensing ....................................................................................................... 38 Maintenance ................................................................................................................. 39 Cleaning and disinfecting the ultrasound system ................................. 40 Cleaning and disinfecting transducers ...................................................... 41 Cleaning and disinfecting the battery ....................................................... 43 Chapter 6: Safety Ergonomic safety ......................................................................................................... 51 Position the system ........................................................................................... 52 Position yourself ................................................................................................. 52 Take breaks, exercise, and vary activities ................................................... 53 Electrical safety classification .................................................................................. 53 Electrical safety ............................................................................................................ 53 Equipment safety ........................................................................................................ 56 Battery safety ................................................................................................................ 56 Clinical safety ................................................................................................................ 57 Electromagnetic compatibility ............................................................................... 58 Manufacturers declaration ............................................................................. 59 ALARA principle ........................................................................................................... 62 Applying ALARA ................................................................................................. 63 iv Direct controls .....................................................................................................63 Indirect controls ..................................................................................................64 Receiver controls ................................................................................................64 Acoustic artifacts .........................................................................................................64 Guidelines for reducing MI and TI .........................................................................64 Output display ..............................................................................................................66 Mechanical and thermal indices output display accuracy ..................67 Factors that contribute to display uncertainty ........................................67 Related guidance documents ........................................................................67 Transducer surface temperature rise ...................................................................68 Acoustic output measurement ...............................................................................69 In Situ, derated, and water value intensities .............................................69 Tissue models and equipment survey ........................................................70 Acoustic output tables ..............................................................................................71 Terms used in the acoustic output tables .................................................78 Acoustic measurement precision and uncertainty ................................79 Labeling symbols .........................................................................................................80 Chapter 7: Specifications Supported transducers .............................................................................................85 Imaging modes ............................................................................................................85 Images and clips storage ..........................................................................................85 Accessories .....................................................................................................................85 Peripherals .....................................................................................................................86 Temperature and humidity limits ..........................................................................86 Electrical ..........................................................................................................................87 Battery .............................................................................................................................87 Electromechanical safety standards .....................................................................87 EMC standards classification ...................................................................................87 Airborne equipment standards ..............................................................................88 HIPAA standard ............................................................................................................88 Glossary Terms ................................................................................................................................89 Abbreviations ................................................................................................................91 Index ..............................................................................................................................93 v vi I n t r o d u c t i o n Introduction ThisS SeriesUltrasoundSystemUserGuideprovidesinformationonpreparingandusingthe S Seriesultrasoundsystemandoncleaninganddisinfectingthesystemandtransducers.Italso providessystemspecifications,andsafetyandacousticoutputinformation. Theuserguideisforareaderfamiliarwithultrasoundtechniques.Itdoesnotprovidetraining insonographyorclinicalpractices.Beforeusingthesystem,youmusthaveultrasound training. SeetheapplicableSonoSiteaccessoryuserguideforinformationonusingaccessoriesand peripherals.Seethemanufacturersinstructionsforspecificinformationaboutperipherals. Conventions Theuserguidefollowstheseconventions:

AWARNINGdescribesprecautionsnecessarytopreventinjuryorlossoflife. ACautiondescribesprecautionsnecessarytoprotecttheproducts. Numberedstepsmustbeperformedinaspecificorder. Bulletedlistspresentinformationinlistformatbutdonotimplyasequence. SymbolsandtermsusedonthesystemandtransducerareexplainedinChapter 1,Chapter 6, andGlossary. Customer comments Questionsandcommentsareencouraged.SonoSiteisinterestedinyourfeedbackregardingthe systemandtheuserguide.PleasecallSonoSiteat8884829449intheUS.OutsidetheUS,call thenearestSonoSiterepresentative.YoucanalsoemailSonoSiteat comments@sonosite.com. Introduction vii Fortechnicalsupport,pleasecontactSonoSiteasfollows:

SonoSite Technical Support Phone (US or Canada):

877-657-8118 Phone (Outside US and Canada):

425-951-1330 Or call your local representative. Fax:

E-mail:

Web site:

425-951-6700 service@sonosite.com www.sonosite.com. Click Support & Service. Europe Service Center:

+44-(0)1462-444-800 e-mail: uk.service@sonosite.com viii Chapter 1: Getting Started About the system TheSonoSiteS Seriesultrasoundsystemisaportable,softwarecontrolleddeviceusing alldigitalarchitecture.TheSSeriesincludestheSCathultrasoundsystem,SFAST ultrasoundsystem,SICUultrasoundsystem,andtheSNerveultrasoundsystem. Thesystemhasmultipleconfigurationsandfeaturesetsusedtoacquireanddisplay highresolution,realtimeultrasoundimages.Featuresavailableonyoursystemdependon systemconfiguration,transducer,andexamtype. Alicensekeyisrequiredtoactivatethesoftware.SeeSoftwarelicensingonpage 38.On occasion,asoftwareupgrademayberequired.SonoSiteprovidesaUSBdevicecontainingthe software.OneUSBdevicecanupgrademultiplesystems. G e t t i n g S t a r t e d To use the ultrasound system 1 Turnthesystemon.(Forpowerswitchlocation,seeSystemcontrolsonpage 7.) 2 Attachatransducer. 3 PressPatient,andcompletethepatientinformationform. 4 Pressanimagingmodecontrolkey:2DorColor. Preparing the system Compartments and connectors Thebackofthesystemhascompartmentsforthebatteryandtransduceraswellasconnectors forUSBdevices,powercords,cables,andmore.Thesidehasadditionalconnectors. Chapter 1: Getting Started 1 1 2 3 3 4 Figure 1.1 System Back (Left) and Side (Right):

1 2 3 4 Handle Transducer Connectors

(See the table Connectivity Symbols on Back and Side of System) Battery compartment 2 Each connector on the back and side of the system has a symbol that describes its use. Connectivity Symbols on Back and Side of System Symbol Definition Symbol Definition DC input Print control USB Ethernet*

RS-232 (DVD recorder or bar code scanner)

* Not currently supported Installing or removing the battery S-video out S-video in DVI video out Composite video out Audio out G e t t i n g S t a r t e d WARNING:

To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing. To avoid data loss and to conduct a safe system shutdown, always keep a battery in the system. To install the battery 1 Disconnectthepowersupplyfromtheultrasoundsystem. 2 Slidethetwoprongsatthebottomofthebatteryintothebatterycompartmentontheback ofthesystem. 3 Lowerthebatteryintothecompartment. 4 Pushdownonthelockingleveratthetopofthebatterytosecurethebattery. To remove the battery 1 Disconnectthepowersupplyfromtheultrasoundsystem. 2 Pushdownonthelockingleveratthetopofthebattery,andliftthebatteryup. Using AC power and charging the battery ThebatterychargeswhenthesystemisconnectedtotheACpowersupply.Afullydischarged batteryrechargesinlessthanfivehours. ThesystemcanrunonACpowerandchargethebatteryifACpowerisconnectedtothe system. Chapter 1: Getting Started 3 Thesystemcanrunonbatterypowerforuptotwohours,dependingontheimagingmodeand thedisplaybrightness. WARNING:

The equipment shall be connected to a center-tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system. Caution:

Verify that the hospital supply voltage corresponds to the power supply voltage range. See Electrical on page 87. To operate the system using AC power 1 ConnecttheDCpowercablefromthepowersupplytotheconnectoronthesystem.See Figure 1.1onpage 2. 2 ConnecttheACpowercordtothepowersupplyandtoahospitalgradeelectricaloutlet. Turning the system on or off Caution:

Do not use the system if an error message appears on the display. Note the error code and turn off the system. Call SonoSite or your local representative. To turn the system on or off

Pressthepowerswitch.(SeeSystemcontrolsonpage 7.) To wake up the system Toconservebatterylifewhilethesystemison,thesystemgoesintosleepmodeifuntouched forapresettime.Toadjustthetimeforsleepdelay,seeAudio,Batterysetuponpage 18.

Pressakey,ortouchthetouchpad. 4 Connecting transducers WARNING:

To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in the S Stand or on a convenient surface to allow air flow past the connector. Caution:

To avoid damaging the transducer connector, do not allow foreign material in the connector. G e t t i n g S t a r t e d Figure 1.2 Connect the Transducer To connect a transducer 1 Pullthetransducerlatchup,androtateitclockwise. 2 Alignthetransducerconnectorwiththeconnectoronthebackofthesystem. 3 Insertthetransducerconnectorintothesystemconnector. 4 Turnthelatchcounterclockwise. 5 Pressthelatchdown,securingthetransducerconnectortothesystem. To remove a transducer 1 Pullthetransducerlatchup,androtateitclockwise. 2 Pullthetransducerconnectorawayfromthesystem. Chapter 1: Getting Started 5 Inserting and removing USB storage devices Imagesandclipsaresavedtointernalstorageandareorganizedinasortablepatientlist.You canarchivetheimagesandclipsfromtheultrasoundsystemtoaPCusingaUSBstorage device.AlthoughtheimagesandclipscannotbeviewedfromaUSBstoragedeviceonthe ultrasoundsystem,youcanremovethedeviceandviewthemonyourPC. YoucanalsoimportandexportuseraccountsandtheeventlogusingaUSBstoragedevice. TherearethreeUSBportsonthesystem:twoontheback,andoneontheside.Foradditional USBports,youcanconnectaUSBhubintoanyUSBport. WARNING:

To avoid damaging the USB storage device and losing patient data from it, observe the following:

Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break. Caution:

If the USB icon does not appear in the system status area on-screen, the USB storage device may be defective or password-protected. Turn the system off and replace the device. To insert a USB storage device

InserttheUSBstoragedeviceintoaUSBportonthesystem.SeeFigure 1.1onpage 2. TheUSBstoragedeviceisreadywhentheUSBiconappears. Toviewinformationaboutthedevice,seeUSBDevicessetuponpage 20. To remove a USB storage device RemovingtheUSBstoragedevicewhilethesystemisexportingmaycausetheexportedfiles tobecorruptedorincomplete. 1 WaitfivesecondsaftertheUSBanimationstops. 2 RemovetheUSBstoragedevicefromtheport. 6 System controls 1 2 3 G e t t i n g S t a r t e d 2 Figure 1.3 System Controls:

4 5 1 2 3 4 5 Power switch Control keys Control knobs Turns the system on and off. Perform an action or make a selection based on context. Current names appear on-screen adjacent to the keys. Adjust gain, depth, cine buffer, ROI box, and brightness. Sometimes perform an action. Are turned or pressed. Touchpad Moves the pointer and other items. Touchpad key Works in conjunction with the touchpad. Is pressed to activate an item on-screen. Chapter 1: Getting Started 7 Screen layout 1 2 3 4 5 6 7 8 9 Figure 1.4 Screen Layout Mode Data Area Current imaging mode information (for example, Gen, S, THI). S and THI are on when available on the transducer and are not user-controlled. For definitions, see Glossary. Orientation Marker Provides indication for image orientation. Image Ultrasound image. Measurement Data Area Patient Header System Status Depth Marker Exam label Control keys Current data on measurements. Includes current patient name, patient ID number, institution, user, and date/time. Information on system status (for example, exam type, transducer, AC connected, battery charging, and USB). Marks in .5 cm, 1 cm, and 5 cm increments depending on depth. To specify style, see Presets setup on page 19. Preset exam label from patient information form. Controls available in the current context. (See also Control keys on page 9.) 1 2 3 4 5 6 7 8 9 8 General interaction Touchpad Informsandthesetuppages,thetouchpadissimilartoamouseonportablePCs.Usingthe touchpad,youmovethepointertoanitemandthenclick(pressthekeybelowthetouchpad) toactivatethatitem. Inothercontexts,thetouchpadadjustsandmovesitemsonscreen:calipers,regionofinterest

(ROI)box,andmore. Control keys Thecontrolkeysdisplayforms,adjustsettings,andperformactionssuchasfreezingand zooming.Thefunctionalitydependsoncontext.Thecurrentnameappearsonscreennexttothe key.Controlkeysareusuallypressed,butinformsyoucanalsoclickthem.ThePage x/x controlkeydisplaysadditionalcontrolkeys. Acontrolkeyfunctionsinoneofthefollowingways:

Cycle Movesthroughalistofsettings. On-Off Turnsafeatureonoroff. Action Performsanactionsuchassavingaclip. G e t t i n g S t a r t e d Figure 1.5 Control key names, lower screen (Color imaging shown) Entering text Informs,youcanentertextintextfieldsusingeithertheonscreenkeyboardoranexternalUSB keyboardconnectedtoaUSBportonthesystem. To enter text in text fields 1 Clickatextfield. Theonscreenkeyboardappearswiththetextfieldatthetop. 2 Clickeachcharacteryouwanttoenter.Ifanexternalkeyboardisconnected,youcanenter charactersbytyping. Thekeydisplaysandhidesinternationalcharacters. TheSYMBOLSkeydisplayssymbolsandpunctuation. TheCAPSLOCKkey turnscapitallettersonandoff. TheSHIFTkey turnscapitallettersonoroffforthenextletterentered. Chapter 1: Getting Started 9 TheDELETEkeydeletesthecharacterrightofthepointer. 3 (Optional)Navigateamongtextfields:

ClickNexttoadvancetothenextfield. ClickPrevtoreturntothepreviousfield. 4 Toexitthekeyboard,clickoneofthefollowing:

OKtosavechanges. 2Dtosavechangesanddisplay2Dimaging. Preparing transducers WARNING:

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. Some gels and sterilants can cause an allergic reaction on some individuals. Caution:

To avoid damage to the transducer, use only gels recommended by SonoSite. Using gels other than the one recommended by SonoSite can damage the transducer and void the warranty. If you have questions about gel compatibility, contact SonoSite or your local representative. SonoSite recommends that you clean transducers after each use. See Cleaning and disinfecting transducers on page 41. Acousticcouplinggelmustbeusedduringexams.Althoughmostgelsprovidesuitable acousticcoupling,somegelsareincompatiblewithsometransducermaterials.SonoSite recommendsAquasonicgelandprovidesasamplewiththesystem. Forgeneraluse,applyaliberalamountofgelbetweenthetransducerandthebody.For invasiveorsurgicaluse,installatransducersheath. WARNING:

To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure. 10 To install a transducer sheath SonoSiterecommendstheuseofmarketcleared,transducersheathsforintracavitaryor surgicalapplications.Tolessentheriskofcontamination,installthesheathonlywhenyouare readytoperformtheprocedure. 1 Placegelinsidethesheath. 2 Insertthetransducerintothesheath. 3 Pullthesheathoverthetransducerandcableuntilthesheathisfullyextended. 4 Securethesheathusingthebandssuppliedwiththesheath. 5 Checkforandeliminatebubblesbetweenthefaceofthetransducerandthesheath. Bubblesbetweenthefaceofthetransducerandthesheathmayaffecttheultrasoundimage. 6 Inspectthesheathtoensurethattherearenoholesortears. G e t t i n g S t a r t e d Intended uses Theintendedusesforeachexamtypeareasfollows.Fortheintendedtransducerforeachexam type,seeImagingmodesandexamsavailablebytransduceronpage 24. Abdominal Imaging Applications Thissystemtransmitsultrasoundenergyintotheabdomen ofpatientsusing2D,SonoMBtechnology,colorDoppler(Color),colorpowerDoppler

(CPD),andTissueHarmonicImaging(THI)toobtainultrasoundimages.Theliver,kidneys, pancreas,spleen,gallbladder,bileducts,transplantedorgans,abdominalvessels,and surroundinganatomicalstructurescanbeassessedforthepresenceorabsenceofpathology transabdominally. Cardiac Imaging Applications Thissystemtransmitsultrasoundenergyintothethoraxof patientsusing2D,SonoMBtechnology,colorDoppler(Color),andTissueHarmonicImaging

