SIEMENS SONOLINE Prima Ultrasound Imaging System Operating Instructions es ce 0123 ‘Siemans Madical Systems, Inc., Ultrasound Group skessestiononevorSONOLINE Prima Ultrasound Imaging System Operating Instructions From Software Version 2.4.0 Siemens Medicai Systems, Inc. Ultrasound Group P.O. Box 7002 22010 S.E. 51st Street Issaquah, WA 98029-7002 (425) 3£2-9160 Operating instructions Reorder Number: 44 85 868-H300 ©1996, 1997 Siemens Medical Systems, Inc. All Righ:s Reserved, 08.97 Printed in the Federal Republic of Germany. ‘SONOLINE is a registered trademark af Siemiens Medical Systems, Inc. LITHOSTAR is a registered trademark of Siemens Medical Systems, Inc. CIDEX isa trademark of Jonnsan and Johnson, ine. CIV-FLEXis 6 trademark of CIVCO Medical Instruments, Ca., Inc. SONOLINE* Prima imaging systems with 230 volt power suppties are CE certified. Siemens reserves the right to change system specifications at any time. i Wm sometime Pama OPERATING INSTRUCTIONS raatocsnE¥00About this Manual The purpose of this user's manual is to provide operating instructions for the SONOLINE® Prima diagnostic utrasound imaping system. instructions are inclued for caring fot, meintaining, cleaning, disinfecting, and using the Prima imaging system. For the purposes of this manual, the use of the term Prima wil refer to the SONOLINE rims imaging system. Conventions used throughout this manual are listed below. Teke # moment to familiarize yourself with these conventions. Warnings, Cautions, and Notes WARNINGS: Warnings are intended to aien you to the importance of following the correct operating procedures where risk of injury to the patient or system user exists CAUTIONS: Cautions are intended to alert you to the importance of folowing correct operating procedures to prevent the tisk of demage to the system. NOTE: Notes contain information concerning the proper use of the system and/or ‘correct execution of a procedure, Purpose Conventions 2s es.oas von SONOLIE PRIMA OSERATING INSTRUCTIONS miMConventions System Controls Keys and controls located on the control panel are identified by uppercase, boldface type. Example: Rotate the DEPTH control Function keys located on the keyboard are identified by the number of the function key followed by the name in boldface type. Example: Press the Fa Preset Menu function key. Menu selections are identified by the name of the selection in beldface type. Example: Roll the trackball to highlight Offset in the System Status Menu, Special Terms and Preset Options Special ts1ms are indicated in italics and are accompanied by a brief description oo their first use in the manual. Example: Provides on-screen anatomical graphics or pictograms that indicate the anatomy under evaluation. Options in the General System Set Up menus can be identified in text as boldtace type. Example: Highlight the Keyboard - Annotation option. Wm SOKOLINE PRIMA OPERATING INSTRUCTIONS sree aca nso neveTable of Contents ‘SONOLINE Prima Diagnostic Ultrasound Imaging System Operating Instructions Ghapter Tite Chapter Description Chanter 1 General overview of the SONOLINE Prima diagnostic Introduction, Safety, and Care Chapter 2 System Controls Chapter 3 System Set Up Chapter 4 Getting Started Chapter 5 Imaging Functions Chapter 6 General System Set Up Menus ‘Chapter 7 Calculations and Measurements Chapter 8 Documentation and Storage Devices ‘8 wos 600 ultrasound imaging system, including system options, Yeatures, and design. Detailed information on system safety ‘and how to care for and maintsin the system and accessories, Explanation of all controls and keys on the control panel, including the alphanumeric keyboard. Detailed descriptions of how to transport, set up, and prepare the system for use. Information on starting an examination, including instructions: ‘or entering and editing patient data, and selecting an exam ‘ype, imaging mode, and transducer. Procedures explaining how to activate an imaging mede, including descriptions of the imaging functions for B-mode and ‘M-mode imaging Instructions for using the options and selections in the General ‘System Set Up menus to customize the system. Examples of the General System Set Up menu and its associated submenus are provided with a detailed description of each ‘menu item and option. Step-by-step procedures for using the Measurement function. ‘The procedures that apply to all exam types, including the report feature, are described first. The remainder of the chapter details the measurements and features specific to each exam type. Information on how to use the Prima system with documentation and storage devices, including @ complete description of the 3.5:inch floppy disk drive.Chapter Tite (Chapter Description Chapter 9 CINE Review Chapter 10 ECG Function Chapter 11 Transducer Accessories Chapter 12 Endocavity Transducers Chapter 13 Specialty Transducers Chapter 14 Enhanced OB Package Appendix A Technical Data Appendix B Transducer Technical Data and Acoustic Intensities Appendix C List of Distributors. Appendix D List of Part Numbers ‘Appendix E Obstetric References Appendix F Data Transmission Guidelines index Mio uum SONOLINE PRIMA OPERATING INSTRUCTIONS Information on how to review CINE data, either frame by frame or as a loop, and how to edit the Icop of data. Explanation of the ECG option, including procedures for ‘specific functions on the Prima system. Attachment procedures for transducer accessories, including 0 needle path verification procedure. ‘A description of the endocavity transducers and accessories and their use with the Prima system. A description of the intraoperative transducers and their use with the Prima system, Explanation of the features and caculations contained in the ‘optional Enhanced OB package. Technical description of the Prima imaging system Acoustic power intensities and MUTI information. Listing of names and addresses of authorized distributors for the Prima imaging system. Listing of part numbers for the available configurations of the Prima imaging system, including accessones and options Listing of authors and reference tables used in the Prima imaging system for the Obstetric exam, Guidelines for transmitting date from the Prima imaging system through the RS-232C port to a PC of laser printer. Index. steeaseimanneveoSONOLINE PRIMA OPERATING INSTRUCTIONS Will Chapter 1 introduction, Safety, and Care Oe Contents Introducing the SONOLINE Prime Diagnostic Utrasound Imaging System. Intended Use. System Features... ‘System Options TRAMSAUCERS sana Transducer Accessories so Documentation and Storage Devices. Imaging Ser@@n coe Screen Saver. maging Menus... System Status Menu Measurements Menu Disk Menu. Biopsy Menu .. Imaging Modes . Calculations and Measurements. : Enhanced Obstetrics Package... Presets and Customization ‘Quick Sets... System Symbols. Biohazard Considerations... Transmit Power Level. Power Control. Transmit Powar Dispiy . Mechanical and Thermal INdiCES....crnrnnes Imaging Functions that Change Acoustic Output essenuenonve BONCLINE PRIMA OPERATING INSTRUCTIONS Bin 1-1CHAPTER 1 Intraduction, Se ElectricaVEnvironmental Safety Requirements... Power Supply. Enviranmental Spectications. Use of Peripheral Devices....... Equipment Care. so Caring for the Prima Imaging System... Daily Checklist. Maintenance Siemens Authorized Care..... Caring for Transducers... Protective Case Storage.. 