5 > e G Q E 3 oO 2 a es S z < Operator's Manual 9-50-0275COPYRIGHT NOTICE This document is copyrighted by LORAD Corporation. No part of this document may be reproduced, transmitted, or copied without the express written permission of ‘36 Apple Ridge Road, Danbury, CT. 06810 Phone:(203) 207-4500 Fax:(203) 207-4501 ‘The following are registered trademarks of LORAD: Lorade LORAD DSM LORAD Elite? StorooLoc? ‘SmartWindow® ‘ScoutMarc? StereoGuide® MuttiCare® Dataport® AutoFilm 10° HTC® Imaging System Cooeeeeeeos Operator’s Manual M-IV Mammography Systems Second Edition Part Number 9-500-0275 Revision 2 This manual applies to M-IV Mammography Systems manufactured after August 2001. For systems manufactured before August 2001, use part number 9-500-0169. LORAD Corporation 36 Apple Ridge Road Danbury, CT 06810 USA Copyright® 2001 by LORAD, A Hologic Company. Alll rights reserved.Co REVISION HISTORY REV DATE MODIFICATION PAGES AFFECTED Rev 1 8/22/2001 Initial Release of 2* Edition ALL Rev 2 9/05/2001 Incorporated Review Comments, Revised Specifications, Restructured Manual ALLM-IV Table of Contents List of Figures .. List of Tables Preface 1.0-Manual Arrangement . xvi 2.0-Warnings, Cautions and Notes Chapter 1: Introduction ..... 1.0-Intended Use 2.0-System Overview 3.0-Manual Objectives .. 4,0-Major Parts and Components .... 4.1-The Operator Console 4.2-The Gantry .. 5.0-Safety Notes .. 5.1-Technologist and Patient . 5.2-Electrical Safety .. 5.3-Mechanical Safety 5.4-Radiation Safety 5.5-Emergency OFF S\ 5.6-Interlack System .. 6.0-Compliance Requirements 6.1-Responsibility Statement .. 6.2-Compliance Statement .. 6.3-Label Locations ...M . IV S (ojo MEU Chapter 2: Accessory Set Up and Installation 1.0-Power and Data Connections 2.0-Power Up Sequence 2.1-Pre-Power Up Checks 2.2-System Power Up «... 2.3-Post-Power Up Checks 3.0-The Image Receptor Support Device 4.0-The Bucky Device 4.1-Installing and removing the Bucky Device ....14 4.2-Loading and unloading the Bucky Device .....14 5.0-The Magnification Table 5.1 -Installing the Magnification Table .. 5.2-Loading the Magnification Table 6.0-Compression Paddles .. 6.1-AEC Sensor akines 6.2-Mounting and Removing the Compression Paddles 17 7.0-Radiation Shielding . 7.1-The Patient Face Shield 7.2-The Operator Shield 7.3-Other Shielding 8.0-Dual Function Footswitches ......... 8.1-Operating the Footswitches . 9.0-Film Labeling 9.1-The AutoFilm ID 9.2-The Label Printer (optional) .. 10.0- Optional Equipment .. 10.1-The LORAD StereoLoc II Blopey System 10.2-The LORAD DSM ...........M- IV a Operator's Manual Chapter 3: System Controls 1.0-Operator Console Controls .. 1.1-The Alphanumeric Keypad . 1.2-The View Keypad ... 1.3-The Exposure Technique Keypad .. 1.4-The Function Keypad 1.5-Other Console Controls 2.0-C-arm Controls ... 2.1-C-arm Up and Down Controls .. 3.0-Compression Device Display ... 3.1-Compression Thickness Display 3.2-Compression Force Display ... 3.3-Automatic Exposure Control Sensor Po: 39 4.0-Tubehead Controls .. 4.1-C-Arm Rotation Switch .. 4.2-Collimator Lamp Button 4.3-Collimator Override Button 5.0-Gantry Controls and Indicators 5.1-The Emergency OFF Switch .. 5.2-The Input Power Circuit Breaker ... 5.3-C-Arm Angle DisplayM-IV i Operator's Manual Chapter 4: User Interface—The Run Mode 1.0-User Interface Overview 1.1-The Start-up Screen .... 1.2-The Run Mode Screen 2.0-The ID Column Data Fields 2.1-The ID Data Field 2.2-The Name Data Field 2.3-The Birth Date Data Field . 2.4-The Sex Data Field . 2.5-The Comment Data Field 2.6-The Tech ID Data Field .. 2.7-The CPT Code Data Field . 2.8-The Exam View Data Field 2.9-The Compression Data Field 3.0-The Exposure Technique Fields 3.1-The Mode Technique Field .. 3.2-The Filter Technique 3.3-The kV Technique Field 3.4-The mAs Technique Fiel 3.5-The Density Technique Field 3.6-The Spot Technique Field .. 3.7-The Film Technique Field . 4.0-The Status Column ... 4.1-The Date Status Field .. 4.2-The Time Status Field .. 4.3-The Printer Status Field 4.4-The Auto ID Status Field 4.5-The Compression Release Status Field 4.6-The Receptor Status Field . 4.7-The Collimator Status Field 4.8-The View Reminder Status Field .. 