(THI),toobtainultrasoundimages.Theheart,cardiacvalves,greatvessels,surrounding anatomicalstructures,overallcardiacperformance,andheartsizecanbeassessedforthe presenceorabsenceofpathology. Gynecology and Infertility Imaging Applications Thissystemtransmitsultrasoundenergyin thepelvisandlowerabdomenusing2D,SonoMBtechnology,colorpowerDoppler(CPD),and colorDoppler(Color)toobtainultrasoundimages.Theuterus,ovaries,adnexa,and surroundinganatomicalstructurescanbeassessedforthepresenceorabsenceofpathology transabdominallyortransvaginally. Interventional Imaging Applications Thissystemtransmitsultrasoundenergyintothevarious partsofthebodyusing2D,SonoMBtechnology,colorDoppler(Color),colorpowerDoppler

(CPD),andTissueHarmonicImaging(THI)toobtainultrasoundimagesthatprovideguidance duringinterventionalprocedures.Thissystemcanbeusedtoprovideultrasoundguidancefor biopsyanddrainageprocedures,vascularlineplacement,peripheralnerveblocks,spinalnerve blocksandtaps,amniocentesisandotherobstetricalprocedures,andprovideassistanceduring abdominal,breast,andneurologicalsurgery. Chapter 1: Getting Started 11 Obstetrical Imaging Applications Thissystemtransmitsultrasoundenergyintothepelvisof pregnantwomenusing2D,SonoMBtechnology,colorDoppler(Color),andcolorpower Doppler(CPD)toobtainultrasoundimages.Thefetalanatomy,amnioticfluid,and surroundinganatomicalstructurescanbeassessedforthepresenceorabsenceofpathology transvaginally.CPDandcolorDoppler(Color)imagingisintendedforhighriskpregnant women. WARNING:

To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses. CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation

(IUGR). Pediatric Imaging Applications Thissystemtransmitsultrasoundenergyintothepediatric patientsusing2D,SonoMBmultibeamtechnology,colorDoppler(Color),andcolorpower Doppler(CPD)toobtainultrasoundimages.Thepediatricabdominalandpelvicanatomy, pediatrichips,andsurroundinganatomicalstructurescanbeassessedforthepresenceor absenceofpathology. Superficial Imaging Applications Thissystemtransmitsultrasoundenergyintovariousparts ofthebodyusing2D,SonoMBmultibeamtechnology,colorDoppler(Color),andcolorpower Doppler(CPD)toobtainultrasoundimages.Thebreast,thyroid,testicle,lymphnodes,hernias, musculoskeletalstructures,softtissuestructures,andsurroundinganatomicalstructurescan beassessedforthepresenceorabsenceofpathology.Thissystemcanbeusedtoprovide ultrasoundguidanceforbiopsyanddrainageprocedures,vascularlineplacement,peripheral nerveblocks,andspinalnerveblocksandtaps. Vascular Imaging Applications Thissystemtransmitsultrasoundenergyintothevariousparts ofthebodyusing2D,SonoMB,colorDoppler(Color),andcolorpowerDoppler(CPD)to obtainultrasoundimages.Thecarotidarteries,deepveins,andarteriesinthearmsandlegs, superficialveinsinthearmsandlegs,greatvesselsintheabdomen,andvarioussmallvessels feedingorganscanbeassessedforthepresenceorabsenceofpathology. 12 Chapter 2: System Setup Thesetuppagesletyoucustomizethesystemandsetpreferences. Displaying the setup pages To display a setup page 1 In2Dimagingmode,dooneofthefollowing:

PressPatient,andthenpressSetuponthehorizontalrowofcontrolkeys. PressSetupontheverticalrowofcontrolkeys. 2 ClickthesetuppageunderSetup Pages. Toreturntoimagingfromasetuppage,pressDone. Restoring default settings To restore default settings for a setup page

Onthesetuppage,press Reset. To restore all default settings 1 Turnthesystemoff. 2 ConnectthesystemtoACpower.(SeeTooperatethesystemusingACpoweron page 4.) 3 Simultaneouslypressthepowerkeyandthecontrolkeybelowit(theupperleftcontrol key). Thesystembeepsseveraltimes. S y s t e m S e t u p Chapter 2: System Setup 13 Administration setup OntheAdministrationsetuppage,youcanconfigurethesystemtorequireuserstologin andenterpasswords.Requiredloginhelpsprotectpatientdata.Youcanalsoaddand deleteusers,changepasswords,importandexportuseraccounts,andviewtheeventlog. Security settings WARNING:

Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the European Union Data Protection Directive (95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information. Securitysettingsonthesystemallowyoutomeettheapplicablesecurityrequirements listedintheHIPAAstandard.Usersareultimatelyresponsibleforensuringthesecurity andprotectionofallelectronicprotectedhealthinformationcollected,stored,reviewed, andtransmittedonthesystem. To log in as Administrator 1 OntheAdministrationsetuppage,typeAdministratorintheNamebox.(SeeEntering textonpage 9.) 2 TypetheadministratorpasswordinthePasswordbox. Ifyoudonthavetheadministratorpassword,contactSonoSite.(SeeSonoSiteTechnical Supportonpage viii.) 3 ClickLogin. To log out as Administrator

Turnofforrestartthesystem. To require user login YoucansetthesystemtodisplaytheUserLoginscreenatstartup. 1 LoginasAdministrator. 2 IntheUser Loginlist,clickOn. Onrequiresausernameandpasswordatstartup. Offallowsaccesstothesystemwithoutausernameandpassword. 14 To change the administrator password or let users change passwords 1 LoginasAdministrator. 2 UnderUser List,clickAdministrator. 3 Doanyofthefollowing:

Changetheadministratorpassword:UnderUser Information,typethenew passwordinthePasswordboxandConfirmbox.(SeeChoosingasecurepassword onpage 17.) Letuserschangetheirpasswords:SelectthePassword changescheckbox. 4 ClickSave. User setup To add a new user 1 LoginasAdministrator. 2 ClickNew. 3 UnderUser Information,fillintheName,Password,andConfirmboxes.(SeeChoosing asecurepasswordonpage 17.) 4 (Optional)IntheUser box,typetheusersinitialstodisplaytheminthepatientheader andtheUserboxinthepatientinformationform. 5 (Optional)SelecttheAdministration Accesscheckboxtoallowaccesstoall administrationprivileges. S y s t e m S e t u p 6 ClickSave. To modify user information 1 LoginasAdministrator. 2 UnderUser List,clicktheuser. 3 UnderUser Information,makechangesasdesired. 4 ClickSave. Anychangetotheusernamereplacesthepreviousname. To delete a user 1 LoginasAdministrator. 2 UnderUser List,clicktheuser. 3 ClickDelete. 4 Click Yes. Chapter 2: System Setup 15 To change a user password 1 LoginasAdministrator. 2 IntheUser List,clicktheuser. 3 TypethenewpasswordinthePasswordboxandConfirmbox. 4 ClickSave. Exporting or importing user accounts Theexportandimportcommandsletyouconfiguremultiplesystemsandbackupuser accountinformation. To export user accounts 1 InsertaUSBstoragedevice. 2 LoginasAdministrator. 3 PressExport.AlistofUSBdevicesappears. 4 ClicktheUSBstoragedevice,andclickExport. AllusernamesandpasswordsarecopiedtotheUSBstoragedevice. To import user accounts 1 InserttheUSBstoragedevicethatcontainstheaccounts. 2 LoginasAdministrator. 3 PressImport. 4 ClicktheUSBstoragedevice,andclickImport. 5 ClickDoneinthedialogboxthatappears. Thesystemrestarts.Allusernamesandpasswordsonthesystemarereplacedwiththe importeddata. Exporting and clearing the Event log TheEventlogcollectserrorsandeventsandcanbeexportedtoaUSBstoragedeviceand readonaPC. To view the Event log 1 LoginasAdministrator. 2 PressLog. TheEventlogappears. Toreturntothepreviousscreen,pressBack. 16 To export the Event log TheEventloghasthefilename(log.txt).ExportingtheEventlogtoaUSBstoragedevice overwritesanyexistinglog.txtfile. 1 InsertaUSBstoragedevice. 2 PressLogandthenpressExport. AlistofUSBdevicesappears. 3 ClicktheUSBstoragedevice,andclickExport. TheEventlogisatextfilethatyoucanopeninatexteditingapplication(forexample, MicrosoftWordorNotepad). To clear the Event log 1 ViewtheEventlog. 2 PressClear. 3 ClickYes. Logging in as user Ifuserloginisrequired,theUserLoginscreenappearswhenyouturnonthesystem.(See Torequireuserloginonpage 14.) To log in as user 1 Turnonthesystem. 2 IntheUser Loginscreen,typeyournameandpassword,andclickOK. To log in as guest Guestscanscanbutcantaccesssystemsetupandpatientinformation. 1 Turnonthesystem. 2 IntheUser Loginscreen,clickGuest. To change your password 1 Turnonthesystem. 2 IntheUser Loginscreen,clickPassword. 3 Typeyouroldandnewpasswords,confirmthenewpassword,andthenclickOK. Choosing a secure password Toensuresecurity,chooseapasswordthatcontainsuppercasecharacters(AZ),lowercase characters(az),andnumbers(09).Passwordsarecasesensitive. S y s t e m S e t u p Chapter 2: System Setup 17 Audio, Battery setup OntheAudio,Batterysetuppage,youcanselectoptionsfromthefollowinglists:

Key click:ClickOnorOffforkeystomakeaclickingsoundwhenpressed. Beep alert: ClickOnorOffforthesystemtobeepwhensaving,warning,starting,or shuttingdown. Sleep delay:ClickOff,or5or10minutestospecifytheperiodofinactivitybeforethe systemgoesintosleepmode. Power delay:ClickOff,or15or30minutestospecifytheperiodofinactivitybeforethe systemautomaticallyturnsoff. Connectivity setup OntheConnectivitysetuppage,youselectoptionsforusingdevicesandforalertswhen internalstorageisfull. To configure the system for a printer 1 Setuptheprinterhardware.(SeeinstructionsincludedwiththeprinterorSSeries stand.) 2 OntheConnectivitysetuppage,clicktheprinterinthePrinterlist. To configure the system for a DVD recorder or bar code scanner 1 OntheConnectivitysetuppage,dothefollowing:

(DVDrecorder)IntheVideo Modelist,clickthevideostandard:NTSCorPAL. IntheSerial Portlist,clicktheperipheral. 2 ClickYestorestartthesystem. 3 Attachaserialcable(RS232)fromtheserialportonthebackofthesystemtothe peripheral. To receive storage alerts

OntheConnectivitysetuppage,selectInternal Storage Capacity Alert. Thesystemdisplaysamessageifinternalstorageisnearcapacitywhenyouendan exam. 18 Date and Time setup To set the date and time

OntheDateandTimesetuppage,dothefollowing:

IntheDate box,typethecurrentdate.(SeeEnteringtextonpage 9.) IntheTime box,typethecurrenttimein24 hourformat(hoursandminutes). Display Information setup OntheDisplayInformationsetuppage,youcanspecifywhichdetailsappearonscreen duringimaging.Youcanselectcheckboxesinthefollowingsections:

Patient Header: Informationfromthepatientinformationform.(SeePatient informationformonpage 27.) Mode Data:Imaginginformation. System Status:Power,battery,printer,andsimilarinformation. Presets setup ThePresetssetuppagehassettingsforgeneralpreferences.Youcanselectfromthe followinglists:

Depth Markers:Type 1displaysunnumberedmarkers,withthemaximumdepth numberinthelowerrightscreen.Type 2displaysmarkerswithnumbers. Thermal Index:YoucanselectTIS,TIB,orTIC.Thedefaultsettingisbasedonexamtype:

OBisTIB,TCDisTIC,andallothersareTIS. Clip Length: Cliplengthinseconds. Language:Thesystemlanguage.Changingthelanguagerequiresrestartingthesystem. Display Brightness:Highdisplaysbrighterkeynamesandiconsandissuitablefora brightenvironment,suchasdaylight.Lowdisplaysdimmerkeynamesandiconsandis suitableforadarkenvironment. Auto save Pat. Form:Automaticallysavesthepatientinformationformasanimagein thepatientsfile. S y s t e m S e t u p Chapter 2: System Setup 19 System Information setup TheSystemInformationsetuppagedisplayssystemhardwareandsoftwareversions,and licenseinformation. SeealsoToenteralicensekeyonpage 38. USB Devices setup OntheUSBDevicessetuppage,youcanviewinformationaboutconnectedUSBdevices, includingspaceavailability.Youcanalsospecifyafileformatforimagesyouexporttoa USBstoragedevice. To specify a file format for exported images Theimageformatyouspecifyaffectsonlystillimages.ClipsexportinH.264videosaved asMP4files.Toviewthem,SonoSiterecommendsQuickTime7.0orlater. 1 OntheUSBDevicessetuppage,clickExport. 2 UnderSiteLink,selectanimageformat.ForJPEGimageformat,alsoselectaJPEG compression. Ahighcompressionhasasmallerfilesizebutlessdetail. 3 ClickasortorderunderSort By. Thesortorderspecifieshowexportedfilesareorganized. Toreturntothepreviousscreen,clickDevices. 20 Chapter 3: Imaging Imaging modes ThesystemhasahighperformanceLCDandadvancedimageoptimizationtechnologythat greatlysimplifiesusercontrols.Imagingmodesavailabledependonthetransducerandexam type.SeeImagingmodesandexamsavailablebytransduceronpage 24. 2D imaging 2Disthesystemsdefaultimagingmode.Thesystemdisplaysechoesintwodimensionsby assigningabrightnesslevelbasedontheechosignalamplitude.Toachievethebestpossible imagequality,properlyadjustthedisplaybrightness,gain,depthsettings,viewingangle,and examtype.Also,useanoptimizationsettingthatbestmatchesyourneeds. To display the 2D image 1 Doanyofthefollowing:

Turnonthesystem. Press2D. 2 Adjustsettings.See2Dsettings. 2D settings In2Dimaging,thefollowingcontrolkeysadjustsettings.SeealsoAdjustingdepthandgain onpage 23. 2D settings I m a g n g i Control key Icon Description Auto Gain Brightness The gain adjusts each time you press the key. To adjust gain manually, see Adjusting depth and gain on page 23. Adjusts the display brightness. Press Bright and then turn the left-hand knob. Settings range from 1 to 10. (You can also adjust the brightness of only the key names and icons. See Presets setup on page 19.) The display brightness affects battery life. To conserve battery life, adjust brightness to a lower setting. Chapter 3: Imaging 21 2D settings (Continued) Control key Icon Description Optimize Orientation SonoMB (MB) Page x/x Settings are as follows:

Res provides the best possible resolution. Gen provides a balance between resolution and penetration. Pen provides the best possible penetration. Some of the parameters optimized to provide the best image include focal zones, aperture size, frequency (center and bandwidth), and waveform. They cannot be adjusted by the user. Select from four image orientations: U/R (Up/Right), U/L (Up/Left), D/L (Down/Left), D/R (Down/Right). MB On and MB Off turn SonoMB technology on and off. When SonoMB is on, MB appears in the upper left-hand screen. SonoMB depends on transducer and exam type. Indicates which page of options is displayed. Press to display the next page. CPD and color Doppler imaging ColorpowerDoppler(CPD)andcolorDoppler(Color)areoptionalfeatures. CPDisusedtovisualizethepresenceofdetectablebloodflow.Colorisusedtovisualizethe presence,velocity,anddirectionofbloodflowinawiderangeofflowstates. To display the CPD or Color image 1 PressColor. AROIboxappearsinthecenterofthe2Dimage. 2 PressCPDorColorontheleft. InColorimaging,theColorindicatorbarontheupperlefthandscreendisplaysvelocityin cm/s. 3 Usingthetouchpad,positiontheROIboxasneeded. Agreenoutlineshowsthechange. 22 Adjusting depth and gain To adjust depth Youcanadjustthedepthinallimagingmodes.Theverticaldepthscaleismarkedin0.5 cm, 1 cm,and5 cmincrements,dependingonthedepth.Tochangethestyleofdepthmarkers,see Presetssetuponpage 19.