7 . Cering for Trenstucer Accessories ‘Transducer Covers Waterpath Standoff Kits, Needle Guide Bracket Kits ...nse: Caring for Documentation and Storage Devices. - Cleaning ang Disinfecting... . Cleaning ang Oisinfecting the Prime Imaging System Cieaning and Disinfecting Transducers. Cleaning, Disinfecting, and Sterilizing Transducer Accessories Waterpath Standott Kits, Needle Guide Bracket Kits... 1-2 num SONGLINE PRIMA CRERATING IuSTAUCTIONS amas meccaCHAPTER 1 Introduction, Safety, and C Introduction This chapter provides 2 general overview of the SONOLINE Prima imaging system, including tts intended use, system features, and system options. The imaging screen ‘and imaging modes are described, and the menus used during imaging are briefly ‘explained. The overview also provides @ descriotion of compatible transducers and ‘related documentation devices. There are severe! important precautions you must follow to operate the Prima imaging systom safely and correctly. The Biohezérd Considerations section describes transmit levals and how to minimize patient exposure to ultrasound. The Care and Meintenance ‘section describes how to care for, clean, and disinfect the imaging system and its comaonents, =n Introducing the SONOLINE Prima Diagnostic Ultrasound Imaging System ‘The SONOLINE® Prima diagnostic ultrasound imaging system provides complete clinical images in a variety of real-time imaging modes. The Prime imaging system allows you to perform a wide range of diagnostic ultrasound ‘examinations, including those for obstetrics, gynecology, and uroiogy, with a standard caiculations and measurements softwere package provided. The Prima imaging system can be configured to support your diagnostic requirements. ‘The Prima imaging system is compact and self-contained, end cen be maneuvered into exam sitas where floor space is timited. The imaging system ‘can navigatz doorways, elevators, mobile van doors, and small examination rooms such as these in clnies, in doctor's offices, and in emergency rooms. The imaging system can aiso be transported long distances with oniy a limited ‘amount of disassembly, ‘Tha Prima imaging system is compatible with a variety of linear end curved array ‘and mechanical sector transducers. The configuration of an individual imaging system defines the transducer types available on that particular system. The 'SONOLINE Prima ultrascurd imaging system is available in three basic ‘configurations in either the 115V or the 230V version * SONOLINE Prima SLC Sector, linear array and curved array system with one sector port and, ‘wo linear of curved array ports. + SONOLINE Prima LC Linear and curved array system with two linear or curved array ports. * SONOLINE Prima S Mechanical sector {fixed focus) system with two sector ports. scosesuocoreven SONOLINE PRIMA GPERATING INSTRUCTIONS win 1-3CHAPTER 1 Introguetion, Safety, and Care All of the transducers are activated from the control panel. The layout of the contro! panel facilitates quick recognition of control locations. The keyboard ‘controls and keys are beckiit, and receive additional task lighting for easy identification in areas with dim fighting, The backlighting increases on @ control key when itis pressed, to indicate that the function is active, (On the 118V version of the Prima imaging system, each control on the control panel is labeled with an icon and English text. On the 230V version, the controls are labeled with icons only. Both versions of the system support menus and teports in English, German, French, and Spanish. ‘Tha Prima imaging system supports a variety of optional documentation devices: Such as a video printer. Some of these devices can be integrated into the system, while others can only be supported externally. Moritor with imaging sereen Cont pane! VOR bay (VCR is ortionat) Transducer and ge! halders Flopay disk crve Transdveer ports ECG and ‘oatewiteh ‘connections Video printer Endocaviry transducer holcer ee SONOLINE Prime utrasound imaging system. F-4 uum SOmOLINE PRIMA OPERATING INSTRUCTIONS exresavereevesCHAPTER 1 Introduction, Safety, and Care Intended Use ‘The Prima imaging system is suitable for a wide range of diagnostic applications, including: General medicine Abdominal applications - adult and pediatric ‘OB/Gyn applications Endo-vaginal applications General urological applications Endorectaliprostate applications ‘Small parts applications Pediatrics Neonatal head imaging Ear, nose, and throat (ENT) applications Orthopedic applications ‘Surgical applications - intracperative Cardiac applications ‘A:table showing the specitic intended application(s) for each transducer can be found in Appendix B. ‘The Prima imaging system can also support veterinary applications. SOWQLINE PRIMA CPERATING INSTRUCTIONS mui 18CHAPTER 1 Introduction, Safety, and Care System Features ‘The SONOLINE Prima S ultrascund imaging system provides the following standard features: 1-6 12-inch (30 em tt-and-swivel gray scale monitor (compatible with multiple video standards) Control panel with keyboard in 118V or 230V version ‘Two mechanical sector transducer pores ‘Mechanical sector transducer compatibility with 3.5- to 10-MHz transducer range 285-cegree R-theta scan converter S-mode, 25-mode, 48-mode, 8+ B-mode, and M-mode imaging with mixed modes for B/MV-mode, 8+B/M-moce, and A-mode display Variable field size with magnification (Read end Write Zoom) 3.54nch floppy disk drive for storing and retrieving user presets, system software, patient images, and repon data Caleulation and measurement software for diagnostic examinations Menu-criven system software for setup and configuiration. Supports ‘multilingual operation in English, German, French and Spanish Built‘in video printer Internal mounting for optional video recorder ‘Video-out for customer-supplied second monitor of externat documentation devices ‘Video-n for playback from an exterai video source, such as a VCR AS-232C (seria) port for measurement and calculation date transmission lnm SONOLING PRIMA OPERATING INSTRUCTIONS eemmacion neCHAPTER 1 Introduction, Salety, and Care ‘The SONOLINE Prima LC uttrasound imaging system provides the following standard features: ‘+ 12ineh (80 emi tilt and swivel gray scale monitor (compatible with multiple video standards} = Control panel with keyboard in 115V or 230V version © Two linear or curved array transducer ports = 82 electronic channel finear and curved erray front end + Linear and curved array transducer capability with 3.5- to 7.5-MH2 wansducer range + Bmade, 2B-mode, 48-mode, B+B-made, and M-mode imaging with mixed modes for B/M-mode, 8+B/M-mode, and Amode display + Veriable field size with magnification (Read ana Write Zoom) + Adjustable single and dua! focusing, and fixed quadruple focusing, with linear or curved ary transducers + 3.5:nch floppy disk drive for storing and retieving user presets, system software, patiant images, and report data + Calculation and measurement software for diagnostic examinations + Menu-driven system software for setup and configuration. Supports ‘multilingual operation in English, German, French and Spanish = Buittin video printer ‘= Intemal mounting for optionai video recorder + Video-out for customer-sunplied second monitor or external documentation devices = Video-in for playback from an external video source, such as a VCR = RS-232C (serial) port for measurement and calculation date transmission senssan norte SONOLINE PRIMA OPERATING INSTRUCTIONS &CHAPTER 1 Introduction. Safety. and Care ‘The SONOLINE Prima SLC ultrasound imaging system provides the Yoliowing standard features: + 12:inch (30 cm) tilt and swivel gray scale monitor (compatible with multiple video standards) + Image screen for the display of clinical images, patient information, operating parameters, end graphic overlays and objects + Control panei with keyboard in 115V or 230V version + One mechanical sector and two linear or curved array transducer ports, "32 electronic channel linear and curved array front end + 358-degree R-theta scan converter + Linear and curved array transducer compatibility with 2 3.5 to 7.5 MHz trenscucer range, ‘| Mechanical sector transducer compatibility with 3.5: to 10-MHz ‘transducer range: + Bode, 28-mode, 43-mode, B+8-mode, and M-mode imaging with mixed modes for B/M-made, B+B/M-mode, and A-made display ‘+ Variabie fisid size with magnification (Read and Write Zoom) + Adjustable single and duel focusing, and fixed quadruple focusing, with linear or curved