4.9-The Flasher Override FeatureChapter 5: User Interface—The Setup Mode ... 1.0-Introduction ..... 1.1-The Setup Mode Screen 1.2-Selecting Fields and Entering Data 2.0-Setup Window Defaults 2.1-Pre-Compression Force 2.2-Full-Compression Force 2.3-Compression Release 2.4-Collimator 2.5-Default Exposure Mode 2.6-Default Magnification Mode 2.7-View Reminder .. 2.8-Auto kV Window/mAs Table 2.9-Printer 2.10-Auto ID 2.11-Cassette Sense .. 2.12-Retain Patient Data 2.13-Setup Options ... 3.0-Exposure Technique Defaults ... Chapter 6: User Interface—Additional Setup ..... 1.0-User Interface Overview ... 2.0-Defaults - Additional Setup 2.1-Compression Force Units Data Field 2.2-RIS Data Field 2.3-Film 1 Data Field ... 2.4-Film 2 Data Field 2.5-Film 3 Data Field 2.6-Flash Time 1 Data Fiel 2.7-Flash Time 2 Data Field 2.8-Flash Time 3 Data Field 2.9-Date Data Field . 2.10-Time Data Field .. 2.11-Institution Data Fiel 2.12-Institution Address Field 2.13-Tech ID cleared with Clear Key Data Field .. 2.14-Auto ID Contrast Data Field ........ 2.15-Auto ID Offset Data Field . 2.16-Daylight Savings Time Data FieldM.-L) Chapter 7: Patient Pre-Scheduling and Data Storage 1,0-Manual Pre-Scheduling ... 1.1-Entering Pre-Schedule Data .. 1.2-Recalling Pre-scheduled Data 2,0-Automated Pre-Scheduling 2.1-The Bar Code Reader 2.2-Direct Link (Gateway Option) . 3.0-Post Exposure Storage Chapter 8: Clinical Procedures .. 1.0-Sequence of Operation - Contact Exposures 1.1-Pre-power Up Checks 1.2-M-V Power Up ... 1.3-Installing the Bucky Device ... 1.4-Installing the Compression Paddle 1,5-Entering Patient and Exam Information .........80 1.6-Selecting Exposure Techniques ... 1.7-Positioning the C-arm and Patient .. 1.8-Compressing the Patient's Breast 1.9-Positioning the AEC Sensor . 1.10-Taking the Exposure 1.11-Releasing the Patient 1.12-Post-exposure Checks . 1.13-Labeling the Film . 1.14-Making Additional Exposures (same patient) 82 2.0-Sequence of Operation - Magnification Studies .......83 2.1-Pre-power Up Checks 2.2-M-lV Power Up 2.3-Installing the Magnification Table .. 2.4-Installing the Compression Paddle .. 2.5-Entering Patient and Exam Information .. ting Exposure Techniques .. ing the C-arm and Patient .. 2.8-Compressing the Patient's Breast 2.9-Positioning the AEC Sensor 2.10-Taking the Exposure 2.11-Release the Patient2.12-Post-exposure Checks 2.13-Labeling the Film .. 2.14-Making Additional Exposures (same patient) 86 3.0-Sequence of Operation - Spot Exposures .. 3.1-Pre-power Up Checks 3.2-MAV Power UP ww 3.3-Installing the Bucky Device ...... 3.4-Installing the Compression Paddle . 3.5-Entering Patient and Exam Information 3.6-Selecting Exposure Techniques . 3.7-Positioning the C-arm and Patient . 3.8-Compressing the Patient's Breast 3.9-Positioning the AEC Sensor .. 3.10-Taking the Exposure 3.11-Releasing the Patient .. 3.12-Post-exposure Checks 3.13-Labeling the Film 3.14-Making Additional Exposures (same patient) 90 4.0-Other Features .. 4.1-C.arm Rotation Memory... 4.2-Film Labeling .. 5.0-System Shutdown 6.0-Care and Cleaning 6.1-Cleaning and Disinfection 6.2-Recommendations .. Chapter 9: CPT Code and Technologists ID Setup «vss 1.0-CPT Setup Screen 1.1-The CPT Data Entry Fields 1.2-The View Selection Fields 2.0-Technologist ID Setup Screen ..... 2.1-Defining Technologist ID Data ..M-IV Appendix A—System Specifications 1.0-System Specifications ... 1.1-Electrical Input Specifications 1.2-Operating Environment . 1,3-Storage Environment 1.4-Unit Measurements . 1.5-C-arm Specifications 1.6-Compression Specification 1.7-X-ray Tube Specifications 1.8-X-ray Tube Housing ... 1.9-X-ray Beam Filtration and Output ... 