TurntheDepthknob:

Rightincreasesthedisplayeddepth. Leftdecreasesthedisplayeddepth. To adjust gain manually Toadjustgainautomaticallyin2D,see2Dsettingsonpage 21. 1 Pressthelefthandknobtoselectasetting:

Near adjuststhegainappliedtothenearfieldoftheimage. Far adjuststhegainappliedtothefarfieldoftheimage. adjuststheoverallgainappliedtotheentireimage. Gain InCPDorColorimaging,theOverallsettingaffectsthecolorgainappliedtotheregionof interest(ROI)box.TheNearandFarsettingsaffectonlythe2Dimage.(Nearandfar correspondtothetimegaincompensation[TGC]controlsonotherultrasoundsystems.) 2 Turntheknob. I m a g n g i Freezing, viewing frames, and zooming To freeze or unfreeze an image

PressFreeze. Onafrozenimage,thecineiconandframenumberappearinthesystemstatusarea. To move forward or backward in the cine buffer

Onafrozenimage,turnthecineknob

. Thetotalnumberofframesappearsnexttothecineicon.Thenumberchangestothecurrent framenumberasyoumoveforwardorbackward. Chapter 3: Imaging 23 To zoom in on an image Youcanfreezeorunfreezetheimageorchangetheimagingmodeatanytimewhilezooming. 1 PressZoom.AROIboxappears. 2 Usingthetouchpad,positiontheROIboxasdesired. 3 PressZoomagain. TheimageintheROIboxismagnifiedby100%. 4 (Optional)Iftheimageisfrozen,usethetouchpadtopantheimageup,down,left,andright. Toexitzoom,pressZoomagain. Turning guidelines on and off Guidelinesareforneedleguidanceandareanoptionalfeature. To turn guidelines on or off

Ona2Dimage,pressoneofthefollowingcontrolkeys:

Biopsy

: Thisfeaturedependsontransducertype.Formoreinformation,seeSonoSite BiopsyUserGuide. Guide: Thisfeaturedependsontransducerandexamtype.Formoreinformation,see SonoSiteBracketandNeedleGuideUserGuide. Imaging modes and exams available by transducer WARNING:

To prevent misdiagnosis or harm to the patient, understand your systems capabilities prior to use. The diagnostic capability differs for each transducer, exam type, and imaging mode. In addition, transducers have been developed to specific criteria depending on their physical application. These criteria include biocompatability requirements. Thetransduceryouusedetermineswhichexamtypesareavailable.Inaddition,theexamtype youselectdetermineswhichimagingmodesareavailable. To change the exam type

Dooneofthefollowing:

In2Dimaging,pressExam,andthenclicktheexamtypeinthemenu. Onthepatientinformationform,clicktheexamtypeintheExamlist.(SeePatient informationformonpage 27.) 24 Imaging modes and exams available by transducer Transducer C11x C60x Exam Type1 Nrv Vas Abd HFL38x ICTx Nrv Bre Nrv SmP Vas Ven Gyn OB S Series System S-Nerve S-Nerve S-Cath S-FAST S-ICU S-Nerve S-Cath S-Nerve S-Cath S-FAST S-ICU S-Cath S-FAST S-ICU S-Nerve S-Cath S-FAST S-ICU S-FAST S-FAST Imaging Mode 2D2 CPD Color X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X I m a g n g i Chapter 3: Imaging 25 Imaging modes and exams available by transducer (Continued) Transducer L25x L38x Exam Type1 Nrv Sup Vas Ven Bre Nrv SmP Vas Ven P21x Abd Crd S Series System S-Nerve S-Cath S-Cath S-ICU S-Nerve S-Cath S-ICU S-Cath S-Nerve S-Cath S-FAST S-ICU S-Cath S-FAST S-ICU S-Nerve S-Cath S-FAST S-ICU S-Cath S-FAST S-ICU S-FAST S-ICU Imaging Mode 2D2 CPD Color X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast, Crd = Cardiac, Nrv = Nerve, OB = Obstetrical, SmP = Small Parts, Sup =

Superficial, Vas = Vascular, Ven = Venous. 2. The optimization settings for 2D are Res, Gen, and Pen. 26 Patient information form Thepatientinformationformletsyouenterpatientidentification,exam,andclinical informationforthepatientexam. Whenyoucreateanewpatientinformationform,allimagesandotherdatayousaveduring theexamarelinkedtothatpatient.(SeeSavingimagesandclipsonpage 28.) To create a new patient information form 1 In2D,pressPatient. New. 2 Press 3 Fillintheformfields.SeePatientinformationformfieldsonpage 28andEnteringtext onpage 9. 4 PressDone. To edit a patient information form Youcaneditpatientinformationduringtheexam.However,ifyouchangethepatientnameor IDaftersavinganimage,anewpatientinformationformiscreated. 1 In2D,pressPatient. 2 IfyouneedtochangethepatientnameorID,saveanydatayouwanttokeep. 3 Makechangesasdesired. 4 Pressoneofthefollowing:

Canceltoundochangesandreturntoimaging. Donetosavechangesandreturntoimaging. To end the exam 1 Makesurethatyouhavesavedimagesandotherdatayouwanttokeep.(SeeImagesand clipsonpage 28.) I m a g n g i 2 In2D,pressPatient. 3 Dooneofthefollowing:

PressEnd Exam. Press Newtobeginanewpatientinformationform.(SeeTocreateanewpatient informationformonpage 27.) Chapter 3: Imaging 27 Patient information form fields Field Last First ID Exam Description Patient name Patient identification number Exam type Exam label Exam-specific label that appears in the lower-right screen User User initials, up to 3 characters. Appears in the patient list and image header. Institution Institution name. Appears in the image header. Images and clips Saving images and clips Whenyousaveanimageorclip,itsavestointernalstorage.ThesystembeepsafterwardifBeep Alertison,andthepercentageiconflashes.(SeeAudio,Batterysetuponpage 18.) Thepercentageiconshowsthepercentageofspaceusedininternalstorage.Toreceivealerts whenstorageisnearcapacity,seeToreceivestoragealertsonpage 18. Toaccesssavedimagesandclips,openthepatientlist.SeeReviewingimagesandclips. To save an image

PressSave. To save a clip

PressClip. Tospecifycliplength,seePresetssetuponpage 19. Reviewing images and clips Caution:

If the internal storage icon does not appear in the system status area, internal storage may be defective. Contact SonoSite Technical Support. (See SonoSite Technical Support on page viii.) Thepatientlistletsyouorganizesavedimagesandclipsfromacentrallocation. 28 Figure 3.1 Patient List To open the patient list 1 In2D,pressPatient. 2 PressReview 3 Ifthereisacurrentpatient,pressList. I m a g n g i To sort the patient list Afterthesystemstarts,thepatientlistisarrangedbydateandtime,withthemostrecent patientfilefirst.Youcanresortthepatientlistasneeded.

Clickthecolumnheadingthatyouwanttosortby.Clickitagainifsorting inreverseorder. Note: Theselectioncolumn issortable. To select patients in the patient list

Selectthecheckboxforoneormorepatients. Clicking Select Allselectsallpatients. Todeselectpatients,clearcheckedboxesorclickClear All. Chapter 3: Imaging 29 To review images and clips Youcanreviewonlyonepatientsimagesandclipsatatime. 1 Inthepatientlist,clickthepatientwhoseimagesandclipsyouwanttoreview. Thepatientrowishighlighted. 2 PresstheReviewknob. Theiconontheknobchangestotwonumbers:thefiledisplayedandthetotalfilessaved. 3 Turntheknobtocycletotheimageorclipyouwanttoreview 4 (ClipOnly)PressthePlaykey. Theclipplaysautomaticallyafterloading.Theloadtimedependsoncliplength. YoucanpressthePausekeytofreezetheclipandcanturntherighthandknob playbackspeed. fora 5 Turnthelefthandknob Toreturntothepatientlist,pressList.Toreturntoimaging,pressDone. x/xtocycletothenextimageorclipyouwanttoview. Printing, exporting, and deleting images and clips WARNING:

To avoid damaging the USB storage device and losing patient data from it, observe the following:

Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break. To print an image 1 Verifythataprinterisselected.SeeToconfigurethesystemforaprinteronpage 18. 2 Dooneofthefollowing:

Inthepatientlist,reviewthepatientsimages.PressPrintwhentheimageappears. Freezetheimage,andpressPrint. To print multiple images 1 Verifythataprinterisselected.SeeToconfigurethesystemforaprinteronpage 18. 2 Dooneofthefollowing:

Printallimagesformultiplepatients:Selectoneormorepatientsinthepatientlist.Then press Print. Printallimagesforonepatient:Highlightthepatientinthepatientlist,andpressPrint. Eachimageappearsbrieflyonscreenwhileprinting. 30 To export images and clips to a USB storage device AUSBstoragedeviceisfortemporarystorageofimagesandclips.Patientexamsshouldbe archivedregularly.Tospecifyfileformat,seeUSBDevicessetuponpage 20.Apatientexam mustbeendedbeforeyoucanexportitsimagesandclips.SeeToendtheexam. 1 InserttheUSBstoragedevice.(SeeInsertingandremovingUSBstoragedeviceson page 6.) 2 Inthepatientlist,selectthepatientswhoseimagesandclipsyouwanttoexport. 3 SelectExp. USB onscreen.AlistofUSBdevicesappears. 4 SelecttheUSBstoragedevice,andselectExport. OnlyavailableUSBdevices(forexample,notpasswordprotected)areselectable. ThefilesarefinishedexportingapproximatelyfivesecondsaftertheUSBanimationstops. RemovingtheUSBstoragedeviceorturningoffthesystemwhileexportingmaycause exportedfilestobecorruptedorincomplete.Tostopinprogressexporting,select Cancel Export. To delete images and clips 1 Selectoneormorepatientsinthepatientlist. 2 SelectDeletetodeletetheselectedpatients.Aconfirmationscreenappears. I m a g n g i Chapter 3: Imaging 31 32 Chapter 4: Measurements Youcanperformdistance,area,andcircumferencemeasurementsinanyimagingmode. Measurementsareperformedonfrozenimages. Youcanperformmultiplemeasurementsatonetime:uptoeightdistancemeasurementsor fourarea/circumferencemeasurementsoracombination;forexample,sixdistance measurementsandonearea/circumferencemeasurement. Figure 4.1 2D image with one distance and one circumference measurement Working with calipers Whenmeasuring,youworkwithcalipers.Resultsbasedonthecaliperspositionappearatthe bottomofthescreen.Theresultsupdateasyourepositionthecalipersbyusingthetouchpad. YoucanaddcalipersbypressingtheCaliperskey.Youcanhavemultiplesetsofcalipersand canswitchfromonesettoanother,repositioningthemasneeded.Eachsetshowsthe measurementresult.Theactivecalipersandmeasurementresultarehighlightedgreen.A measurementiscompletewhenyoufinishmovingitscalipers. Foranaccuratemeasurement,accurateplacementofcalipersisessential. M e a s u r e m e n t s Chapter 4: Measurements 33 To switch the active calipers

Dooneofthefollowing:

Toswitchtheactivecaliperwithinaset,click. Toswitchtheactiveset,pressSwitch. To delete or edit a measurement

Withthemeasurementactive(highlighted),dooneofthefollowing:

Todelete,presstheDeleteknob. Toedit,usethetouchpadtomovethecalipers. To improve precision of caliper placement

Doanyofthefollowing:

Adjustthedisplayformaximumsharpness. Useleadingedges(closesttothetransducer)orbordersforstartingandstoppingpoints. Maintainaconsistenttransducerorientationforeachtypeofmeasurement. Makesurethattheareaofinterestfillsasmuchofthescreenaspossible. Minimizethedepth,orzoom. Distance measurements Distanceismeasuredincm. To measure distance 1 Onafrozenimage,pressCalipers. Apairofcalipersappears,connectedbyadottedline. 2 Usingthetouchpad,positionthefirstcaliper,andthenclick. Theothercaliperbecomesactive. 3 Usingthetouchpad,positiontheothercaliper. Ifyoumovethecalipersclosetogether,theyshrinkandthedottedlinedisappears. Tosavetheimagewiththemeasurementsdisplayed,seeTosaveanimageonpage 28. 34 Area and circumference measurements Areaandcircumferencemeasurementsuseanellipsewithcalipers.Youcanmeasurethe following:

Areaincm2 Circumferenceincm To measure area or circumference 1 Onafrozenimage,pressCalipers. 2 PressEllipse. Note: Ifyouexceedtheallowednumberofmeasurements,Ellipseisnotavailable. 3 Usethetouchpadtoadjustthesizeandpositionoftheellipse.Clickingtogglesbetween positionandsize. Tosavetheimagewiththemeasurementsdisplayed,seeTosaveanimageonpage 28. Measurement accuracy Themeasurementsprovidedbythesystemdonotdefineaspecificphysiologicaloranatomical parameter.Rather,themeasurementsareofaphysicalpropertysuchasdistanceforevaluation bytheclinician.Theaccuracyvaluesrequirethatyoucanplacethecalipersoveronepixel.The valuesdonotincludeacousticanomaliesofthebody. The2Dlineardistancemeasurementresultsaredisplayedincentimeterswithoneplacepast thedecimalpoint,ifthemeasurementistenorgreater;twoplacespastthedecimalpoint,ifthe measurementislessthanten. Thelineardistancemeasurementcomponentshavetheaccuracyandrangeshowninthe followingtables. M e a s u r e m e n t s Chapter 4: Measurements 35 Table 1: 2D Measurement Accuracy and Range 2D Measure Accuracy and Range System Tolerancea Accuracy By Test Methodb Range (cm) Axial Distance Lateral Distance Diagonal Distance Areac Circumferenced Acquisition Phantom 0-26 cm Acquisition Phantom 0-35 cm Acquisition Phantom 0-44 cm Acquisition Phantom 0.01-720 cm2 Acquisition Phantom 0.01-96 cm

< 2% plus 1% of full scale

< 2% plus 1% of full scale

< 2% plus 1% of full scale

< 4% plus (2% of full scale/smallest dimension) * 100 plus 0.5%

< 3% plus (1.4%

of full scale/

smallest dimension) * 100 plus 0.5%

a.Full scale for distance implies the maximum depth of the image. b.An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. c.The area accuracy is defined using the following equation:

% tolerance = ((1 + lateral error) * (1 + axial error) 1) * 100 + 0.5%. d.The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following equation:

% tolerance = (

(maximum of 2 errors) * 100) + 0.5%. 2 Sources of measurement errors Ingeneral,twotypesoferrorscanbeintroducedintothemeasurement:

Acquisition Error Includeserrorsintroducedbytheultrasoundsystemelectronicsrelatingto signalacquisition,signalconversion,andsignalprocessingfordisplay.Additionally, computationalanddisplayerrorsareintroducedbythegenerationofthepixelscalefactor, applicationofthatfactortothecaliperpositionsonthescreen,andthemeasurementdisplay. Algorithmic Error Theerrorintroducedbymeasurements,whichareinputtohigherorder calculations.Thiserrorisassociatedwithfloatingpointversusintegertypemath,whichis subjecttoerrorsintroducedbyroundingversustruncatingresultsfordisplayofagivenlevel ofsignificantdigitinthecalculation. 36 Chapter 5: Troubleshooting and Maintenance Thischaptercontainsinformationtohelpcorrectproblemswithsystemoperation,toentera softwarelicense,andtotakepropercareofthesystem,transducer,andaccessories. Troubleshooting Ifyouencounterdifficultywiththesystem,usethefollowingtabletohelptroubleshootthe problem.Iftheproblempersists,contactSonoSiteTechnicalSupport.(SeeSonoSiteTechnical Supportonpage viii.) Troubleshooting Symptom Solution System does not turn on. System image quality is poor. No CPD image. No Color image. Print does not work. DVD recorder does not record. System does not recognize the transducer. A maintenance icon appears on the system screen. Check all power connections. Remove the DC input connector and battery, wait 10 seconds, and then reinstall them. Ensure that the battery is charged. Adjust the LCD screen to improve viewing angle. Adjust the brightness. Adjust the gain. Adjust the gain. Adjust the gain or the scale. Select the printer on the Connectivity setup page. See To configure the system for a printer on page 18. Check the printer connections. Ensure that the printer is turned on and set up properly. See the printer manufacturers instructions, if necessary. Check the DVD recorder connections. Ensure that the DVD recorder is turned on and set up properly. See the applicable SonoSite accessory user guide and the manufacturers instructions. Disconnect and reconnect the transducer. System maintenance may be required. Record the number in parentheses on the C: line and contact SonoSite or your SonoSite representative. Chapter 5: Troubleshooting and Maintenance 37 T r o u b l e s h o o t i n g Software licensing SonoSitesoftwareiscontrolledbyalicensekey.Afteryouinstallnewsoftware,thesystem promptsyouforalicensekey.Youmustobtainonekeyforeachsystemortransducerthatuses thesoftware. Thesoftwarewilloperateforashorttime(thegraceperiod)withoutalicensekey.Duringthe graceperiod,allsystemfunctionsareavailable.Afterthegraceperiod,thesystemisnotusable untilyouenteravalidlicensekey.Graceperiodtimeisnotusedwhilethesystemisoffor asleep.Graceperiodtimeremainingappearsonthelicenseupdatescreen. Caution:

After the grace period expires, all system functions except licensing are unavailable until a valid license key is entered. Toobtainalicensekeyforyoursoftware,contactSonoSiteTechnicalSupport.(SeeSonoSite TechnicalSupportonpage viii.)Youneedtoprovidethefollowinginformation.(SeeSystem Informationsetuponpage 20.) Software License Key Information System Software Transducer Software Name of institution installing the upgrade Name of institution installing the upgrade Serial number (on bottom of system) Transducer serial number ARM version Transducer part number (REF) or model number (for example, C60x) PCBA serial number Transducer bundle version Afteryouobtainalicensekey,youmustenteritintothesystem. To enter a license key 1 Turnonthesystem. Thelicenseupdatescreenappears. 2 EnterthelicensekeyintheEnter license numberfield. 3 SelectDoneonscreen. Ifyouenteredavalidlicensekeybutthelicenseupdatescreenappears,verifythatyou enteredthelicensekeycorrectly.Ifthelicenseupdatescreenstillappears,contactSonoSite TechnicalSupport.(SeeSonoSiteTechnicalSupportonpage viii.) 38 Maintenance Usetherecommendationsinthissectionwhencleaningordisinfectingyourultrasound system,transducer,andaccessories.Usethecleaningrecommendationsintheperipheral manufacturersinstructionswhencleaningordisinfectingyourperipherals. Noperiodicorpreventivemaintenanceisrequiredforthesystem,transducer,oraccessories otherthancleaninganddisinfectingthetransduceraftereveryuse.(SeeCleaningand disinfectingtransducersonpage 41.)Therearenointernalcomponentsthatrequireperiodic testingorcalibration.Allmaintenancerequirementsaredescribedinthischapterandinthe ultrasoundsystemservicemanual.Performingmaintenanceproceduresnotdescribedinthe userguideorservicemanualmayvoidtheproductwarranty. ContactSonoSiteTechnicalSupportforanymaintenancequestions.(SeeSonoSiteTechnical Supportonpage viii.) WARNING:

Disinfectants and cleaning methods listed are recommended by SonoSite for compatibility with product materials, not for biological effectiveness. Refer to the disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses. The level of disinfection required for a device is dictated by the type of tissue it will contact during use. To avoid infection, ensure that the disinfectant type is appropriate for the equipment. For information, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology (APIC) and the U.S. Food and Drug Administration (FDA). To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure. Caution:

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. T r o u b l e s h o o t i n g Chapter 5: Troubleshooting and Maintenance 39 Cleaning and disinfecting the ultrasound system Theexteriorsurfaceoftheultrasoundsystemandtheaccessoriescanbecleanedand disinfectedusingarecommendedcleanerordisinfectant.SeeTable 1,Disinfectants CompatiblewithSystemandTransducersonpage 44. WARNING:

To avoid electrical shock, before cleaning, disconnect the system from the power supply or remove it from the stand. To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures. To avoid infection, ensure that the solution expiration date has not passed. To avoid infection, the level of disinfection required for a product is dictated by the type of tissue it contacts during use. Ensure that the solution strength and duration of contact are appropriate for the equipment. For information, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology (APIC) and FDA. Caution:

Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may cause solution to leak into the system, damaging the system and voiding the warranty. Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since these will damage the exterior surfaces. Use only recommended cleaners or disinfectants on system surfaces. Immersion-type disinfectants are not approved for use on system surfaces. When you clean the system, ensure that the solution does not get inside the system controls or the battery compartment. Do not scratch the LCD screen. To clean the LCD screen

Dampenaclean,nonabrasive,cottonclothwithanethanolicbasedliquidcleaner,andwipe thescreenclean. Applythecleanertotheclothratherthanthesurfaceofthescreen. To clean and disinfect system surfaces 1 Turnoffthesystem. 2 Disconnectthesystemfromthepowersupply,orremoveitfromthestand. 3 Cleantheexteriorsurfacesusingasoftclothlightlydampenedinamildsoapordetergent cleaningsolutiontoremoveanyparticulatematterorbodyfluids. Applythesolutiontotheclothratherthanthesurface. 40 4 Mixthedisinfectantsolutioncompatiblewiththesystem,followingdisinfectantlabel instructionsforsolutionstrengthsanddisinfectantcontactduration. 5 Wipesurfaceswiththedisinfectantsolution. 6 Airdryortoweldrywithacleancloth. Cleaning and disinfecting transducers Todisinfectthetransduceranditscable,usetheimmersionmethodorthewipemethod. Immersibletransducerscanbedisinfectedonlyiftheproductlabelingindicatestheycanbe usedwithanimmersionmethod. SeeTable 1,DisinfectantsCompatiblewithSystemandTransducersonpage 44. WARNING:

To avoid electrical shock, before cleaning, disconnect the transducer from the system. To avoid injury, always use protective eyewear and gloves when performing cleaning and disinfecting procedures. To avoid infection, ensure that the solution expiration date has not passed. To avoid infection, the level of disinfection required for a transducer is dictated by the type of tissue it contacts during use. Ensure that the solution strength and duration of contact are appropriate for the equipment. SonoSite tests products for compatibility of materials only. SonoSite does not test for biological effectiveness. For information, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology (APIC) and FDA. Caution:

Transducers must be cleaned after every use. Cleaning transducers is necessary prior to effective disinfection. Ensure that you follow the manufacturer's instructions when using disinfectants. Do not use a surgeon's brush when cleaning transducers. Even the use of soft brushes can damage a transducer. Use a soft cloth. Using a non-recommended cleaning or disinfection solution, incorrect solution strength, or immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty. Do not allow cleaning solution or disinfectant into the transducer connector. Do not allow disinfectant to contact metal surfaces. Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces. Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty. T r o u b l e s h o o t i n g Chapter 5: Troubleshooting and Maintenance 41 To clean and disinfect a transducer (wipe method) 1 Disconnectthetransducerfromthesystem. 2 Removeanytransducersheath. 3 Cleanthesurfaceusingasoftclothlightlydampenedinamildsoapordetergentcleaning solutiontoremoveanyparticulatematterorbodyfluids. Applythesolutiontotheclothratherthanthesurface. 4 Rinsewithwaterorwipewithwaterdampenedcloth,thenwipewithadrycloth. 5 Mixthedisinfectantsolutioncompatiblewiththetransducer,followingdisinfectantlabel instructionsforsolutionstrengthsanddisinfectantcontactduration. 6 Wipesurfaceswiththedisinfectantsolution. 7 Airdryortoweldrywithacleancloth. 8 Examinethetransducerandcablefordamagesuchascracks,splitting,orfluidleaks. Ifdamageisevident,discontinueuseofthetransducer,andcontactSonoSiteoryourlocal representative. To clean and disinfect a transducer (immersion method) 1 Disconnectthetransducerfromthesystem. 2 Removeanytransducersheath. 3 Cleanthesurfaceusingasoftclothlightlydampenedinamildsoaporcompatiblecleaning solutiontoremoveanyparticulatematterorbodyfluids. Applythesolutiontotheclothratherthanthesurface. 4 Rinsewithwaterorawipewithwaterdampenedcloth,andthenwipewithadrycloth. 5 Mixthedisinfectantsolutioncompatiblewiththetransducer,followingdisinfectantlabel instructionsforsolutionstrengthsanddisinfectantcontactduration. 6 Immersethetransducerintothedisinfectionsolutionnotmorethan1218 inches(3146 cm) fromthepointwherethecableenterstheconnector. Followtheinstructionsonthedisinfectantlabelforthedurationofthetransducer immersion. 7 Usingtheinstructionsonthedisinfectantlabel,rinsetothepointofthepreviousimmersion, andthenairdryortoweldrywithacleancloth. 8 Examinethetransducerandcablefordamagesuchascracks,splitting,orfluidleaks. Ifdamageisevident,discontinueuseofthetransducer,andcontactSonoSiteoryourlocal representative. 42 Cleaning and disinfecting the battery Caution:

To avoid damaging the battery, do not allow cleaning solution or disinfectant to come in contact with the battery terminals. To clean and disinfect a battery (wipe method) 1 Removethebatteryfromthesystem. 2 Cleanthesurfaceusingasoftclothlightlydampenedinamildsoapordetergentcleaning solution. Applythesolutiontotheclothratherthanthesurface. 3 Wipethesurfaceswiththedisinfectionsolution.Theracidedisinfectantisrecommended. 4 Airdryortoweldrywithacleancloth. T r o u b l e s h o o t i n g Chapter 5: Troubleshooting and Maintenance 43 4 4 Table 1 does not have the following regulatory information for disinfectants:

EPA Registration FDA 510(k) clearance (liquid sterilant, high level disinfectant) CE approval Prior to use, confirm that the regulatory status of the disinfectant is appropriate for your jurisdiction and use. Seewww.sonosite.comforupdatedcleaninganddisinfectantinformation.ClickQuick Link,andthenclick Documentation. Table 1: Disinfectants Compatible with System and Transducers Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Liquid Gluteraldehyde AbcoCide 14 Accel Wipes Accel Plus Accel TB Aidal Plus Alkacide Alkazyme Anioxy-Twin Aquatabs (1000) USA CAN CAN CAN AUS FRA FRA FRA IRL Wipe Wipe Wipe Liquid Liquid Liquid Liquid Tablet Aquatabs (2000) IRL Tablet Hydrogen Peroxide Hydrogen Peroxide Hydrogen Peroxide Gluteraldehyde Gluteraldehyde Quat. Ammonia Peracetic Acid Sodium Dichloroisocyanurate Sodium Dichloroisocyanurate A A N N A A A N A A A A N N A A A N N N A A N N A A A N A A U U U U U U U U U U Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Aquatabs (5000) IRL Tablet Sodium Dichloroisocyanurate Anioxyde 1000 Ascend Asepti-HB Asepti-Steryl Asepti-Wipes Bacillocid rasant Banicide Bleach Cavicide Caviwipes Chlor-Clean FRA USA USA USA USA DEU USA USA USA USA GBR Cidalkan Lingettes FRA Cidex Cidex OPA Cidex Plus Cleanisept Clorox Wipes USA USA USA DEU USA Liquid Liquid Liquid Spray Wipe Liquid Liquid Liquid Liquid Wipes Liquid Wipes Liquid Liquid Liquid Wipes Wipes Peracetic Acid Quat Ammonia Quat Ammonia Ethanol Propanol (Isopropyl Alcohol Glut./Quat. Ammonia Gluteraldehyde NaCl Hypochlorite Isopropyl Isopropanol Sodium Dichloroisocyanurate Ethyl Alcohol Gluteraldehyde Ortho-phthaldehyde Gluteraldehyde Quat Ammonia Isopropanol N N A A A A A A A A A A A A A A A A N N A A A A A U A A A N A A A A A A N N A A A A A A A A N A U A A A A A U U U U N A U U U U U U U A U A A U C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 4 5 Troubleshooting 4 6 Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Control III Coverage Spray DentaSept USA USA FRA Denatured Alcohol USA DisCide Wipes DisOPA Dispatch Dynacide PA End-Bac II USA JPN USA FRA USA Endozime AW Plus FRA Envirocide Enzol Expose Gigasept AF Gigasept FF USA USA USA DEU DEU Gluteraldehyde SDS USA Hexanios Hi Tor Plus Hibiclens FRA USA USA Liquid Quat. Ammonia Spray Liquid Liquid Wipes Liquid Spray Liquid Liquid Liquid Liquid Quat. Ammonia Quat. Ammonia Ethanol Isopropyl Alcohol Ortho-phthaldehyde NaCl Hypochlorite Peracetic Acid Quat. Ammonia Propanol Isopropyl Cleaner Ethylene Glycol Liquid Liquid Liquid Liquid Liquid Isopropyl Quat. Ammonia Bersteinsaure Gluteraldehyde Polyhexanide/Quat. Ammonia Liquid Chloride Cleaner Chlorhexidine A A N N A A A A A A A A A A N A A A A A A N N A A A A A A U A A A N U A A A N N N N A A A A A A N A A A N A A N A U N U U U U U U N U U U U U U U U U U Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Spray Liquid Liquid Liquid Liquid Liquid Hydrogen Peroxide Alcohol Propanol Gluteraldehyde Gluteraldehyde Ethanol/Propanol Alkyl/Chloride O-phenylphenol Ethanol O-phenylphenol Isopropanol O-phenylphenol Gluteraldehyde Gluteraldehyde Cleaner Propylene Glycol Liquid Ammonium Chloride Wipe Spray Spray Ethanol/Propanol Alcohol/Biguanide O-phenylphenol Liquid Hydrogen Peroxide A N A A N A N A N A A A A A A A A A N N A N A U N A N A N N A U A A A A A A N N A N A A N A N A N A N A A A A A A A N N U U U U U U U U N U A U U U U U U U U U Hydrogen Peroxide USA Isopropanol Alcohol ALL DEU DEU DEU DEU USA USA USA USA USA USA USA USA USA DEU DEU FRA USA CAN Kodan Tcher Kohrsolin ff Korsolex basic Korsolex extra Lem-O-Quat LpHse Lysol Lysol IC Madacide 1 Matar MetriCide 14 MetriCide 28 MetriZyme Mikrobak forte Mikrozid Wipes Nuclean Precise Prevention Troubleshooting C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 4 7 4 8 Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Ruthless Sagrosept Wipe Salvanios pH 7 Sani-Cloth HB Sani-Cloth Plus Sekusept Sklar Sporicidin Sporicidin Wipes Staphene Steranios Super Sani-Cloth T-Spray T-Spray II TASK 105 TBQ Theracide Plus Theracide Plus Wipes USA DEU FRA USA USA DEU USA USA USA USA FRA USA USA USA USA USA USA USA Spray Wipe Quat. Ammonia Propanol Liquid Quat. Ammonia Wipe Wipe Liquid Liquid Liquid Wipe Spray Quat. Ammonia Quat. Ammonia Gluteraldehyde Isopropanol Phenol Phenol Ethanol Liquid Gluteraldehyde Wipe Spray Spray Spray Liquid Liquid Wipe Isopropyl Alcohol Quat. Ammonia Alkyl/Chloride Quat. Ammonia Quat. Ammonia Quat. Ammonia Quat. Ammonia Tor USA Liquid Quat. Ammonia A A A A A A A A A A A N A A A A A A A A A A A A A A A A N A N A A A A A A A N A A N A A N A A A A N N A A A A A N U U U A A U U N A U U N N U U U U A U Table 1: Disinfectants Compatible with System and Transducers (Continued) Disinfection and Cleaning Solutions Country of Origin Type Active Ingredient C60x/ICTx/