array transducers + 35-inch floppy disk dive for storing and retrieving user presets, system software, patient images, and report data + Calculation and measurement software for diagnostic examinations +) Menusdriven system software for setup and configuration. Supports multi-Jinguat operation in English, German, French end Spanish * Builtin video printer + Internal mounting for optional video recorder ‘+ Video-out for customer-supplied second monitor or external documentation devices + Video-in for piayback from an external video source, such as @ VCR. + RS-232C (serial) port for measurement and calculation data transmission 1-6 lm SowOLsNE PRIMA CRERATING INSTRUCTIONS eects reveCHAPTER 1 Introduction, Safety. and Care System Options Ail three configurations of the SONOLINE Prima imaging system ean support the following system options: CINE Review (31 frames) Enhanced Obstetrics measurement and reporting software ECG option VCA with internal mounting kit Hard drive (HD) or magneto-optical crive (MO) arive Dual pedal footswitch The SONOLINE Prima also supports report data transfar to an external printer or PC-based data analysis systems. Refer t0 Chapter 7 for information on exam reports and to Chapter 8 for information on documentation devices seemuameve SONOLIME Paima OPERATING INSTRUCTIONS min) T-SCuaPreR + Introduction, Safety, and Care Transducers ‘The Prima imaging system is compatible with a veriety of mechanical sector and [near and curved array transducers, depending on the specific system configuration. ‘The name of each transducer indicates its type and operational characteristics. For example, the 3.5C40S transducer operates at 3.5 MHe, is en S-Array Curved type, and has @ 40-mm radius. ‘Curved SAsray Uneer SAray Mechanical Sector Other 85 CaS 35 L155 358115 75.60.08 intraoperative 350798 5095S, 3.55.01 One) 5.0 CaS 78 788, 5OSI12Z 75 15015 lintrzoperatve esevss 7.5 L458, 507881 tows 5.0/7.5 Micro Sector 7.5 Mecro Sector X Endo Endo-P Il 1-10 unm SONGLINE PRIMA GPERATING INSTRUCTIONSCHAPTER 9 Introduction, Safety, and Care Transducer Accessories Curved S-Array Transducers 3.8. C405 Nestle Guide Bracket Kit, Transcucer Cover 35.0705 Transducer Cover 50Ca0S Neadle Guide Bracker Kit, Waterpath Standoff Kit, Transducer Cover 65 EVISS ‘Transducer Cover, Needle Guide Bracket Kit Linear S-Array Transducers a8 L118S Transducer Cover 6.0 96S Needle Guide Bracket Kir, Waterpath Stando# Kit, Transducer Cover 7.8 LISS Needle Guide Bracket Kit, Waterpath Standoff Kt, ‘Transducer Cover 7.5 LASS Needle Guide Bracket Kis, Waterpath Standoff Kix, Transducer Cover (Mechanical Sector Transducers 358116 Needle Guide Bracket Kit, Waterpath Standoff Kit, Transducer Cover 3.86.05) Needle Guide Bracket Kit, Weterpath Standoff Kit, ‘Transducer Cover 5.08112 Needle Guide Bracket Kit, Weterpath Stendoff Ki, Transducer Cover 5.0778 Si Needle Guide Bracket Kit, Waterpath Standoff Kit, ‘Transducer Cover 5.07.5 Mero Sector ‘Tansducer Cover 7.5 Micro Sector ‘Transducer Cover Endov Needle Guide Bracket Kit, Transcucer Cover Endo? Needle Guide Bracket Kit, Waterpath Balloon, ‘Transducer Cover (Other Transducers 7.8 L60 QS intraoperative Q-ype} Transducer Cover 7.8 L50 IS (intraoperative Htype) Transducer Cover emmmanwre SONOLIME PRIMA OFERATING INSTRUCTIONS mul oeCHAPTER 1 Introduction, Safety, and Care Documentation and Storage Devices ‘The Prima imaging system is equipped with a 3.5inch floppy disk drive as a standard feature. The Prima imaging system can also accommodate optional documentation and storage devices, including: + Video cassette recorder (internal or external mount) + Multi-format cemera texteral) + Report printers (external) ‘The decumentation end storage devices that are connected externally operate as. separate units. These devices are not directly controlled from the Prima imaging system, Refer to the manufacturer's instructions for specific information concerning the operation of these devices. SONOLINE PRIMA CPERATING INSTRUCTIONSChAPTER + Introduction, Safety, anc Care Imaging Screen ‘The Prima imaging system's monitor screen displays clinical images ziong with patient information and operating parameters. The monitor screen can also display graphic overlays, and features such as calipers and pictograms, to assist in evelusting the image. The moritor can be tited or swiveled to optimize the viewing angie or show images to the patient. + 2 1 Patient and IL hospital Information 2 mage area 3 System ‘Status Menu 4 Depth scale distiay 5 Track pointer 6 Mechanical ‘and Thermal ingices 7 raging paremerers {and VCR tape code 8 Tracie Stave fel 8 Gray bar 10 Focal zene Iingiators Certain areas of the imaging screen can be used to perform more than one function. The information that is displayed on the right side of the imaging ‘screen can change as a result of your current activity. This area normally displays the System Status Menu, which provides information about the current imaging mode, unless you: * Initiate @ function that displays another menu, such as the Measurements Menu, in place of the System Status Menu. Certain imaging parameters are still displayed et the bottom left of the screen, unless Generat System Set Up Menu 7 has been used to turn off the System Status Parameters display + Press F1 New Patient, F2 Report, or F3 Pationt Data to display a page ‘of patient information or press Fé Preset Menu to cisplay « General System Set Up menu ‘The different imaging menus are described on page 1-15. The General System Set Up menus are discussed in detail in Chapter 6. seesenermseeves SONOLINE PRIMA CPERATING INSTRUCTIONS Mul 1213CHAPTER 1 Introduction, Safety. and Care Screen Saver NOTE: When image information is being played back from a video input source, such 28 2 VCP, the screen saver function is turned off. See Chapter 10 for mstructions an using @ VCR with the system. ‘The image display screen is covered by a screen saver graphic after a specified period of time. You can use General System Set Up Menu 1 to determine the lengt of time before the screen saver is displayed. Refer to Chapter 6 for specific information. ‘The sereen saver is turned off and the previous cisplay is restored when you ress a key or adjust any of the controls, The function of the key or contro! will ‘not be executed. since itis restoring the image display. After the screen display is restored, the keys anc controis will function as usual. 1-14 sum soworiNe PRIMA OPERATING INSTRUCTIONS.Charten 1 Introduction, Sefery, and Care imaging Menus Imaging menus are displayed along the right side of the sereen while you are using an imaging function. Only one of these menus is active at a time. imaging parameter date is elways displayed at the bottom ‘eft of the imaging screen, unless it has been turned off using General System Set Up Menu 3 System Status Menu ‘The System Status menu indicates the stetus and parameters of the current imaging mode as well as frequency, depth, and transmit power level of the active ‘ransducer. Refer io Chapter 5 for information on imaging mades, and Chapter 6 for information on exam: specific traneducer settings. Measurements Menu ‘The Measurement menu is displayed in the upper right comer of the screen when the CALIPER key on the contro} panel is pressed. Exam- specific parameters are displayed in the upner section of this menu. Measurement methods are listed and cafculation results are displayed in the lower section. Refer to Chapter 6 for detailed information on Calculations and Measurements. k Menu The Disk Menu is displayed in the upper right comer of the screen when the DISK key on the control panel is pressed. This menu provides options for storing and retrieving images using the floppy disk crive. Refer to Chapter B for detailed information. ee ascrs 35 FPS tea Angie 803 Offse: Oy fog 60c8 Persist 7 Eoge i Gan 4038 Cup 3B Gray Map ECG off Examele of the Systom Status Menu. ‘abe B5CRS 85, DISTANCE 2PTELL TRACE