1.10-X-ray Collimation 1.11-Light Field Indication 1 1 1 1 12-High Voltage Generator -13-Accuracy, Reproducibility, and Linearity 14-Image Receptors . +15-Automatic Exposure Control (AEC) ..Figure 1-1 Figure 1-2: Figure 1-3: Figure 1-4: Figure 2.2: Figure 2-3: Figure 2-4 Figure 2-5: Figure 2.6: Figure 2-7: Figure 2-8: Figure 2-9: Figure 3-1: Figure 3.2: Figure 3-3: Figure 3-4: Figure 3-5: Figure 3-6: Figure 3-7: Figure 3-8: Figure 3-9: Figure 3-10: C-arm Angle Display . Figure 4-1: Figure 4-2: Figure 5-1: Figure 6-1: Figure 8-1: Figure 8-2: Figure 9-1 Figure 9.2: Figure A-1: List of Figures ‘The M-IV Operator Console. ‘The M-lV Gantry. Emergency Off Switch (typical). Label Locations. Power Configuration The Image Receptor Support Device. ‘Mounting and Loading a Bucky Devic Installing the Magnification Table. ‘MalV Compression Paddles Installing Compression Paddles. Installing the Face Shield... The Dual Function Footswitch . Inserting the Cassette into the AutoFilm ID The operator console. The View Keypad nn. . The Exposure Technique Keypad... The Function Keys x atm Push-button Controls Manual Compression Handwheels Compression Device Indicators Tubehead Button The Emergency OFF Switch... The Start-up Mode Screen The Run Mode Screen .. The Setup Mode Screen The Additional Setup Screen Printer Label ‘AutoFilim ID Label The CPT Setup Screen. : The Technologist ID Setup Screen MalV Dimensions...ManualM- IV : Operato! List of Tables Compression Force . esiaeresnBl Exposure Technique Defaults for Manual Exposure Mode saa RAB: Exposure Technique Defaults for Mag Manual Exposure Mode nnn 7 Exposure Technique Defaults for Auto-Time Exposure Mode .. 67 Table 5-5: Exposure Technique Defaults for Mag Auto-Time Exposure Mode 67 Table 5-6: Exposure Technique Defaults for Auto-kV Exposure Mode .. 68 Table 5-7: Exposure Technique Defaults for Mag Auto-kV Exposure Mode 68 Table 5-8: Exposure Technique Defaults for Auto-Filter Exposure Mode .. " 69 Table A. WV /mA Range . 1107Operator's ManualM-IV. Operator's Manual Preface 1.0 Manual Arrangement This manual is divided into nine chapters as follows: + Chapter 1: Introduction” This chapter provides an overview of the mammography system, including indications for use, parts descriptions, features, and compliance information. Also included are the warn- ings, cautions, and notes pertaining to patient and user safety. + "Chapter 2: Accessory Set Up and Installation” To prepare the unit for use, this chapter details the power up sequence, attachment of acces- sories, installation of patient shielding, and optional accessories. + “Chapter 3: System Controls” Explanations for the use and functions of the Console controls, the Gantry controls, and the Tubehead controls are contained in this chapter. Also discussed are descriptions of readouts and indicators, interlocks and accessory detectors, and various film labeling methods. ‘+ "Chapter 4: User Interface—The Run Modo” This chapter describes the areas that make up the Run Mode screen, and how to move through the on-screen data fields to make selections or to enter information in preparation of a clinical examination. + Chapter 5: User Interiace—The Setup Mode* The Setup Mode screen permits the user to make default selections that will define the status of the system at power up. The selections discussed in this chapter include compression force defaults, exposure mode defaults, exposure timing defaults, and exposure technique defaults * “Chapter 6: User Interiace—Additional Setup” In this chapter, the user learns to make choices that define parameters such as: unit of mea. sure for compression force, RIS capabilities, and screen-film combinations. + “Chapter 7: Patient Pre-Scheduling and Data Storage” Chapter 7 details the methods by which examinations are scheduled: manual scheduling, scheduling via the Bar Code reader, and scheduling via the RIS system (a direct link to the Hospital information System). * “Chapter 8: Clinical Procedures” ‘This chapter suggests a sequence for clinical applications, including procedures for contact exposures, magnification exposures, and spot mammography. * “Chapter 9: CPT Code and Technologists 1D Setup” In this chapter, the user learns the steps necessary to setup CPT codes and to define prefer- tences that customize the Run Mode for each Technologist. + “Appendix A—System Specifications” This chapter states specifications for the product. PrefaceM-IV a eee 2.0 Warnings, Cautions and Notes A, & Definitions of Warnings, Cautions and Notes used throughout this manual are as follows: WARNING! Warnings point out procedures that you must follow precisely to avoid injury to yourself or others. ‘CAUTION! Cautions point out procedures that you must follow precisely to avoid darw. age to equipment, loss of data, or corruption of files in software applications. ‘Note...Notes indicate important information that must be followed to ensure the proper operation of the system. ProfacoM-I¥V 7 Operator's Manual Chapter 1: Introduction 1.0 Intended Use ‘The M-IV Mammography System is intended to produce radiographic images ofthe breast. Its specific intended use is for screening and diagnostic mammography. 