L38x/P21x HFL38x C11x/

L25x System Surfaces Transeptic Tristel Tristel Wipes Vesphene II Virex II 256 Virex TB Virox 5 Virufen Wavicide -01 Wavicide -06 Wex-Cide USA GBR GBR USA USA USA CAN FRA USA USA USA Cleaner Alcohol Liquid Chlorine Dioxide Wipe Liquid Liquid Liquid Wipe Liquid Liquid Liquid Liquid Chlorine Dioxide Sodium/

o-Phenylphenate Ammonium Chloride Quat. Ammonia Hydrogen Peroxide Alkyl Ammonium Chloride Gluteraldehyde Gluteraldehyde O-phenylphenol N A N A A A A A N A A A = Acceptable N = Not acceptable (Do not use) U = Untested (Do not use) N A N A A A A A N A A N A N A A N A A N A A U U N U U N U U U U U C h a p t e r 5

l T r o u b e s h o o t i n g a n d M a n t e n a n c e i 4 9 Troubleshooting 50 Chapter 6: Safety Thischaptercontainsinformationrequiredbyregulatoryagencies,includinginformation abouttheALARA(aslowasreasonablyachievable)principle,theoutputdisplaystandard, acousticpowerandintensitytables,andothersafetyinformation.Theinformationappliesto theultrasoundsystem,transducer,accessories,andperipherals. S a f e t y Ergonomic safety Thesehealthyscanningguidelinesareintendedtoassistyouinthecomfortandeffectiveuse ofyourultrasoundsystem. WARNING:

To prevent musculoskeletal disorders, follow the guidelines in this section. Use of an ultrasound system may be linked to musculoskeletal disordersa,b,c. Use of an ultrasound system is defined as the physical interaction among the operator, the ultrasound system, and the transducer. When using an ultrasound system, as with many similar physical activities, you may experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back, or other parts of your body. However, if you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified health professional. Symptoms such as these can be linked with musculoskeletal disorders (MSDs). MSDs can be painful and may result in potentially disabling injuries to the nerves, muscles, tendons, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and tendonitis. While researchers are not able to definitively answer many questions about MSDs, there is a general agreement that certain factors are associated with their occurrence including: preexisting medical and physical conditions, overall health, equipment and body position while doing work, frequency of work, duration of work, and other physical activities that may facilitate the onset of MSDsd. This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDse,f. a.Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. Work-related Musculoskeletal Complaints in Sonologists. Occupational Environmental Medicine. 41:11 (1999), 981-988. b.Craig, M. Sonography: An Occupational Hazard? Journal of Diagnostic Medical Sonography. 3 (1985), 121-125. c.Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. Musculoskeletal Pain in Cardiac Ultrasonographers:

Results of a Random Survey. Journal of American Society of Echocardiography. (May1997), 357-362. d.Wihlidal, L.M. and S. Kumar. An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta. International Journal of Industrial Ergonomics. 19 (1997), 205-216. Chapter 6: Safety 51 e.Habes, D.J. and S. Baron. Health Hazard Report 99-0093-2749. University of Medicine and Dentistry of New Jersey. (1999). f.Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers. Journal of Medicine. 35:6 (1993), 605-610. Position the system Promote comfortable shoulder, arm, and hand postures Useastandtosupporttheweightoftheultrasoundsystem. Minimize eye and neck strain Whentheexamorprocedureallows,positionthesystemwithinreach. Adjusttheangleofthesystemanddisplaytominimizeglarefromoverheadoroutside lighting. Ifusingastand,adjustitsheightsothatthedisplayisatorslightlybeloweyelevel. Position yourself Support your back during an exam Useachairthathassupportforyourlowerback,thatadjuststoyourworksurfaceheight, thatpromotesanaturalbodyposture,andthatallowsforquickheightadjustments. Alwayssitorstandinanuprightmanner.Avoidbendingorstooping. Minimize reaching and twisting Useabedthatisheightadjustable. Positionthepatientasclosetoyouaspossible. Faceforward.Avoidtwistingyourheadorbody. Moveyourentirebodyfronttoback,andpositionyourscanningarmnexttoorslightlyin frontofyou. Standfordifficultexamstominimizereaching. Promote comfortable shoulder and arm postures Keepyourelbowclosetoyourside. Relaxyourshouldersinalevelposition. Supportyourarmusingasupportcushionorpillow,orrestitonthebed. Minimize neck bending and twisting Positiontheultrasoundsystemdirectlyinfrontofyou. 52 S a f e t y Promote comfortable hand, wrist, and finger postures Holdthetransducerlightlyinyourfingers. Minimizethepressureappliedonthepatient. Keepyourwristinastraightposition. Take breaks, exercise, and vary activities Minimizingscanningtimeandtakingbreakscaneffectivelyallowyourbodytorecoverfrom physicalactivityandhelpyouavoidMSDs.Someultrasoundtasksmayrequirelongeror morefrequentbreaks.Onewayoftakingabreakistostopandrelax.However,simply changingtaskscanhelpsomemusclegroupsrelaxwhileothersremainorbecomeactive. Workefficientlybyusingthesoftwareandhardwarefeaturescorrectly. Keepmoving.Avoidsustainingthesameposturebyvaryingyourhead,neck,body,arm, andlegpositions. Targetedexercisescanstrengthenmusclegroups,whichmayhelpyouavoidMSDs.Contact aqualifiedhealthprofessionaltodeterminestretchesandexercisesthatarerightforyou. Electrical safety classification Class I equipment Internally powered equipment Ultrasound system powered from power supply or part of the S Series stand. Ultrasound system not connected to the power supply

(battery only) Type BF applied parts Ultrasound transducers IPX-7 (watertight equipment) Ultrasound transducers Non AP/APG Ultrasound system power supply, S Series stand, and peripherals. Equipment is not suitable for use in the presence of flammable anaesthetics. Electrical safety ThissystemmeetsEN606011,ClassI/internallypoweredequipmentrequirementsandType BFisolatedpatientappliedpartssafetyrequirements. Thissystemcomplieswiththeapplicablemedicalequipmentrequirementspublishedinthe CanadianStandardsAssociation(CSA),EuropeanNormHarmonizedStandards,and UnderwritersLaboratories(UL)safetystandards.SeeChapter 7,Specifications. Chapter 6: Safety 53 Formaximumsafetyobservethefollowingwarningsandcautions. WARNING:

To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the patient. Under certain circumstances, the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system. This does not include the transducer face. To avoid discomfort or minor risk of operator injury when handling the transducer connector, the system should not be operated for more than 60 minutes continuously in a live-scan mode (as opposed to freeze or sleep modes). To avoid the risk of electrical shock or injury, do not open the system enclosures. All internal adjustments and replacements, except battery replacement, must be made by a qualified technician. To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. Explosion can result. To avoid the risk of electrical shock, use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent. The grounding wire must not be removed or defeated. To avoid the risk of electrical shock, when using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt, operate the system on battery power only without using the power supply. To avoid the risk of electrical shock, do not connect the systems power supply or the S Stands auxiliary mains outlet receptacles to an MPSO or extension cord. To avoid the risk of electrical shock, before using the transducer, inspect the transducer face, housing, and cable. Do not use the transducer if the transducer or cable is damaged. To avoid the risk of electrical shock, always disconnect the power supply from the system before cleaning the system. To avoid the risk of electrical shock, do not use any transducer that has been immersed beyond the specified cleaning or disinfection level. See Chapter 5, Troubleshooting and Maintenance. To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC power cord, and plug on a regular basis. Ensure they are not damaged. To avoid the risk of electrical shock and fire hazard, the power cord set that connects the power supply of the ultrasound system or S Series stand to mains power must only be used with the power supply or S Series stand, and cannot be used to connect other devices to mains power. 54 WARNING:

S a f e t y To avoid the risk of electrical shock, use only accessories and peripherals recommended by SonoSite, including the power supply. Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommend by SonoSite. To avoid the risk of electrical shock, inspect cables and power cords used within the system on a regular basis for damage. To avoid the risk of electrical shock to the patient/subject, do not touch the system battery contacts while simultaneously touching a patient/subject. To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse. To avoid possible electrical shock or electromagnetic interference, verify proper operation and compliance with relevant safety standards for all equipment before clinical use. Connecting additional equipment to the ultrasound system constitutes configuring a medical system. SonoSite recommends verifying that the system, all combinations of equipment, and accessories connected to the ultrasound system comply with JACHO installation requirements and/or safety standards such as AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic compatibility standard IEC 60601-1-2 (Electromagnetic compatibility), and are certified according to IEC Standard 60950 (Information Technology Equipment (ITE)). Caution:

Do not use the system if an error message appears on the image display: note the error code; call SonoSite or your local representative; turn off the system by pressing and holding the power key until the system powers down. To avoid increasing the system and transducer connector temperature, do not block the airflow to the ventilation holes on the back of the system. Chapter 6: Safety 55 Equipment safety Toprotectyourultrasoundsystem,transducer,andaccessories,followtheseprecautions. Caution:

Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 5, Troubleshooting and Maintenance. Do not submerge the transducer connector in solution. The cable is not liquid-tight beyond the transducer connector/cable interface. Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system. Remove the battery from the system if the system is not likely to be used for some time. Do not spill liquid on the system. Battery safety Topreventthebatteryfrombursting,igniting,oremittingfumesandcausingpersonalinjury orequipmentdamage,observethefollowingprecautions. WARNING:

The battery has a safety device. Do not disassemble or alter the battery. Charge the batteries only when the ambient temperature is between 0 and 40C

(32 and 104F). Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects. Do not heat the battery or discard it in a fire. Do not expose the battery to temperatures over 60C (140F). Keep it away from fire and other heat sources. Do not charge the battery near a heat source, such as a fire or heater. Do not leave the battery in direct sunlight. Do not pierce the battery with a sharp object, hit it, or step on it. Do not use a damaged battery. Do not solder a battery. The polarity of the battery terminals are fixed and cannot be switched or reversed. Do not force the battery into the system. Do not connect the battery to an electrical power outlet. 56 WARNING:

Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles. If the battery leaks or emits an odor, remove it from all possible flammable sources. S a f e t y Caution:

To avoid the battery bursting, igniting, or emitting fumes from the battery and causing equipment damage, observe the following precautions:

Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave oven or pressurized container. If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult SonoSite or your local representative. Store the battery between -20C (-4F) and 60C (140F). Use only SonoSite batteries. Do not use or charge the battery with non-SonoSite equipment. Only charge the battery with the system. Clinical safety Observethefollowingprecautionsrelatedtoclinicalsafety. WARNING:

Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis. To avoid the risk of a burn hazard, do not use the transducer with high frequency surgical equipment. Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection. Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use. Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber. Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle and follow the prudent use information concerning MI and TI. Chapter 6: Safety 57 WARNING:

SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz. Some SonoSite transducers are approved for intraoperative applications if a market-cleared sheath is used. Electromagnetic compatibility Theultrasoundsystemhasbeentestedandfoundtocomplywiththeelectromagnetic compatibility(EMC)limitsformedicaldevicestoIEC6060112:2001.Theselimitsaredesigned toprovidereasonableprotectionagainstharmfulinterferenceinatypicalmedicalinstallation. Caution:

Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the ultrasound system. Evidence of disruption may include image degradation or distortion, erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs, survey the site to determine the source of disruption, and take the following actions to eliminate the source(s). Turn equipment in the vicinity off and on to isolate disruptive equipment. Relocate or re-orient interfering equipment. Manage use of frequencies close to ultrasound system frequencies. Remove devices that are highly susceptible to EMI. Lower power from internal sources within facility control (such as paging Increase distance between interfering equipment and your ultrasound system. systems). Label devices susceptible to EMI. Educate clinical staff to recognize potential EMI-related problems. Eliminate or reduce EMI with technical solutions (such as shielding). Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI. Share relevant EMI information with others, particularly when evaluating new equipment purchases which may generate EMI. Purchase medical devices that comply with IEC 60601-1-2 EMC Standards. 58 Caution:

To avoid the risk of increased electromagnetic emissions or decreased immunity, use only accessories and peripherals recommended by SonoSite. Connection of accessories and peripherals not recommended by SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite. See the SonoSite accessories user guide. Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats. S a f e t y Manufacturers declaration Table 1andTable 2documenttheintendeduseenvironmentandEMCcompliancelevelsofthe system.Formaximumperformance,ensurethatthesystemisusedintheenvironments describedinthistable. Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Table 1: Manufacturers Declaration - Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment The SonoSite 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. The SonoSite ultrasound system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes. RF emissions ClSPR 11 RF emissions ClSPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Group 1 Class A Class A Complies Chapter 6: Safety 59 Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Table 2: Manufacturers Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge (ESD) IEC 61000-4-2 2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air 2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air Electrical fast Transient burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2KV on the mains 1KV on signal lines 2KV on the mains 1KV on signal lines 0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

>5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

>5% UT

(>95% dip in UT) for 5s 0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

>5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

>5% UT

(>95% dip in UT) for 5s Electromagnetic Environment Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the SonoSite ultrasound system requires continued operation during power mains interruptions, it is recommended that the SonoSite ultrasound system be powered from an uninterruptible power supply or a battery. 60 Table 2: Manufacturers Declaration - Electromagnetic Immunity (Continued) Immunity Test IEC 60601 Test Level Compliance Level 3 A/m 3 A/m Power Frequency Magnetic Field IEC 61000-4-8 Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 Vim 80 MHz to 2.5 GHz 3 V/m S a f e t y Electromagnetic Environment If image distortion occurs, it may be necessary to position the SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low. Portable and mobile RF communications equipment should be used no closer to any part of the SonoSite ultrasound system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance d = 1.2 P P d = 1.2 80 MHz to 800 MHz P d = 2.3 800 MHz to 2,5 GHz Where 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). Chapter 6: Safety 61 Table 2: Manufacturers Declaration - Electromagnetic Immunity (Continued) Immunity Test IEC 60601 Test Level Compliance Level Radiated RF IEC 61000-4-3

(continued) Electromagnetic Environment 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:

(IEC 60417 No. 417-IEC-5140:

Source of non-ionizing radiation) Note: UT is the AC mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a.Field 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 SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. ALARA principle ALARAistheguidingprinciplefortheuseofdiagnosticultrasound.Sonographersandother qualifiedultrasoundusers,usinggoodjudgmentandinsight,determinetheexposurethatis aslowasreasonablyachievable.Therearenosetrulestodeterminethecorrectexposurefor everysituation.Thequalifiedultrasounduserdeterminesthemostappropriatewaytokeep exposurelowandbioeffectstoaminimum,whileobtainingadiagnosticexamination. Athoroughknowledgeoftheimagingmodes,transducercapability,systemsetupand scanningtechniqueisnecessary.Theimagingmodedeterminesthenatureoftheultrasound beam.Astationarybeamresultsinamoreconcentratedexposurethanascannedbeam,which spreadsthatexposureoverthatarea.Thetransducercapabilitydependsuponthefrequency, 62 penetration,resolution,andfieldofview.Thedefaultsystempresetsareresetatthestartof eachnewpatient.Itisthescanningtechniqueofthequalifiedultrasounduseralongwith patientvariabilitythatdeterminesthesystemsettingsthroughouttheexam. ThevariableswhichaffectthewaythequalifiedultrasounduserimplementstheALARA principleinclude:patientbodysize,locationofthebonerelativetothefocalpoint,attenuation inthebody,andultrasoundexposuretime.Exposuretimeisanespeciallyusefulvariable, becausethequalifiedultrasoundusercancontrolit.Theabilitytolimittheexposureovertime supportstheALARAprinciple. S a f e t y Applying ALARA Thesystemimagingmodeselectedbythequalifiedultrasounduserisdeterminedbythe diagnosticinformationrequired.2Dimagingprovidesanatomicalinformation;CPDimaging providesinformationabouttheenergyoramplitudestrengthoftheDopplersignalovertime atagivenanatomicallocationandisusedfordetectingthepresenceofbloodflow;Color imagingprovidesinformationabouttheenergyoramplitudestrengthoftheDopplersignal overtimeatagivenanatomicallocationandisusedfordetectingthepresence,velocity,and directionofbloodflow;TissueHarmonicImaginguseshigherreceivedfrequenciestoreduce clutter,artifact,andimproveresolutiononthe2Dimage.Understandingthenatureofthe imagingmodeusedallowsthequalifiedultrasoundusertoapplytheALARAprinciple. Prudentuseofultrasoundrequiresthatpatientexposuretoultrasoundbelimitedtothelowest ultrasoundoutputfortheshortesttimenecessarytoachieveacceptablediagnosticresults. Decisionsthatsupportprudentusearebasedonthetypeofpatient,examtype,patienthistory, easeordifficultyofobtainingdiagnosticallyusefulinformation,andpotentiallocalized heatingofthepatientduetotransducersurfacetemperature. Thesystemhasbeendesignedtoensurethattemperatureatthefaceofthetransducerwillnot exceedthelimitsestablishedinSection42ofEN60601237:Particularrequirementforthe safetyofultrasoundmedicaldiagnosticandmonitoringequipment.SeeTransducersurface temperatureriseonpage 68.Intheeventofadevicemalfunction,thereareredundantcontrols thatlimittransducerpower.Thisisaccomplishedbyanelectricaldesignthatlimitsbothpower supplycurrentandvoltagetothetransducer. Thesonographerusesthesystemcontrolstoadjustimagequalityandlimitultrasoundoutput. Thesystemcontrolsaredividedintothreecategoriesrelativetooutput:controlsthatdirectly affectoutput,controlsthatindirectlyaffectoutput,andreceivercontrols. Direct controls Thesystemdoesnotexceedaspatialpeaktemporalaverageintensity(ISPTA)of720 mW/cm2 forallimagingmodes.Themechanicalindex(MI)andthermalindex(TI)mayexceedvalues greaterthan1.0onsometransducersinsomeimagingmodes.OnemaymonitortheMIandTI valuesandadjustthecontrolstoreducethesevalues.SeeGuidelinesforreducingMIandTI onpage 64.Additionally,onemeansformeetingtheALARAprincipleistosettheMIorTI valuestoalowindexvalueandthenmodifyingthisleveluntilasatisfactoryimageorDoppler modeisobtained.FormoreinformationonMIandTI,seeBSEN60601237:2001:AnnexHH. Chapter 6: Safety 63 Indirect controls Thecontrolsthatindirectlyaffectoutputarecontrolsaffectingimagingmode,freeze,and depth.Theimagingmodedeterminesthenatureoftheultrasoundbeam.Tissueattenuationis directlyrelatedtotransducerfrequency.ThehigherthePRF(pulserepetitionfrequency),the moreoutputpulsesoccuroveraperiodoftime. Receiver controls Thereceivercontrolsarethegaincontrols.Receivercontrolsdonotaffectoutput.Theyshould beused,ifpossible,toimproveimagequalitybeforeusingcontrolsthatdirectlyorindirectly affectoutput. Acoustic artifacts Anacousticartifactisinformation,presentorabsentinanimage,thatdoesnotproperly indicatethestructureorflowbeingimaged.Therearehelpfulartifactsthataidindiagnosisand thosethathinderproperinterpretation.Examplesofartifactsinclude:

Shadowing Throughtransmission Aliasing Reverberations Comettails Formoreinformationondetectingandinterpretingacousticartifacts,seethefollowing reference:

Kremkau,FrederickW.DiagnosticUltrasound:PrinciplesandInstruments.7thed.,W.B. SaundersCompany,(Oct.17,2005). Guidelines for reducing MI and TI ThefollowingaregeneralguidelinesforreducingMIorTI.Ifmultipleparametersaregiven, thenthebestresultsmaybeachievedbyminimizingtheseparameterssimultaneously.Insome modeschangingtheseparameterswillnotaffectMIorTI.Changestootherparametersmay alsoresultinMIandTIreductions.PleasenotetheMIorTIreadoutontherightsideofthe LCDscreen. 64 meanstodecreaseorlowersettingofparametertoreduceMIorTI. meanstoraiseorincreasesettingofparametertoreduceMIorTI Table 3: MI Transducer Depth S a f e t y C11x C60x HFL38x ICTx L25x L38x P21x Table 4: TI (TIS, TIC, TIB) Color Power Doppler Settings Transducer Box Width Box Height Box Depth PRF Depth Optimize C11x C60x HFL38x ICTx L25x L38x P21x Exam Gyn Chapter 6: Safety 65 Output display ThesystemmeetstheAIUMoutputdisplaystandardforMIandTI(seelastreferencelistedin Relatedguidancedocumentsbelow).Table 5indicatesforeachtransducerandoperating modewheneithertheTIorMIisgreaterthanorequaltoavalueof1.0,thusrequiringdisplay. Table 5: Cases Where Either a Thermal or Mechanical Index is 1.0 Transducer Model Index C11x/8-5 MI TIC,TIB, or TIS C60x/5-2 MI TIC, TIB, or TIS HFL38x/13-6 MI TIC, TIB, or TIS ICTx/8-5 MI TIC, TIB, or TIS L25x/13-6 MI TIC,TIB, or TIS L38x/10-5 MI TIC, TIB, or TIS P21x/5-1 MI TIC, TIB, or TIS 2D No No Yes No No No No No No No No No Yes Yes CPD/

Color No Yes No No Yes Yes No No No No Yes Yes Yes Yes EvenwhenMIislessthan1.0,thesystemprovidesacontinuousrealtimedisplayofMI wheneveratransducerisoperatedina2Dimagingmode.Theindexisdisplayedinincrements of0.1. ThesystemmeetstheoutputdisplaystandardforTI.AcontinuousrealtimedisplayofTIis providedfortheoperatorwheneveratransducerisoperatedinaCPDorColorimagingmode. Theindexisdisplayedinincrementsof0.1. Thethermalindexconsistsofthreeuserselectableindices,andonlyoneoftheseisdisplayed atanyonetime.InordertodisplayproperlyandmeettheALARAprinciple,theuserselects anappropriateTIbasedonthespecificexambeingperformed.SonoSiteprovidestheAIUM MedicalUltrasoundSafetyreferencewhichcontainsguidanceonhowtodeterminewhichTI isappropriate(seesecondreferencelistedinRelatedguidancedocumentsonpage 67). 66 Mechanical and thermal indices output display accuracy Theaccuracyresultforthemechanicalindex(MI)isstatedstatistically.With90%confidence, 90%ofthemeasuredMIvalueswillbewithin+16%to31%ofthedisplayedMIvalue,or+0.2 ofthedisplayedvalue,whichevervalueislarger. Theaccuracyresultforthethermalindex(TI)isstatedstatistically.With90%confidence,90%

ofthemeasuredTIvalueswillbewithin+26%to50%ofthedisplayedTIvalue,or+0.2ofthe displayedvalue,whichevervalueislarger.Thevaluesequateto+1dBto3dB. Adisplayedvalueof0.0forMIorTImeansthatthecalculatedestimatefortheindexislessthan 0.05. S a f e t y Factors that contribute to display uncertainty Thenetuncertaintyofthedisplayedindicesisderivedbycombiningthequantifieduncertainty fromthreesources;measurementuncertainty,systemandtransducervariability,and engineeringassumptionsandapproximationsmadewhencalculatingthedisplayvalues. Measurementerrorsoftheacousticparameterswhentakingthereferencedataarethemajor sourceoferrorthatcontributestothedisplayuncertainty.Themeasurementerrorisdescribed inAcousticmeasurementprecisionanduncertaintyonpage 79. ThedisplayedMIandTIvaluesarebasedoncalculationsthatuseasetofacousticoutput measurementsthatweremadeusingasinglereferenceultrasoundsystemwithasingle referencetransducerthatisrepresentativeofthepopulationoftransducersofthattype.The referencesystemandtransducerarechosenfromasamplepopulationofsystemsand transducerstakenfromearlyproductionunits,andtheyareselectedbasedonhavingan acousticoutputthatisrepresentativeofthenominalexpectedacousticoutputforall transducer/systemcombinationsthatmightoccur.Ofcourseeverytransducer/system combinationhasitsownuniquecharacteristicacousticoutput,andwillnotmatchthenominal outputonwhichthedisplayestimatesarebased.Thisvariabilitybetweensystemsand transducersintroducesanerrorintodisplayedvalue.Bydoingacousticoutputsampling testingduringproduction,theamountoferrorintroducedbythevariabilityisbounded.The samplingtestingensuresthattheacousticoutputoftransducersandsystemsbeing manufacturedstayswithinaspecifiedrangeofthenominalacousticoutput. Anothersourceoferrorarisesfromtheassumptionsandapproximationsthataremadewhen derivingtheestimatesforthedisplayindices.Chiefamongtheseassumptionsisthatthe acousticoutput,andthusthederiveddisplayindices,arelinearlycorrelatedwiththetransmit drivevoltageofthetransducer.Generally,thisassumptionisverygood,butitisnotexact,and thussomeerrorinthedisplaycanbeattributedtotheassumptionofvoltagelinearity. Related guidance documents InformationforManufacturersSeekingMarketingClearanceofDiagnosticUltrasound SystemsandTransducers,FDA,1997. MedicalUltrasoundSafety,AmericanInstituteofUltrasoundinMedicine(AIUM),1994.(A copyisincludedwitheachsystem.) Chapter 6: Safety 67 AcousticOutputMeasurementStandardforDiagnosticUltrasoundEquipment,NEMA UD22004. AcousticOutputMeasurementandLabelingStandardforDiagnosticUltrasound Equipment,AmericanInstituteofUltrasoundinMedicine,1993. StandardforRealTimeDisplayofThermalandMechanicalAcousticOutputIndiceson DiagnosticUltrasoundEquipment,NEMAUD32004. GuidanceontheinterpretationofTIandMItobeusedtoinformtheoperator,AnnexHH, BSEN60601237reprintedatP05699. Transducer surface temperature rise Table 6andTable 7listthemeasuredsurfacetemperaturerisefromambient*oftransducers usedontheultrasoundsystem.ThetemperaturesweremeasuredinaccordancewithEN 60601237section42wherecontrolsandsettingswerepositionedtogivemaximum temperatures Test1:Thetransducersurfacetemperaturetestontissuemimickingmaterial(TMM)isbased onthefollowingstandard:42.3(a)1,TestMethodB(IEC60601237,Amendment1).Thelimit isa10Crisefromambient,asmeasuredontheTMM. Test2:Thetransducersurfacetemperaturetestinairisbasedonthefollowingstandard:

42.3(a)2(IEC60601237,Amendment1).Thelimitisa27Crisefromambient. Test3:ThetransducersurfacetemperaturetestonTMMisbasedonthefollowingstandard:

42.3(a)1,TestMethodB(IEC60601237,Amendment1).Thelimitisa6Crisefromambient, asmeasuredontheTMM.

*Theambienttemperatureshallbe23C3C. Table 6: Transducer Surface Temperature Rise EN 60601-2-37 (External Use) Test 1 2 C11x 9.2C C60x 9.0C HFL38x L25x 9.5C 9.5C L38x 9.6C P21x 9.0C 19.0C 18.0C 19.0C 18.2C 20.0C 20.0C Table 7: Transducer Surface Temperature Rise IEC 60601-2-37 (Internal Use) Test 3 2 ICTx 5.5C 12.0C 68 Acoustic output measurement Sincetheinitialuseofdiagnosticultrasound,thepossiblehumanbiologicaleffects(bioeffects) fromultrasoundexposurehavebeenstudiedbyvariousscientificandmedicalinstitutions.In October1987,theAmericanInstituteofUltrasoundinMedicine(AIUM)ratifiedareport preparedbyitsBioeffectsCommittee(BioeffectsConsiderationsfortheSafetyofDiagnostic Ultrasound,JUltrasoundMed.,Sept.1988:Vol.7,No.9Supplement),sometimesreferredtoas theStoweReport,whichreviewedavailabledataonpossibleeffectsofultrasoundexposure. AnotherreportBioeffectsandSafetyofDiagnosticUltrasound,datedJanuary28,1993 providesmorecurrentinformation. Theacousticoutputforthisultrasoundsystemhasbeenmeasuredandcalculatedin accordancewiththeAcousticOutputMeasurementStandardforDiagnosticUltrasound Equipment(NEMAUD22004),andtheStandardforRealTimeDisplayofThermaland MechanicalAcousticOutputIndicesonDiagnosticUltrasoundEquipment(NEMA UDe32004). S a f e t y In Situ, derated, and water value intensities Allintensityparametersaremeasuredinwater.Sincewaterdoesnotabsorbacousticenergy, thesewatermeasurementsrepresentaworstcasevalue.Biologicaltissuedoesabsorbacoustic energy.Thetruevalueoftheintensityatanypointdependsontheamount,typeoftissue,and thefrequencyoftheultrasoundpassingthroughthetissue.Theintensityvalueinthetissue, In Situ,hasbeenestimatedbyusingthefollowingformula:

In Situ=Water[e(0.23alf)]

where:

In Situ=In Situintensityvalue Water=Waterintensityvalue e=2.7183 a=attenuationfactor(dB/cm MHz) Attenuationfactor(a)forvarioustissuetypesaregivenbelow:

brain=0.53 heart=0.66 kidney=0.79 liver=0.43 muscle=0.55 l=skinlinetomeasurementdepthincm f=centerfrequencyofthetransducer/system/modecombinationinMHz Chapter 6: Safety 69 Sincetheultrasonicpathduringtheexamislikelytopassthroughvaryinglengthsandtypes oftissue,itisdifficulttoestimatethetrueIn Situintensity.Anattenuationfactorof0.3isused forgeneralreportingpurposes;therefore,theIn Situvaluecommonlyreportedusesthe formula:

In Situ(derated)=Water[e(0.069lf)]