POINT VOLUME 1P VOLUME 2P RATIO Example of a Measurements Manu. ‘Aba DISK MENU. Drive Fo Directoy Recall ae Stere image Stere Cine Stere Rep Copy File Delese Fite Delete rng Format Dis Example of the Disk Meru cers veconevan SOMOLING PRIMA OPERATING INSTRUCTIONS mi 1-15CHAPTER + Introduction, Safety, and Care i 3 Biopsy Menu ae FS 186 The Biopsy Menu is displayed in the upper right comer of the screen when Bioosy the BIOPSY key on the control panel is pressed. Parameters relating to the Botsie LAG biopsy can be adjusted using this menu, Refer to Chapter 11 for detailed Swot information| swe 8 Type AL Example of the Biopsy Menu 1.16 jnM@ SONGLINE PRIMA OPERATING INSTRUCTIONS smocerenereCHAPTER 7 Introduction, Safety. and Care Imaging Modes ‘The Prime imaging system provides imaging capability in the following modes for all compatible transducers. Refer to Chapter 5 for snecific information. Bmode 2B-mode B+B-mode 4B-mode B/M-mode 8+B/M-mode A-mode B-mode is the default setting. When you power-on the system, the imaging screen is initially displayed in B-mode. A single active ‘S-mode image is displayed in the image ares. 2B-mode displays two separately acquired 8 mode images, side by side. 2B-mode aliows you to switch from cne B-mode image te the next B+8-made displays two identical B-mode images, side by side. “The two images are simultaneously either real-time or frozen. Each image can show different posi- processing functions. 8+B- mode can also be used with ECG-triggered image acquisition. 4B-mode displays up to four separately acquired B-mode images at the seme time. 4B-mode is useful for comparing number of anatomical views on one screen or film. Only one image ata time can be displayed in reaktime. M-mode displays a full-screen M-mode sweep. M-mode is also called Time Motion Mode. B/M-mede simultaneously dispiays 2 B-mode image with an M-mode sweep. Several display formats are available. B+B/M-mode simultaneously displays a B+B-mode image with an Murode sweep. ‘A-mode displays an amplitude readout in graph form on the left side of the active B-mode or M-mode image. cS 7m mM |-4 BS SONOLINE PRIMA OPERATING INSTRUCTIONS min 1-17CHAPTER 1 Introduetion, Safety, and Care Calculations and Measurements ‘The Prima imaging system is equipped with a calculations and measurements package that is used with 2 wide range of diagnostic ultrasound examinations ‘The exam results are included in the relatad patient examination reports for the OB, Gyn, Urology, Orthopedics, and Cardiac exams. + Standard Obstetricat exam. Supports fetal age and delivery dete ‘estimation for the parameters MSD. CRL, BPD. HC, AC, FL, and four user-definable parameters. User-defined descriptive data ard fetal ‘weight estimation are also supported "Urology exam. Consists of the Prostate and Endorectal exams. Inciudes 2 calculation for determining residual urine volume and supports prostate imaging, a prostate volume measurement, and a PSAD calculation, ‘+ Orthopedic exam. Includes ¢ measurement of the infant hip engle. + Small parts imaging. includes e thyroid volume measurement. + Abdominal, cardiac, end gynecological exers. Patient Reports are avaitable for the OB, Gyn, Prostate, Endarectal, Orthopedics, and Cardiac exams. Refer to Chapter 7 for specific information on each type of exam Enhanced Obstetrics Package ‘An Enhanced Obstetrics package is available as a separate system option. This package provides extensive and detailed reporting capabilities, and adaitional measurements specific to the Obstetrical exam. Use this package to: » Define additional measurement labels for feta! age end weight estimation + Compare growth parameters using graphs and charts * Collect report data over the durstion of a pregnancy «Perform first-trimester measurements and calculations «Prepare @ separate report for each twin for dual gestetions. 1-18 lm SOMOLING PRIMA OPERATING INSTRUCTIONS eweuonmeenEMAPTER 1 Introduotion, Safety, end Care Presets and Customization ‘The Prima imaging system includes software that can be used to set up and configure the imaging system to support your diagnostic requirements. This software provides yau with menus to define default settings, or presets, for your imaging preferences. System presets are defined using the fullscroen General System Set Up menus. ‘You can assign presets for the settings you use most frequently, or specify the ‘exam type to which the system defaults st startup. Use the Generst System Set Up menus to customize the followi + General system setup + Gram settings + Transducer settings + Pictograms + Text annotation "Calipers: * Calculatior/measurement settings and reports "Display of motion (M-mode) with images + Herdcopy setup « Intemalfexternal device setup + Language selection + Trackball behavior ‘Your imaging preferences and presets can be stored on diskette and loaded into the system as needed. using the Disk Utiity function. Quick Sets You can use the Quick Set feature to capture an optimized configuration of imaging settings for a specific transducer ard exam type. Quick Sets are pprovidied in addition to the system presets. See Chapter 6 for ¢ description of ‘the options provided by the Quick Set feature. etmemvoanves SONOLINE PRIMA QFERATING INSTRUCTIONS mult) 119CHAPTER 1 Introduction, Selety, and Cere System Symbols ‘The table below is provided for your identification of important symbols located im fabels on the Prima system. NOTE: The Type B, Type BF, and Type CF Patient Connections are defined by IEC 601-1, Symbol Explanation Symbol Explanation Aa Mtowatea Curent © Safety Grourd Caution: High Voitage: ® ‘Signal Ground: Type BF Detonator groot Locsion of Patent Connection Removable Air Vent Cover Type BF Pationt = , ashen Bectronie (Curved ‘or Linear) Array ‘Transducer Port ‘Type 8 Patient k Conrestion Mechanical Sector = —Z Transcucer Port Type CF Patient Connection A ECG Socket Consuit Operetor's Manual a Eauipotentia Connection 3 Unlocked Pesition > Footswiter Connector Locked Position 1-20 mm SoNOLINE PRIMA OPERATING INSTRUCTIONS seerencorteranCHAPTER 1 Introduction, Safety. and Care Controt Panel Overhead Light on Under Side of Monitor Morito: Contrast Tapinaton Sebel Exvansion ] 5) Tit are Swive! Lock on forte Monto" oF Montor Removal Lock sundoy OFF Pertal System ON Partial System tandby OFF Parte! System OFF —_—| Mositor Brightness Signal Input ‘Signal Output ‘Transducer Holder Postions for Supporting Transducer Digital interface SONOLING PRIMA OPERATING INSTRUCTIONS min 1-21CHaPTeR 1 Introduction. Safety, and Ca Biohazard Considerations WARNING: Only rrensdlucers marked Type CF are suiteble for direct cardiac contact. WARNING: For neonotal head imaging, Siemens recommends that you exercise ‘special care dunng neonatal caphalic scanning to avoid possible damage to the posterior region of the eye, The ultrasound energy emitted by the transducer ‘easily penetrates the fontanels of the intent, WARNING: Sismens makes every affort to manufacture safe and effective ‘wensducers. The user must take care to prevent the transfer of infections between patients, operators, and third parties. eter to the Cleaning and Disintection procedures in this chapter. ‘Same transducers sre accompanied by instructions that recommend the use of protective transducer covers. Safety precautions should ba implemented in ary ‘application that requires endovaginal, encorecta, or ntraoporauve scanning, during ionsy or puncture procedures, or when scanning patiems with open wounds. WARNING: Horo we would like to inform you that contact with Latex (natural ‘rubber! may cause allergic reactions, For this reason, a possible sensitwity of ‘patients to Latex should be tested and treatment of allergic reactions must be Prepared accordingly. WARNING: Ultasouns energy is transmitted more effectively through water than through tissue. When using a standoff device of any kind, for example, & waterpath, the actual mechenical and