2.0 System Overview The LORAD M-IV is an advanced, multiprocessor controlled, ergonomic x-ray mammogra- phy system, Capable of multiple applications, the M-IV functions as a complete diagnostic system utilizing standard image receptors or the LORAD HTC Grid System for film imaging. The M-IV easily converts for use with the LORAD DSM (for digital capabilities), and for use with the LORAD StereoLoc II fr upright stereotactic procedures (Needle Core Biopsy, Fine Needle Aspiration, Wire Localization). ‘The unit’s modular design separates the operator interface (Operator Console) and the patient handling devices (Gantry). This permits configuration of the M-IV to differing space allot- ‘ments including installation as a mobile unit (M-IV Mobile). LORAD Stereotoc I and LORAD DSM are not available for use with the M-IV Mobile. 3.0 Manual Objectives This manual serves a twofold purpose: + Ibis a learning aid for understanding the use and functions ofthe indivi of the mammography system. lual components + Itisan operating guide that assists the user during the clinical application of the system. The manual takes a building block approach that starts with explanations of system basics, and progressively moves the user through the operating controls, to the ultimate goal of per- forming clinical examinations. To better achieve this goal, the user should: + Read this manual in total, and in the sequence in which iti presented, and become familiar with its contents + Keep the manual in an accessible spot for use as a quick reference before and during patient exams. Chapter 1: Introduction i4.0 Major Parts and Components ‘The M-IV Mammography system consists + the Operator Console + the Gantry (with C-arm) 4.1 The Operator Console Cela es eu ‘The Operator Console, separate from the Gantry, is the system control station. The Console’s pedestal-type design accommodates differing room sizes and require- ments. The operator interface appears on a tilting flat panel display, and shows patient information and exposure techniques. A control keyboard is used for input of identificati houses the information and exposure parameters. The Operator Console also itemal AutoFilm ID for film labeling, and a floppy disk drive for elec- tronic storage of exposure history. The console is equipped with LED illumination of the keyboard. 4.1.1 Legend - Operator Console Use the legend below as a guide for component identification. 1. Keyboard LEDs 2. Tilting Flat Panel Display 3. Emergency OFF Switch (lft side of the Console) Keyboard ‘AutoFilm 1D Radiation Shield Bar Code Reader (option) Floppy Disk Drive Cassette Storage (both sides) (0. Input Power / Data Cable Con- rector Panel (rear of the Con- sole) Figure 1-1: The WEI Operator Console Chapter 1: Introductionrator's Manual 4.2 The Gantry ‘The Gantry houses the high voltage electronics which produce x-rays at the energy levels needed for mammography. The mechanical assemblies which position the C- arm (height and rotation), the input transformer, the fuse panel, and most of the sys- tem electronics are also in the Gantry. LED readouts on the left and right side of the Gantry show the C-arm angle. ‘The C-arm houses the x-ray tubchead, the Compression Device, and the Image Receptor Support Device, and mounts to the Gantry via a pivot mechanism. Acces- sories, such as Compression Paddles, Magnification Tables, and Bucky devices, as well as the StereoLoc It and DSM options, are installed on the C-arm to support var- ious applications. The design permits examinations of standing, sitting or recumbent patients. Push-buttons on each side of the C-arm and tubehead control C-arm Up! Down, C-arm Rotation, Compression Release, Compression Up/Down, Light Field Mlumination, and x-ray beam collimation override 42.1 Legend - Gantry Use the legend below as a guide for component identification. 