SincethisvalueisnotthetrueIn Situintensity,thetermderatedisusedtoqualify it. Themaximumderatedandthemaximumwatervaluesdonotalwaysoccuratthesame operatingconditions;therefore,thereportedmaximumwaterandderatedvaluesmaynotbe relatedbytheIn Situ(derated)formula.Forexample:amultizonearraytransducerthathas maximumwatervalueintensitiesinitsdeepestzone,butalsohasthesmallestderatingfactor inthatzone.Thesametransducermayhaveitslargestderatedintensityinoneofitsshallowest focalzones. Tissue models and equipment survey TissuemodelsarenecessarytoestimateattenuationandacousticexposurelevelsIn Situfrom measurementsofacousticoutputmadeinwater.Currently,availablemodelsmaybelimitedin theiraccuracybecauseofvaryingtissuepathsduringdiagnosticultrasoundexposuresand uncertaintiesintheacousticpropertiesofsofttissues.Nosingletissuemodelisadequatefor predictingexposuresinallsituationsfrommeasurementsmadeinwater,andcontinued improvementandverificationofthesemodelsisnecessaryformakingexposureassessments forspecificexamtypes. Ahomogeneoustissuemodelwithattenuationcoefficientof0.3 dB/cm MHzthroughoutthe beampathiscommonlyusedwhenestimatingexposurelevels.Themodelisconservativein thatitoverestimatestheIn Situacousticexposurewhenthepathbetweenthetransducerand siteofinterestiscomposedentirelyofsofttissue.Whenthepathcontainssignificantamounts offluid,asinmanyfirstandsecondtrimesterpregnanciesscannedtransabdominally,this modelmayunderestimatetheIn Situacousticexposure.Theamountofunderestimation dependsuponeachspecificsituation. Fixedpathtissuemodels,inwhichsofttissuethicknessisheldconstant,sometimesareusedto estimateIn Situacousticexposureswhenthebeampathislongerthan3 cmandconsistslargely offluid.Whenthismodelisusedtoestimatemaximumexposuretothefetusduring transabdominalscans,avalueof1 dB/cm MHzmaybeusedduringalltrimesters. Existingtissuemodelsthatarebasedonlinearpropagationmayunderestimateacoustic exposureswhensignificantsaturationduetononlineardistortionofbeamsinwaterispresent duringtheoutputmeasurement. Themaximumacousticoutputlevelsofdiagnosticultrasounddevicesextendoverabroad rangeofvalues:

Asurveyof1990equipmentmodelsyieldedMIvaluesbetween0.1 and1.0attheirhighest outputsettings.MaximumMIvaluesofapproximately2.0areknowntooccurforcurrently availableequipment.MaximumMIvaluesaresimilarforrealtime2DandM Modeimaging. 70 Computedestimatesofupperlimitstotemperatureelevationsduringtransabdominalscans wereobtainedinasurveyof1988and1990pulsedDopplerequipment.Thevastmajorityof modelsyieldedupperlimitslessthan1and4C(1.8and7.2F)forexposuresof firsttrimesterfetaltissueandsecondtrimesterfetalbone,respectively.Thelargestvalues obtainedwereapproximately1.5C(2.7F)forfirsttrimesterfetaltissueand7C(12.6F)for secondtrimesterfetalbone.Estimatedmaximumtemperatureelevationsgivenherearefor afixedpathtissuemodelandarefordeviceshavingISPTAvaluesgreaterthan500 mW/

cm2.Thetemperatureelevationsforfetalboneandtissuewerecomputedbasedon calculationproceduresgiveninSections4.3.2.14.3.2.6inBioeffectsandSafetyofDiagnostic Ultrasound(AIUM,1993). S a f e t y Acoustic output tables Table 8throughTable 13indicatetheacousticoutputforthesystemandtransducer combinationswithathermalindexormechanicalindexequaltoorgreaterthanone.These tablesareorganizedbytransducermodelandimagingmode.Foradefinitionoftermsusedin thetables,seeTermsusedintheacousticoutputtablesonpage 78. Chapter 6: Safety 71 Table 8: Transducer Model: C11x/8-5 Operating Mode: CPD/Color M.I.

(a)

Scan

(a)

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s Control 1: Mode n o i t i d n o C Control 2: Exam Type Control 3: PRF Control 4: Optimization/Depth Control 5: Color Box Position/ Size TIC 1.2 40.50 4.38 0.36 0.5 1.56 2.5 CPD Vas 2841 Med/2.0 Top/

Short

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 72 Table 9: Transducer Model: C60x/5-2 Operating Mode: 2D Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt c i t s u o c A d e t a i c o s s A r e t e m a r a P PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax s Control 1: Exam Type n o i t i d n o C Control 2: Optimization Control 3: Depth Control 4: THI n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C S a f e t y TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

Scan

(a)

M.I. 1.0 1.59 5.3 2.86

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 0.579

(Hz) 7923

(MPa) 2.679

(cm) FLx (cm) FLy (cm)

(W/cm2) 197.7 Any Pen 6.6 cm On

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 73 Table 10: Transducer Model: HFL38x/13-6 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) IPA.3@MImax Control 1: Mode Control 2: Exam Type Control 3: Optimization/Depth/PRF Control 4: Color Box Position/Size c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C TIS Non-scan Aaprt1 Aaprt>1 TIB Non-

scan TIC

(b)

M.I. 1.1 2.556 1.2 5.328 0.525 2597 3.187 325.5 Color Any Low/3.3 cm/

393 Any Scan 1.0 53.49 5.324 0.44 0.4 1.32 2.5 Color Any Med/

2.7 cm/

1938 Top/

Short

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 74 Table 11: Transducer Model: L38x/10-5 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec)

(Hz)

(MPa)

(cm) FLx (cm) FLy (cm)

(W/cm2) IPA.3@MImax Control 1: Mode Control 2: Exam Type Control 3: PRF Control 4: Optimization/Depth Control 5: Color Box Position/Size c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C S a f e t y TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

M.I. 1.3 2.89 1.1 4.91 0.529 9547 3.48 439.3 Color Any 331 Scan 1.0 64.88 4.91 0.54 0.4 1.5 2.5 CPD Bre 2137 Any/3.1 Med/3.1 Any Def/

Def/Def

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 75 Table 12: Transducer Model: P21x/5-1 Operating Mode: 2D Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: THI c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C M.I. 1.3 1.83 5.1 1.84

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 0.963

(Hz) 4421

(MPa) 2.574

(cm) FLx (cm) FLy (cm)

(W/cm2) 209.0 Scan 1.1 122.87 1.88 0.590 1.3 1.55 5.5 TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

Card Abd/OB Pen/

Gen 4.7/7.6 Any cm On 4.7 On

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. 76 Table 13: Transducer Model: P21x/5-1 Operating Mode: CPD/Color Index Label Global Maximum Index Value pr.3 W0 min of [W.3(z1),ITA.3(z1)]

z1 zbp zsp deq(zsp) fc Dim of Aaprt PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Mode Control 2: Exam Type c i t s u o c A d e t a i c o s s A r e t e m a r a P n o i t a m r o f n I r e h t O g n i t a r e p O l o r t n o C s n o i t i d n o C M.I. 1.5 2.19 4.5 2.15

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz) X (cm) Y (cm)

(sec) 1.20

(Hz) 1063

(MPa) 2.574

(cm) FLx (cm) FLy (cm)

(W/cm2) 330.4 Color Abd/

OB S a f e t y TIS Non-scan Aaprt1 Aaprt>1 TIB Non-scan TIC

(b)

Scan 1.3 136.91 2.16 0.918 1.3 3.68 5.5 CPD OB Control 3: PRF/Depth Control 4: Color Optimization Control 5: THI Control 6: Color Box Size 300/10 850/7.5 Any On Any Med Off Short and Narrow

(a) This index is not required for this operating mode; value is <1.

(b) This transducer is not intended for transcranial or neonatal cephalic uses.

#No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) Data are not applicable for this transducer/mode. Chapter 6: Safety 77 Terms used in the acoustic output tables Table 14: Acoustic Output Terms and Definitions Term ISPTA.3 TI type TI value MI Definition Derated spatial peak, temporal average intensity in units of milliwatts/cm2. Applicable thermal index for the transducer, imaging mode, and exam type. Thermal index value for the transducer, imaging mode, and exam type. Mechanical index. Ipa.3@MImax Derated pulse average intensity at the maximum MI in units of W/cm2. TIS TIB TIC Aaprt Pr.3 Wo

(Soft tissue thermal index) is a thermal index related to soft tissues. TIS scan is the soft tissue thermal index in an auto-scanning mode. TIS non-scan is the soft tissue thermal index in the non-autoscanning mode.

(Bone thermal index) is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIB non-scan is the bone thermal index in the non-autoscanning mode.

(Cranial bone thermal index) is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body. Area of the active aperture measured in cm2. Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI (Megapascals). Ultrasonic power, except for TISscan, in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts. W.3(z1) ISPTA.3(z1) Derated ultrasonic power at axial distance z1 in units of milliwatts. Derated spatial-peak temporal-average intensity at axial distance z1

(milliwatts per square centimeter). z1 zbp zsp Axial distance corresponding to the location of maximum [min(W.3(z), ITA.3(z) x 1 cm2)], where z > zbp in centimeters. 1.69

Aaprt

) in centimeters. For MI, the axial distance at which pr.3 is measured. For TIB, the axial distance at which TIB is a global maximum (for example, zsp = zb.3) in centimeters. 78 Table 14: Acoustic Output Terms and Definitions (Continued) Term deq(z) Definition Equivalent beam diameter as a function of axial distance z, and is equal to S a f e t y

4 (

) Wo

ITA z( )

, where ITA(z) is the temporal-average intensity as a function of z in centimeters. fc Center frequency in MHz. Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in centimeters. PD PRF pr@PIImax deq@PIImax FL Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of MI. Pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI in Hertz. Peak rarefactional pressure at the point where the free-field, spatial-peak pulse intensity integral is a maximum in Megapascals. Equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity integral is a maximum in centimeters. Focal length, or azimuthal (x) and elevational (y) lengths, if different measured in centimeters. Acoustic measurement precision and uncertainty Alltableentrieshavebeenobtainedatthesameoperatingconditionsthatgiverisetothe maximumindexvalueinthefirstcolumnofthetable.Measurementprecisionanduncertainty forpower,pressure,intensity,andotherquantitiesthatareusedtoderivethevaluesinthe acousticoutputtableareshowninthetablebelow.InaccordancewithSection 6.4oftheOutput DisplayStandard,thefollowingmeasurementprecisionanduncertaintyvaluesare determinedbymakingrepeatmeasurementsandstatingthestandarddeviationasa percentage. Table 15: Acoustic Measurement Precision and Uncertainty Quantity Precision

(% of standard deviation) Uncertainty

(95% confidence) Pr Pr.3 Wo fc 1.9%

1.9%

3.4%

0.1%

+11.2%

+12.2%

+10%

+4.7%

Chapter 6: Safety 79 Table 15: Acoustic Measurement Precision and Uncertainty (Continued) Quantity Precision

(% of standard deviation) PII PII.3 3.2%

3.2%

Uncertainty

(95% confidence)

+12.5 to -16.8%

+13.47 to -17.5%

Labeling symbols Thefollowingsymbolsareusedontheproducts,packaging,andcontainers. Table 16: Labeling Symbols Symbol Definition Alternating Current (AC) Class 1 device indicating manufacturers declaration of conformance with Annex VII of 93/42/EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features, or to a Class IIa, IIb, or III device requiring verification or auditing by the Notified Body to applicable Annex(es) of 93/42/EEC Attention, see the user guide Device complies with relevant Australian regulations for electronic devices. LOT Batch code, date code, or lot code type of control number Biological risk Device complies with relevant Brazilian regulations for electro-medical devices. Canadian Standards Association. The C and US indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI/UL Standards, for use in Canada and the US, respectively. 80 Table 16: Labeling Symbols (Continued) Symbol REF Definition Catalog number Collect separately from other household waste (see European Commission Directive 93/86/EEC). Refer to local regulations for disposal. STERILE EO Contents sterilized using ethylene oxide process. S a f e t y Corrugated recycle Dangerous voltage Date of manufacture Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high. Do not stack over 10 high. Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices. Chapter 6: Safety 81 Table 16: Labeling Symbols (Continued) Symbol Definition Fragile GEL STERILE R Gel sterilized by radiation. Hot Indoor use only Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle SN Serial number type of control number Storage temperature conditions Submersible. Protected against the effects of temporary immersion. Water-Tight Equipment. Protected against the effects of extended immersion. Handle transducer with care. Type BF patient applied part

(B = body, F = floating applied part) Underwriters Laboratories labeling 82 Table 16: Labeling Symbols (Continued) Symbol Definition Pollution Control Logo. (Applies to all parts/products listed in the China RoHS disclosure table. May not appear on the exterior of some parts/products because of space limitations.) S a f e t y China Compulsory Certificate mark (CCC Mark). A compulsory safety mark for compliance to Chinese national standards for many products sold in the Peoples Republic of China. Contains mercury. (Applies to the LCD and may apply to other components in the ultrasound system.) WARNING: Connect Only Accessories and Peripherals Recommended by SonoSite WARNING:

Connect Only Accessories and Peripherals Recommended by SonoSite Chapter 6: Safety 83 84 Chapter 7: Specifications Thischaptercontainssystemandaccessoryspecificationsandstandards.The specificationsforrecommendedperipheralsareinthemanufacturersinstructions. Supported transducers C11x/85MHz(6ft/1.8m) C60x/52MHz(5.5ft/1.7m) HFL38x/136MHz(5.6ft/1.7m) ICTx/85MHz(5.5ft/1.7m)/

L25x/136MHz(7.5ft/2.3m) L38x/105MHz(5.5ft/1.7m) P21x/51MHz(6ft/1.8m) S p e c i f i c a t i o n s Imaging modes 2D(256grayshades) ColorpowerDoppler(CPD)(256 colors) ColorDoppler(Color)(256colors) Images and clips storage Internalstorage:Thenumberofimagesandclipsyoucansavedependsonimagingmode andfileformat. Accessories Thefollowingitemsareeitherincludedwithoravailableforuseontheultrasoundsystem. Battery BiopsyGuide NeedleGuide Powersupply SystemACpowercord(10ft/3.1m) SSeriesstand Chapter 7: Specifications 85 Peripherals Peripheralsincludemedicalgrade(conformingtoEN606011requirements)and nonmedicalgrade(commercial)products.Manufacturersinstructionsaccompanyeach peripheral. Medical grade Black-and-white printer Recommended sources for printer paper: Contact Sony at 800-686-7669 or www.sony.com/professional to order supplies or to find the local distributor. DVD recorder Non-medical grade Kensington Security Cable USB keyboard Temperature and humidity limits Note: Thetemperature,pressure,andhumiditylimitsapplyonlytotheultrasoundsystem, transducers,andbattery. Table 1: Operating Limits System Battery Transducer 1040C (50104F), 1595% R.H. 700 to 1060hPa (0.7 to 1.05 ATM) 1040C (50104F), 1595% R.H. 700 to 1060hPa (0.7 to 1.05 ATM) Table 2: Shipping and Storage Limits 1040C (50104F), 1595% R.H. System without Battery Battery Transducer

-3565C (-31149F), 1595% R.H. 500 to 1060hPa (0.5 to 1.05 ATM)

-2060C (-4140F), 1595% R.H.*

500 to 1060hPa (0.5 to 1.05 ATM)

-3565C (-31149F), 1595% R.H.