thermal indices, Ml andlor Tl, may be higher than indicated in the outout display on the system, Uttrasound is considered safe at tow clinical power levels. The safety limits of higher levels ‘and longer periods of exposure to uitrasound are not yet completely known. Because the assessment of the biological effects of diagnostic ultrasound on humans will not be ‘completed for some time, this product, and all diagnostic vitrasound procedures, should be used for valid reasons, for the shortest possible period of time, and at the lowest power setting necessary to produce clinically acceptable images. According to the principles of ALARA (As Low As Reasonably Achievable), the eneroy rediated should be the /owest jevel ‘requeed to satisfactorily perform the examination. Fot more information, refer to Transmit Power Levelon page 1-23 1-22 num SOMOLINE PRINK OPERATING INSTRUCTIONSCHAPTER 1 Introduction, Safety, and Care ‘The SONOLINE Prima uttrasound imaging system complies with the standards of the American institute of Uhrasound in Medicine (AIUM), the National Electrical Manufacturer's Association (NEMA), and the United States Food and Drug Administration (FDA) in terms of safety and acoustic power output levels. The ultrasound output power levels are stated to ‘permit the user to critically evaluate the system settings in the event of new research findings being announced. Refer to Appendix B for information concerning acoustic output intensities. The effects of difierent imaging functions on acoustic output are explained on page 1-26. seeevrn® SOMDLINE PRIMA OPERATING INSTRUCTIONS mi 1-23CHAPTER 1 Introduction, Safety. and Care. Transmit Power Level! WARNING: Uttrasound procedures should be used for valid reasons, for the shortest period of time. and at the iowest power setting necessary to produce clinically acceptable images. Power Control Acoustic power is the amount of energy applied directly to the patient. The POWER, ccantiol on the control panel adjusts the acoustic output power delivered from the ‘transducer 10 the patient. The POWER control determines the transmitted levei of Ultrasound for all ansducers and imaging modes during real-time imaging. The range and especially the maximum level of acoustic Rewer will differ depending on the ‘transducer. In addition, each diagnostic exam type has preset power vaiues. Extreme care should be used when increasing the transmit power above the preset limits. To adjust the transmit power: + Toincrease the tansmit power, rotate the POWER contol clockwise. When the maximum power level is reached, the imaging system om emits 2 beep. \ + Todocrease the transmit power, rotate the POWER control counter- LU clockwise. When the minimum power level is reached, the imaging system emits @ beep. ‘The transmit power ranges from a minimum of -24 dB to a maximum of 0.43 in 3-48 increments. Sefecting 0 dB, or 100%, trensmits the maximum accustic power for each transducer, where: loons: <720 mem? and Mi: <1.8 ‘You can use General System Set Up Menu 1 to determine whether the power value is displayed in decibels (dB) or as a percentage of the maximum power (%}. The exampie below shows one value expressed in both formats, Refer te Chapter 6 for information on setting the power display format. Display Formet System Status Menu Systam Status Parameter Feld 0B Outpt 648 85/1 /2/32/-6 % Outpur 26% 55/1/2/32/25 1-24 mm SONOLINE PRIMA OPERATING INSTRUCTIONS see onmnaevesCHAPTER 1 Introduction, Safety, and Care Transmit Power Display i aapnatgaaaye 9-668 Bae Ka ‘Tee power value is oisplayedin the System Status Menu and inane System ‘Status Parameters tield on vie bottom fet of te maging scree ‘The System Status Paremeters field displays the following information for the active mode. at all times, to define how the image was obtainad: B: 55 /1/2/32/-6 B-mode: Dynamic Range / Persistence / Edge Enhance / Gain / Output Power M: 35/0/2/29/-6 M-mode or B/M-mode: Dynamic Range / Persistence (stways 0 in M) / Eoge Enhance / Gain / Output Power NOTE: in B/M-mode, the System Status Parameters field only shows the values for Mt. ‘mode. The corresponding 6-mode parsmeters are rot shown, and cannot be changed. The B-mode settings must be configured before the system enters M-mode. This cispiay is updated es the POWER controls turned. Each time the power level is changed, the displayed parameters are shown in inverse video for one second. Refer to Chapter 2 for specific information Mechanical and Thermal Indices Mechanical and Taermal Indices of 0.4 or more are cisplayed in the lower right edge of the image screen in ail imaging modes. These fields are not Trackball selectable. The following indices can be displayed: MI = Mechanical index TIB_ = Bone thermal index for fetal applications TIS = Soft tissue thermal index Roer to Appendix B for specific information, scesomannentves SOMOLINE PRIMA DPERATENG INSTRUCTIONS Min 1-25CHAPTER 1 Introduction, Safety, and Cars Imaging Functions that Change Acoustic Output Changes of imaging mode and adjustments to controis also affect the output power, ‘Specific information is provided in the following table. ‘Operation Efiect on the acoustic output Transducer change ‘The maximum acoustic outeut of each transducer is optimized to rocucs the best image quality within FDA guidelines. Thus, the acoustic outaut will change as the operator changes the sctive sransducar. Imaging Mode change ‘Since B- and M-modes use different defeuit imaging perameters, changing the moce will change the acoustic ouput power of the ‘system. No changes occur when switching from B to 26 or 43, since ‘the basic imaging parameters rerrsin the same, In mast cases, the acoustic output power for N-mode is larger than in B-mode, however. it depends an the specific presets for B and M-mode. Field of View (Sector Angle or Scan Wicth) ‘Changing the sectar angie or scan wicth may result in changes to the frame rate, and thus change the ecousti¢ output Image depth change ‘Changing the image depth changes the PAF, and thus changes the acoustic output. Number of Focal Zones ‘Since tne number of focal zones influences the frame rate and the ‘ctuel position of the focal zones, changing the rumiber of focal zones changes the acoustic ourput. Focus location ‘The transmit focus location change will cause the acoustic output ‘change, even though the ter'smiting electrical anergy level and the aperture remains the same. In most cases, the acousile power Wil! increase if the focal point is moved cioser to the transducer. Zoor ‘Activating 200m may change the focal depth and aperture. The worst ‘case acoustic output condition is ftom the largest transmit aperture at a given depth. Thus, acoustic outout changes depending on the 200m location, Freeze Activating the freeze function stops the electrical energy transmit part (of the system, thus disabling the system from generating ultrasound, ‘Automatic Time-cut ‘Transmit power ‘When the Prima is inactive ‘ora selectable time period, the system. ‘automaticaly freezes and cisplays the screen saver. Activating the freeze function stons the electrical eneray transmit part of the system, ‘thos gisabiing the system from generating uitrasounc., The timeout can bbe specified using the General System Set Up menus. The transmit power level change will change the electrical cutout of the system to the Yransducer, and thus change the acoustc autout. Frequency change (Changing the operating frequency changes the focal characteristics of the acoustic waves, thus changes the acoustic output Une Density [Changing the number of acoustic Ines generated lIne density) atfects the acoustic output, 1-25 WM SONOLINE PRIMA OPERATING ENSTRUCTIONSCuHapreR 1 Introcuction, Safety. and Care Operation Eft on the acoustic output Frame Rate Wah increase of the frame rate, the acoustic power output increases, Preset Since the system and user presets contain all of the above imaging parameters, changing the preset will change the acoustic output power Reset or Power OfffOn | Resetting or powering the system on or off causes the system to return {© the default status, thus may change the acoustic output, Use of a waterpeth When using a standoff device of any kind, the actual mechanical snd ‘therma! indices, Mit andlor Tl, may be higher than indicted in the. output display on the system stesuaracnevan SONOLINE PalMA CPERATING INSTRUCTIONS mii 1-27CHAD TER + Introduction, Safety, and Care Etectrical/Environmental Safety Requirements WARNING: For 115Y systems, in order to ensure grounding refiabilly, connect the system only to.a hospitat-grade receptact. Power Supply Nominal Voltage Nominal Frequency _ Pewer Consumption 18v 50/60 He 3.0 amps* 230V 0/60 He 1.5 amps Environmentai Specifications Relate humisty 30 10.85%, non-condensing, during operation Temcerature System 10°C to 440°C, operating -20°C 10 +60°C, ambient (storage) Transducers: Type Operating Storage Curved anc Linear Armay HOC to 420°C 10°C to +80°C Mechanical Sector SI 418°C to 440°C 40°C to 440°C Endov +20°C10 +40°C 5°10 +50°C Endo Il HIST 0 -A0FC 10°C 10 +60"C Micro Sector +20°C to 280°C SC to +50°C. ‘Meximum Altitude Operation up to 3,000 meters 1-28 mM SOMOLINE PRIMA OPERATING INSTRUCTIONS appvCHAPTER 1 Introduction, Safety. end Care Use of Peripheral Devices WARNING: Accessory equipment connected to the analog and digital interfaces must be ‘certified accoraing to the respective IEC standards (2.9., IEC 950 for deta processing equipment and 1EC 601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard 'EC 601-1-1. Anyone who connects additional equipment to the signal inout or signal output part configures 2 medical system and is therefore responsibie that the system complies with the requirements of the system standard 1EC 601-1-7. Siemens can enly guarantee the performance and safety of the devices listed in Aopencix D. if in doubt, consult Siemens service department or your local Siemens representative. Refer to Chapter 8 for information on connecting peripheral equipment to your Prima imaging system. seemucne SQNOLINE PRIMA OPERATING INSTRUCTIONS mil 1-29CHAPTER 1 Introduction, Safety, and Care Equipment Care The equipment care information provides appropriate care instructions for the following: «Prima imaging system * Trensducers and accessories NOTE: Documentation and storage devices are accompanied by their manutecturers; instructions for equipment care. Refe’ to Cleaning and Disinfection on page 1-37 for detailed cleaning instructions. 2-30 ltl SONGLINE PRIMA OPERATING INSTRUCTIONSCHAPTER 1 Introduction, Safety, end Care Caring for the Prima Imaging System The user is responsible for verifying that the imaging system is safe for diagnostic ‘operation. Each day, prior to using the system, perform each of the steps in the Daily Checklist to ensure that the system is safe for operation. NOTE: Ail exterior parts of the system, including the control pane, transducers, and biopsy devices, should be cleaned sndicr disinfected as necessary of ketweon uses, Clean each component to remove any surtace particles, Disinfect components to kill vegetative organisms and viruses. Daily Checklist Perform the following checklist items each day before you use the system: Visually inspect all transducers. Do not use a transducer thet has @ frayed cabie of a cracied, punctured, or discolored casing. Visually inspect the power cords. Do not tum on the power if the power cord is frayed or split, or shows signs of wear. DVerify that the control panel, including the trackball and DGC controls, appears clean and free from gel or other contaminants. ‘Once the system is powered on: Verify that the monitor displays the current date and time. Verify that ine transducer identification indicated on the transducer agrees with the transducer identification displayed in the System Status Menu. seoemucnetern SONOLINE PRIMA OPERATING INSTRUCTIONS 1-31CHAPTER 1 Introguetion, Safety, and Care Maintenance ‘Maintenance for the Prima imaging system should be performed every 12 menths. Electrical safety tests must aiso be performed at regular intervals in accordance: with safety regulations, or as required. ‘Siemens Authorized Care instalers and operaters must observe all regulations that govern the installation, ‘operation, inspection, and maintenance of this equipment To ensure the sefety of patients, operators, and third parties, the equipment must be inspected every 12 months, and replacement of parts performed as Recessary. This maintenance must be performed by 2 qualified Siemens service Tepresentative. It is important to inspect the equipment more frequently if tis ‘operated under extraordinary conditions, Itis important to pertorm inspection and maintenance at the prescribed intervals to avoid allowing ony part of the system to become hazardous dus to wsar, Contact the Siemens service department for information regarding the required maintenance. ‘As manufacturers and installers of ultrasound equipment, Siemens cannot assume responsibility for the safety properties, reliabilty, and/or performance of the equipment, if: = Extensions, readjustments, macifications, additions, or repairs are carried cut by persons not specifically authorized by Siernens. + Components that affect the sate operation of the system are replaced by Parts not authorized by Siemens. + Electrical instatlations of the room where the equipment is located co not meet the power and environmental requirements stated in this manual. + Equioment is not used in accordance with the related operating instructions. ‘+ The system is operated by personne! not adequately educated or trained, ‘Siemens suggests that you request any person who performs maintenance, of repairs, to provide you with a certificate showing: «The nature and extent of the work performed * Changes in rated performance * Changes in working ranges + Date of service = Name of person or firm performing the service * Signature of person performing the service Technical service documentation pertinent to the imaging system is available at an additional charge. Providing this cocumentation does rot in any way constitute an autharization to conduct repairs or maintenance. Siemens refuses all responsibilty for repairs that are performed without the express written consent of the Siemens service department 1-32 iM SOWOLINE PRIMA OPERATING INSTRUCTIONS semvacra,CHAPTER + Introduction, Safety, and Care Caring for Transducers WARNING: Always place 2 sterile transducer cover on 3 transducer used in an endocavity ‘exem, a procedure using intraoperative transducers, or other procedures requiring sterility The use of transducer covers is discussed on page 1-34. Do net sterilize trensducers using hot steam, cold gas, or Ethylene Oxide ETO) methods. See page 1-37 for cleaning and disinfecting procedures. WARNING: There have been reports of severe aliergic reactions to medical devices Containing latex (natural rubber). Health care professionals are advised to identity latex- Sensitive patients and to be prepared to treat allergic reactions promptly. In the USA. refer to FDA Medical Alert MOAQi-1. CAUTION: Transducers are mechanically sensitive Instruments and must be handled corefuly. Do not use a transducer that has been dropped or shows signs of mechanical ‘compromise, Do not attempt to repair or alter any part of the wensducer. CAUTION: To avoid damage to the transducer, do not use petroleum- or mineral oitbased ‘utrasound coupling agents, Use only a weter-based ukrasaund coupling agent. ‘Take extreme care when handling or storing transducers. They must not be dropped, jarred, or knocked against other objects. Do not let transducers come into contact with any sharp-edged or pointed object. Protective Case Due zo the mechanical sensitivity of transducers, Siemens recommends that you ‘always use the transducer case when you ship or transport @ transducer from one: place