* For storage longer than 30 days, store at or below room temperature. 86 Electrical PowerSupplyInput PowerSupplyOutput#1 PowerSupplyOutput#2 100240VAC,50/60Hz,2.0AMax@100VAC 15VDC,5.0AMax 12VDC,2.3AMax Battery Thebatterycomprisessixlithiumioncellspluselectronics,atemperaturesensor,and batterycontacts. Runtimeisuptotwo hours,dependingonimagingmodeanddisplaybrightness. S p e c i f i c a t i o n s Electromechanical safety standards EN606011:1997,EuropeanNorm,MedicalElectricalEquipmentPart 1.General RequirementsforSafety. EN6060111:2001,EuropeanNorm,MedicalElectricalEquipmentPart1.General RequirementsforSafetySection11.CollateralStandard.SafetyRequirementsforMedical ElectricalSystems. EN60601237:2001+AmendmentA1:2005,EuropeanNorm,Particularrequirementsfor thesafetyofultrasonicmedicaldiagnosticandmonitoringequipment. CAN/CSAC22.2,No.601.1M90,CanadianStandardsAssociation,MedicalElectrical EquipmentPart1.GeneralRequirementsforSafety(includingCSA601.1Supplement 1:1994andCSA601.1Amendment2:1998). CEI/IEC61157:1992,InternationalElectrotechnicalCommission,Requirementsforthe DeclarationoftheAcousticOutputofMedicalDiagnosticUltrasonicEquipment. UL606011(1stEdition),UnderwritersLaboratories,MedicalElectricalEquipmentPart 1:

GeneralRequirementsforSafety. EMC standards classification EN6060112:2001,EuropeanNorm,MedicalElectricalEquipment.GeneralRequirements forSafetyCollateralStandard.ElectromagneticCompatibility.RequirementsandTests. CISPR11:2004,InternationalElectrotechnicalCommission,InternationalSpecial CommitteeonRadioInterference.Industrial,Scientific,andMedical(ISM) RadioFrequencyEquipmentElectromagneticDisturbanceCharacteristicsLimitsand MethodsofMeasurement. Chapter 7: Specifications 87 TheClassificationfortheultrasoundsystem,stand,accessories,andperipheralswhen configuredtogetheris:Group1,ClassA. Airborne equipment standards RTCA/DO160E:2004,RadioTechnicalCommissionforAeronautics,Environmental ConditionsandTestProceduresforAirborneEquipment,Section 21.0EmissionofRadio FrequencyEnergy,Category B. HIPAA standard TheHealthInsuranceandPortabilityandAccountabilityAct,Pub.L.No.104191(1996). 45CFR160,GeneralAdministrativeRequirements. 45CFR164,SecurityandPrivacy. 88 Glossary Terms Forultrasoundtermsnotincludedinthisglossary,refertoRecommendedUltrasound Terminology,SecondEdition,publishedin1997bytheAmericanInstituteofUltrasoundin Medicine(AIUM). as low as reasonably achievable (ALARA) The guiding principle of ultrasound use, which states that you should keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results. curved array transducer depth in situ LCD linear array transducer Identified by the letter C (curved or curvilinear) and a number (60). The number corresponds to the radius of curvature of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, C15, C60e. Refers to the depth of the display. A constant speed of sound of 1538.5 meters/second is assumed in the calculation of echo position in the image. In the natural or original position. liquid crystal display Identified by the letter L (linear) and a number (38). The number corresponds to the radius of width of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, L38. l G o s s a r y mechanical index

(MI) An indication of the likelihood of mechanical bioeffects occurring: the higher the MI, the greater the likelihood of mechanical bioeffects. See Chapter 6, Safety, for a more complete description of MI. MI/TI NTSC PAL See mechanical index (MI) and thermal index (TI). National Television Standards Committee. A video format setting. See also PAL. Phase Alternating Line. A video format setting. See also NTSC. phased array A transducer designed primarily for cardiac scanning. Forms a sector image by electronically steering the beam direction and focus. Glossary 89 skinline SonoHD imaging technology SonoMB technology thermal index (TI) A depth on the display that corresponds to the skin/transducer interface. A subset of the 2D imaging mode in which the 2D image is enhanced by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image. A subset of the 2D imaging mode in which the 2D image is enhanced by looking at a target from three angles and then merging or averaging the scanned data together to improve overall image quality and, in parallel, reducing noise and artifacts. The ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1C under defined assumptions. See Chapter 6, Safety, for a more complete description of TI. TIB (bone thermal index) A thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIC (cranial bone thermal index) TIS (soft tissue thermal index) Tissue Harmonic Imaging transducer A thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body. A thermal index related to soft tissues. Transmits at one frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution. A device that transforms one form of energy into another form of energy. Ultrasound transducers contain piezoelectric elements, which when excited electrically, emit acoustic energy. When the acoustic energy is transmitted into the body, it travels until it encounters an interface, or change in tissue properties. At the interface, an echo is formed that returns to the transducer, where this acoustic energy is transformed into electrical energy, processed, and displayed as anatomical information. 90 Abbreviations Abbreviations in User Interface Abbreviation Abd Bre CPD Crd MB MI Msk Nrv NTSC OB S SmP THI TI Vas Ven Definition Abdomen Breast Color Power Doppler Cardiac SonoMB Mechanical Index Musculoskeletal Nerve National Television Standards Committee Obstetrical SonoHD imaging technology Small Parts Tissue Harmonic Imaging Thermal Index Vascular Venous l G o s s a r y Glossary 91 92 Index Numerics 2D imaging 21 A abbreviations 91 abdominal, intended uses 11 accessories list 85 acoustic measurement precision 79 acoustic output measurement 69 tables 71 terms in tables 78 acquisition error 36 add new user 15 Administrator 14 airborne equipment standards 88 ALARA principle 62, 63, 89 alphanumeric keys 7 audio 3, 18 B battery charge 3 clean 43 install or remove 3 safety 56 setup 18 specifications 87 biological safety 57 Biopsy 24 brightness 21 C cables, connect power 4 calipers 33 cardiac, intended uses 11 cautions, definition vii cine buffer 23 clean battery 43 LCD screen 40 system 40 transducers 41 click 9 clips length 19 See also images and clips color Doppler (Color) imaging 22 color power Doppler (CPD) imaging 22 Color. See color Doppler (Color) imaging connectivity setup 18 symbols 3 control keys 8, 9 controls direct 63 indirect 64 receiver 64 CPD. See color power Doppler (CPD) imaging customer assistance vii D date 19 default settings 13 depth adjust 23 definition 89 marker 8, 19 disinfect battery 43 system 40 transducers 41 disinfectants, compatibility 44 display brightness 19 distance measurements 34 DVD recorder 18, 37 E electrical safety 53 specifications 87 electromagnetic compatibility 58 electromechanical safety standards 87 Ellipse 35 EMC classification standards 87 equipment safety 56 error message 55 Index 93 I n d e x errors acquisition 36 algorithmic 36 measurement 36 Event log 16 exam end 27 type and transducer 25 type, change 24 export Event log 16 images and clips 31 USB Devices setup 20 user accounts 16 F focal zones, optimize 22 freeze 23 G gain adjust 23 Auto Gain 21 grace period 38 guidance documents, related 67 Guide 24 guidelines 24 gynecology, intended uses 11 H HIPAA standard 88 humidity limits 86 I image quality, poor 37 images and clips delete 31 export to USB 31 review 30 save 28 imaging modes list of 85 transducer 25 import user accounts 16 in situ, definition 89 infertility, intended uses 11 intended uses 11 intensity derated 69 in situ 69 water-value 69 interventional, intended uses 11 K keyboard, on-line 9 keys 7 knobs 7 L labeling symbols 80 language 19 LCD screen clean 40 output 67 license key 38 login Administrator 14 user 14 M maintenance 39 measurements accuracy 33, 35 area, 2D 35 circumference, 2D 35 delete 34 distance 34 edit 34 errors 36 mechanical index (MI) 67, 89 mode data 8, 19 N needle guide 24 NTSC definition 89 option 18 O OB, intended uses 12 optimize 22 94 Index orientation marker 8 option 22 output display 67 P PAL definition 89 option 18 password 15, 16, 17 patient header 8, 19 patient information form 27 patient list 28 PC 18 pediatric, intended uses 12 peripherals 86 power delay 18 power key 7 precision, acoustic measurement 79 preferences 19 presets 19 pressure limits 86 print 30 print control 3 printer problem 37 setup 18 probe. See transducer R recording problem 37 S safety battery 56 clinical 57 electrical 53 electromagnetic compatibility 58 equipment 56 save 28 scanhead. See transducer screen layout 8 security 14 serial port 18 setup pages 13 shipping specifications 86 skin line, definition 90 sleep delay 18 software license 38 SonoHD 90 SonoMB 22, 90 specifications 85 standards airborne equipment 88 electromechanical 87 EMC classification 87 HIPAA 88 storage specifications equipment 86 images 85 superficial, intended uses 12 symbols connectivity 3 labeling 80 system clean and disinfect 40 controls 7 software 1 status 8 wake up 4 T Technical Support viii temperature limits 86 text, enter 9 thermal index (TI) 19, 67, 90 time setup 19 tissue models 70 touchpad 9 transducer clean and disinfect 41 connect 5 curved array 89 definition 90 disinfect 41 exam type 25 general use 10 imaging modes 25 invasive or surgical use 10 linear array 89 preparation 10 problems 37 sheath 10 specifications 85 troubleshoot 37 I n d e x Index 95 U ultrasound terminology 89 USB export 20, 31 insert or remove device 6 port 3 user accounts 16 user guide, conventions used vii user setup 15 uses, intended 11 V vascular, intended uses 12 video 3 W warnings, definition vii Z zoom 24 96 Index P07525-01

*P07525-01*

 

 

B1U~U)C)lh . L'SB Adapter Connect your peripherals and computing devices without cables BU-2080J/ BU-2063-J / BU-2073 BU-208lJ I BU-2061-J / BU-2071 BU-2090J BU-209lJ Quick Installation Guide computer, CPU speed of200MHz or above Introduction PC System Requirements

. PC-compatible

. Memory: 64MB or above, 128MB recommended

. One available USB port, USB 1.1 standard

. Windows@ 98SE,Me,2000,andXP Product Contents

. Bluetooth USB Adapter

. CD-ROM for installation software and documentation

. Quick Installation Guide Step 1:SoftwareSetup Software Setup for Windows 98 SE, Me, 2000, and XP To install the software for the USB Adapter, follow the instructions below:

Note: The installation process for Windows XP may look slighdy different from Windows 98 SE, Me, and 2()(X). Note: Do not insert the USE Adapter into the USE port prior to software installation. 1. Insertthesoftwareinstallation CD-ROM intothePC sCD-ROMdrive. 2. The "SoftwareInstallShieldWizard"

windowappears.Clickon "Next"

begintheinstallationprocess. to Welcome to the InstallShield Wizard for WIDCOMMBluetoothSoftware3.0.1.BOO The InstaIlShield(R) Wizard will install WIDCOMM Bluetooth Software on your computer,To continue,clickNext, WARNING: ThiS program is,protected by copyright international treaties, law and 2 1:

3. Choose"racceptthetenns in the licenseagreement licenseagreement.Click on to continue. to acceptthe

"Next"

Pleaseread the followinglicenseagreementcarefully, INC. TO THE WIDCOMM SOFTWARE ACCOMPANYING

("WIDCOMM") IS WILLING LICENSE AGREEMENT I DCOJvIM, LICENSE THIS YOU ONLY ON THE CONDITION OF THE TERMS IN THIS THE TERMS CAREFULLY. ACCEPT BUTTON YOU ACKNOWLEDGE THI S AGREEMENT,

THE TERMS OF THIS

00

(THE

"SOFTWARE") TO THAT YOU ACCEPT ALL AGREEMENT. BY CLICKING LICENSE PLEASE READ ON THE

"I AGREEMENT"

THAT YOU HAVE READ UNDERS,TAND IT AND AGREE

TO BE

Cancel

@ ~i~~~~~I6:~:~~im~::!~Ih~~!!~~6:~~:~~f~~:~~:~~l 0 r'go not accept the terms in the license agreement'. 4. Specify the location where the software files will be installed on your hard drive. It is recommended that you install the software in the default directory Bluetooth Software\"

to continue. Click on

"C:\Program Files\WIDCOMM\

"Next"

ClickNext to installto.this folder, or clickChange to installto a different folder.

3 5. Confmn that the device software

-is readyto be installedandclick on "Install" . The wizard is ready to begin installation. 6. The InstallShield Wizard will begin to install the Bluetooth Software. This may take several minutes. The program features you selected are being installed. DC:OMM Bluetooth 4 1:

7. During the installation process you may be prompted to insert your USB Adapter. If your USB Adapter is not plugged into your computer at this time, you may insert

"OK"

it into an available USB 1. I-compliant then click Bluetooth device inserted. Refer to the Manual for instructions for installing the hardware. to continue. Click on port on your desktop or notebook computer,

"Cancel"

to continue installation without the

"Hardware Installation"

section of this User Note: If at any time during the installation process you receive a Notice",click

"OK" tocontinuetheinstallationprocess. 5

"Driver Signature 1:

"Finish"

and restart the InstallShield Wizard Completed TheInstallShieldWizardhas successfullyinstalledWIDCOMM BluetoothSoftware. ClickFinishto exit the wizard. 6 1:

Setup Hardware Setup for Windows98 SE, Me, 2000, and XP Follow these instructions to install your USB Adapter on your Pc. Note:YourUSEAdapteris sensitiveto staticelectricity,whichcandamageits delicate electrical components. To protect your device, always touch the metal chassis of your computer before handing the USE Adapter. This will ground any potential electrostatic discharge. A void touching the metal connector when handling the USE Adapter. Dry weatherconditionsor walkingacrosscarpetedfloorsmay causeyou to acquirean electrostaticcharge. 1. Connect the USB Adapter directly to an available USB A-type connector on your desktop or notebook computer. Your system should register a new USB device found. 2. Choose then click

"Install from a list or specific location'

"Next"

Welcome to the Found New Hardware Wizard Thi$wizard.help$

you in$tall $oftware for:

BCM2035B2 If your hardwarecame with an installation CD odloppy disk. insert it now. What do you want the wizard to do?

Imtall the $oftware automatically (Recommended)

@ li.h~.t~ri.Ji.Q.~:.'~':.i.lif'i?'i.'i.P..~.g.iH9".i.Q.g.~.t!'i?'6]~.~.v..~.6.g.~.~1 Click Next to continue. Cancel Step 2: Hardware Setup 7 3. Browse for the location of the device driver"

:\Program Files \WIDCOMM\

Bluetooth\Software\bin\"

click

"Next". then Ph~ase choose your search and installation options. I!J 4. If you receive the following installation notice" ,click on Anyway"

installation process. to continue with the

"Hardware

"Continue 8 2: Hardware Setup 5. A window will appear that confums the completion of the hardware installation;

click on to complete the installation process.

"Finish"

Completing the Found New Hardware Wizard The wizard has finished installing the software for:

0 BroadcomUSB Bluetooth Device Click Finish to close the wizard. Step Hardware Setup 9 Uninstalling the Software for Windows98 SE, Me, 2000, and XP Follow these instructions to uninstall your USB Adapter on your Pc. 1. Insert the CD-ROM included with your USB Adapter. 2. This the CD and run the 3. The uninstall process. 10 should automatically load. If it does not load, explore file.

"InstallShield Wizard"

"Setup.exe"

"InstallShield" window should now appear. Click to continue with the

"Next"

Federal Communication Commission Interference Statement 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 protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used 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 this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:

. Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an eJPerienced radio/TV technician for help. Increase the separation between the equipment and receiver. FCC Caution :To assure continued responsible for compliance compliance, any changes or modifications not expressly approved by the party could void the user's authority to operate this equipment.

(Example

- use only shielded interface cables when cormecting to computer or peripheral devices). FCC Radiation Exposure Statement This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of20 centimeters between the radiator and your body. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. The antennas used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or op erating in conjunction with any other antenna or transmitter. I L