of examination to another, The case is specially designed to protect the sensitive parts of the transducer. Be sure that all parts of the transducer are property placed inside the case before you close the lid, Storage ‘Store iransducers in a ciean and ary place according to the ambient temperatures listed for each transducer type on page 1-28 and up to 80% relative humidity at 40°C. Extreme temperatures or humidity can damage a transducer. semmavenereves SONOLINE PRIMA OPERATING INSTRUCTIONS mi 1-33CkerteR 1 Intraduecion, Safety, and Care Caring for Transducer Accessories Care instructions are provided for the following transducer accessories: © Transducer covers = Waterpath standoff kits "Needle guide bracket kits Transducer Covers WARMING: There have been seports of severe allergic reactions to medical devices ‘containing otex (natural rubber). Health care professionals are advised te identity latox sensitive patients and to be prepared to treat allergic reactions prompty. in the USA, refer to FDA Medical Alert MDAST-1 Use a cisposable transducer cover on a transducer to reduce the possibility of cross-contamination. Always use & protective transducer cover for endocavity and intraoperative exams, curing biopsy or puncture procedures, and when ‘scanning an open wound or an area where the skin is not intact. Storage CAUTION: Do not store latex transducer covers where damage from ultraviolet ight can result. Latex proaucts have a limited shel life and should be stored in a cool, dry, dark place. Before use, examine these covers for any material flaws. Some eckaging may list an expiration date. Do not use, and dispose of properly, any product showing flaws or an expiration date that has passed, 1-34 nm SOWGLINE PRIMA OPERATING INSTRUCTIONS cecum neCHAPTER 1 Introduction, Safety, and Care Waterpath Standoff Kits WARNING: Thero have been reports of severe allergic reactions to medical devices ‘containing latex tnatural rubber). Health cere professionals are advised ta identify. latex-sensitive patients and to be prepared to teat allergic reactions promptly. In the U.S.A, refer to FDA Medical Alert MDAQI-1. CAUTION: Use only water-soluble ultrasound coupling agents with a waterpath kit. Petroleunr of mineral oi-based materials can harm a weter biedder and the transducer, ‘Waterpath standoff kits are available for specific transducers. Refer to. Appendix D tor a list of the kits that are available by ‘rnsducer name. Ackit typically contains a bracket and wetersiadders. Before use, examine the ‘components of the waterpath kit for any material flaws. Damage is indicated by thinning, bulging, or brittleness of the latex material. Any product showing flaws should not be used. Storage CAUTION: Do not store waterbladers in airact sunlight, as damage from ultraviolet ont can result. Always clean the waterbladder after each use. Prior to storage, the waterbladder should be emptied. Latex products have a limited shelt life and should be stored in a cool, dry, dark lace to prevent premature deterioration. After cleaning. thoroughly dry the bledder and place it on plain white paper, as latex tends to stick to other material, Needle Guide Bracket Kits WARNING: Needte Guide Bracket Kits are packaged as nonsterie. Steriize these products prior to their first use. Refer to the sterlization procedures beginning on page 1-42. Needle guide bracket kits are avaliable for specific transducers. Refer to Appendix D for 8 list of the kits and devices that are available by transducer name. Storage Always clean and sterilize components that are used in a needle puncture or biopsy procedure before storage. mena SORGLINE PRIMA OPERATING INSTRUCTIONS mull 1-35CHAPTER 1 Introduction, Safety, and Care Caring for Documentation and Storage Devi CAUTION: Do not remove the mounting brackets of covers thet secure documentation devices 10 the system. For information en the care of an optional documentation or storage device. refer to ‘the manufacturer's operating instructions provided with the device, ‘The cocumentation devices for the Prima imaging system that are mounted internally are designed to have secure mounting brackets and/or covers to ensure safety when the imaging system is transported or moved, 1-96 unm SOWOLINE PRIMA OPERATING INSTRUCTIONSCHAPTER 1 Introduction, Safety, and Care Cleaning and Disinfecting You must take all necessary precautions to eliminate the possibilty of exposing Patients, operators, or third parties tc hazardous or infectious materials. Use universal precautions when cleaning and disinfecting. You should treat all Portions of the imaging system that come in contact with human blood or other ody fiuids as if they were known to be infectious. Alll exterior parts of the system, including the control panel, transducers, and biopsy devices, should be cleaned and/or disinfocted as necessary or between uses. Clean each component to remove any surface particles. Disinfect the components to kill vegetative organisms end viruses Cleaning and infecting the Prima Imaging System WARNING: To avoid the possibilty of electric shock ano damage to the system, turn off and disconnect the equigment from the power receptacie before cleaning and disinteeting. WARMING: To avoid heatth hazards, comply with the disinfectant manufacturer's instructions. CAUTION: To avoid the possibilty of static shack and damage to the system, void the use of aerosol spray cleaners on the monitor screens. CAUTION: Do not clean the system with chlorinated or aromatic solvents, acioie or ‘basic solutions, or strong cleeners such as ammoniated produets. as these can damage the surface of the system. Use the cleaning procedures described beginning on page 1-37. CAUTION: Do not use spray cleaners on the system. or pour fluid onto the system ‘surfaces, as fluid can saep into the systam and damage electronic components. ft is also possible for the solvent fumes to build up and form flammable gases or damage internal companents, messes SONOLINE PRIMA OPERATING INSTRUCTIONSCHAPTER 1 Introduction, Safety, and Care To clean the surface of the system: 1. Tum off the system and disconnect it from the power receptacle. 2. Use 2 clean gauze pad oF lint-tree cloth, lightly moistened with a mild detergont, te wipe the surface of the system. Take particular care to lean the areas near the trackball and the DGC slide controls. Ensure these areas are free of get and any other visible residue Be sure cieaning solution does not seep into zhe contro! panel keys, keyboata, or any other openings. 3. After cleaning and disinfecting, reconnect the system to the power recontacie. ‘Occasionally, lint and gel may collect around the trackball To clean the trackball: 1. Use a soft, dry brush, like @ toothbrush, to remove dried particles from the area around the trackball 2. Wipe the entire surface of the trackball with a lint-free gauze ped, lightly moistened with a mild solution of water and detergent. To remove and clean the holders for transducers and coupling gel: 1. Tum the transducer holder to the unlocked position and lift the holder cut of the system enclosure, 2. Wash the holder under running water, using a mild detergent. 2. After cieaning, reattach the holder to the system. 1-38 nm SONCLINE PRIMA OFSRATING INSTRUCTIONS ssvooreveCHAPTER 1 Introduction, Safety, and Care To remove and clean the holding tray for the endocavity transducer: 1. Press the two latches on the tray to release it from the system enclosure. 2. Wash the holder under running water, using ¢ mid detergent, 3. After cleaning, reattach the holder to the system. ‘The filters for the Prima system should be cleaned every six weeks, of as Fequired by environmental conditions. To clean the system filters: 1. Tur off the system and disconnect it from the power receplacie Access the filters, Pull the filter straight away from the plastic filter frame. Rinse the filter, using flowing cold water, to remove any lint. Shake excess water from the ‘fitter and allow it to dry before reinstalling. After cleaning, reconnect the system to the nower receptacle, oe PONS se scevononevea SONOLINE PRIWA OPERATING INSTRUCTIONS mri 1-39CHAPTER 1 Introduction, Safety, and Care Cleaning and Disinfecting Transducers WARNING: To avoid electric shock anct damage to the system, disconnect the ‘transducer prior to cleaning or disinfecting. WARNING: To avoid cross-contamination, endocavity and intraoperative transducers ‘must be cleaned and high-level disinfected after each use. CAUTION: To avoid damage to the transducer, do not immerse the cable or connector of. transducer. The cable on introoperative transducers is immersible, CAUTION: The transducers have been designed and tested 10 be able to withstand high-level disinfection as recommended by the menutecturer of CIDEX™. Carefully tollow the disinfectant manutacturer’s instructions, Do not immerse transducers for ‘moe than one hour. CAUTION: Do not sterilize transducers using hot steam, cold gas, oF Ethylene Oxide mechods. Never autoclave a transducer. CAUTION: Do not use abrasive cleaning products, organic solvents such as benzene, ‘alcohol. oF @ phenol-based substance, or cleaning agents containing organic solvents to disinfect wansducers. These substences can damage the transducers, CAUTION: Do not use e spray cleaner on a transducer, as this can force cleaning fluid inside the housing and damage the transducer. ‘All transducers shouid be cleaned and disinfected prior to their use on each patient, Endocavity and intraoperative transducers require high-lavel disinfection prior to use. 1-60 mmm SOWDKINE PRIMA OPERATING [NSTRUCTIONSCHAPTER 1 Introduction, Sataty, and Care To clean and disinfect @ transducer: Disconnect the transducer from the system. 2. Moisten a clean gauze pad with water and wipe the transducer to remove any gel oF particles remaining on the transducer. 3. Carefully Wipe the entire transducer, including the cable and connector. 4. To disinfect the transducer, take care to keep the cable and connector of ‘the transducer dry while immersing the transducer in CIDEX™ , as illustrated on page 1-42. Carefully follow the disinfectant manufacturer's instructions, 5. After cleaning or disinfecting, use a clean paper towel to dry the transducer. verano ve SOMOLINE PRIUA ODERATING INSTRUCTIONS mlCHAPTER 1 Inteduction, Satety, and Care To perform high-level disinfection: 1. Thoroughly clean, rinse, and dry the transducer. 2, Take care to keep the cable and connector of the transducer dry while immersing the transducer in CIDEX™. Caretully follow the disinfectant ‘manufacturer's instructions. For high-level disinfection, immerse the wransducer in CIDEX™ for the amount of time recommended by the disinfectant manufacturer. 3. Using sterile techniques, remove the transducer from the solution, 4. Thoroughly rinse the transciucer with the amount of sterile water recommended by the disinfectant manufacturer. 5. Sree tnedcea sre eanmen betwee Hl JA BSEVI3 Endocavty Linear Cuwved Micro Mechanical Intraoperative Secter Sector C Immersion ievels for wonscucers NOTE: Intraoperative transducers are immersible up to the strain relief on the connector 1-42 jum SONOLINE Prima OPEseTING LHSTRUCTIONS sara tno 00cuapTER 1 Introduction, Safety. and Care Cleaning, Disinfecting, Transducer Accessories ind Steril WARNING: Ensure that the accessories for a transducer are properly cleaned, sterilized, or disiniected as appropriate after each use to avoid passible patient contamination Refer to Chapter 11 for a description of how to attach waterpath standoff kits and needle guide brackets to your transducer, Waterpath Standoff Kits CAUTION: Do not steriize the waterpath components using hot steam, as damage can result. ‘Wash the waterbiadder and bracket with a mid detergent solution after each use, Dry the waterbladder shoroughly before storing. Disinfect the waterpath bracket using CIDEX™. Carefully follow the disinfecient manufacturer's instructions. For high-level disinfection, expose the waterpath bracket to CIDEX™ for the ‘amount of time recommended by the disinfectant manufacturer. Needle Guide Bracket Kits Specific transducers for the Prima imaging system ere compatible with needle guide bracket kits. Instructions follow for the cleaning and sterilization of each kt, Needle guides should be cleaned and sterilized following each use. Si, S-Array, and Endocavity Needle Guide Bracket Kits WARNING: The noodle guide holder should fit securely against the needle guide ‘bracket. Evaivate the fit of the needle guide holder and bracket prior to each uso. After continued use, the fit of the needle quide holder 10 the bracket wil deteriorate. ‘Shouid this occur, please replace the S-Arcay Needle Guide Bracket Kit. Agpendix D {ists part numbers. Prior to sterilization, rinse the needle guide under water, and then scrub the inside of the guide with » brush. Visually inspect the guide to make sure all debris is removed Sterilize the bracket and needle guide sets using steam at a temperature of 121°C to 123°C for an exposure time of 15 te 30 minutes, This is a gravity- displacement steam sterization method samara teves SONOLINE PRIMA OPERATING INSTRUCTIONS mim 1-43CHA®TER + Introouction, Safety. and Care Universal Needle Guides Prior to sterization, clean the universal needle guide bracket and inserts) using an enzymatic cleaner, NOTE: After extended exposure 10 steam sterilization, the lack on the bracket may ‘become difficult 1 fack and/or untack. Should this occur, please replace the bracket with a new Universal Needle Guide. Anpencix D lists part numbers. To clean the universal needle guide: 1 Rinse the bracket and insert(s) with water, ‘Soak the bracket and insertis) in an enzymatic cleaner Carefully follow the manufacturer's instructions. Rinse the bracket and insert(s) with water to remove any debris and remaining cleaner. To sterilize the universal needle guide: yeaa, Steriize the bracket and needle guide insert(s) using a wrapped, gravity- displacement steam steriization at a temperature of 121°C to 125°C for an exposure time of 18 to 20 minutes, tu SONOLINE PRIMA CPERATING INSTRUCTIONSSONOLINE PRIMA OPERATING INSTRUCTIONS Wil Chapter 2 System Controls a Contents Control Panel... “ Control Panel Lighting Keyboard... Function Keys. Special Keys Trackball. Freeze Caliper SelectiorEntry Controls, SET NEXT sss ESCAPE... Imaging Mode Control B. 2B... 48 Man SWEEP... UR FLIP. Imaging Function Controls... uc Serene FREQUENCY. POWER... B/M-GAIN. DEPTH, DYNAMIC RANGE .. osc. FOCUS. z00M nsec SONOLINE PRIMA OPERATING INSTRUCTIONS win 2-1emarreR 2 System Controls Special Function Controls. BIOPSY . PICTOGRAM......... Documentation and Storage Control PRINT PRINT 2 CINE. bis: ver Additional Contro) Functions Footswitch... WON OLIVE PRIMA OPERATING FwETRUCTIONSCHAPTER 2 System Controls Introduction ‘This chapter dascribes the Prima imaging system's control panel, including the keyboard and function keys, the trackball, and each of the operating controls and contro! keys. The optional footswitch can also be used 10 controt some functions. Cn Control Panel The Prima imaging system's control panel contains controls for imaging furetions. The layout allows you to work efficiently, performing basic operations with a minimum number of steps, ‘The contro} panei contains a keybosrd with funetion keys, a trackball, end logically arranged groups of special keys, rotary knobs, and slide controls, including: «Power control "Transducer controls = Imaging mode contrais, ‘+ Imaging function controls, including DGC assignment ‘+ Documentation and storage controls. ‘The controls on the Prima system control panel for the 775V version, are labeled with an icon and English text. The controls for the 230V version are labeled only with icons. Both versions of the contra! panel are described in this chapter. ssn fev SOMGLINE #RIMA OPERATING INSTRUCTIONS Min 2-3