1. Tubehead 2. Tubehead Controls 3. Face Shield 4. Compression Thickness / Force Displays 5. Compression Device 6. Image Receptor Support Device 7. C-arm Angle LED 8, Emergency OFF Switch 9. Patient Handles 10. Vertical Travel Assembly W arm Controls . C-arm Pivot Tube ON/OFF Circuit Breaker 14. Footswitch Figure 1-2: The M-IV Gantry Chapter I: IntroductionOperator's Manual 5.0 Safety Notes Read the following safety notes and precautions before turing the unit on. 5.1 Technologist and Patient ‘Only qualified operators should use this machine. Operators should be well-versed in the basic principles of mammography before attempting to carry out the instructions contained in this manual. This operator's manual should be read and understood in its entirety before turning the unit ON. ALWAYS follow all the instructions in this manual. LORAD does not accept responsibilty for injury or damage associated with improper or unsafe system operation. Your LORAD dealer can arrange for training by a mammographic application specialist at your facility. ‘The MV is designed with state-of-the-art protective devices that are built into the machine's operating logic. However, the technologist needs to be familiar with published data on radi- alion safety, When operating the M-IV, the technologist needs to keep in mind the health hazards of unwanted x-rays. WARNING! For maximum protection from x-ray exposure the operator must Keep her/his entire body behind the radiation shield for the duration of the exposure. WARNING! This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are followed. Observe all operating and safety instructions before making an x-ray exposure. WARNING! It is the responsibility of the user to correct anomalies or abnormal operation of the M-IV before the unit is used, and to arrange for preventive maintenance twice a year by authorized personnel. WARNING! Use care when adjusting for patient use. Observe equipment and patient at all times during set up. Ifa chair is necessary for a procedure, where possible, use a variable height chair set above its minimum height to assist with the set up process. WARNING! To avoid accidental footswitch activation, keep both footswitches clear of the patient and C-arm setup area. Chepier 1: IntoductionM- IV ‘ Operator's Manual 5.2 Electrical Safety Only authorized maintenance staif may remove covers from the M-IV unit. Always refer ser- vice needs to qualified, LORAD-authorized personnel. ‘The system is classified as CLASS |, TYPE B permanently connected equipment as per EC 601-1 and Class i! Medical Devices per 21 CFR 892.1710. There are no special provisions to protect the system from flammable anesthetics or ingress of liquids. WARNING! Lethal voltages are present within the interior of this unit. DO NOT open any of the panels. WARNING! Detergents and disinfectants, including those used on the patient, may form explosive vapors. Always observe the relevant rules regarding dissipation of explosive vapors before operating this unit. Always be aware of the effects static electricity has on electronic components. Take precau- tions for the safe handling and storage of electronic media CAUTION! The floppy diskettes store data magnetically. DO NOT store or place any ‘magnetic media near or on devices which produce magnetic fields or stored data may be fost. 5.3 Mechanical Safety ‘The C-arm rotation motor stops upon loss of power and braking is ensured. ‘The Automatic Compression Release Mode is disabled when a Localization Paddle is installed. All C.arm functions (vertical drive, rotation, compression up/down, compression release, light field, etc.) are simultaneously operable, Vertical drive and rotation are disabled when 13 Ib (60 N) oF greater of compression force is displayed. Chopter 1: Introduction o5.4 Radiation Safety ‘The radiation safety of the unit complies with all requirements of 21 CFR, Part 1020, and complies with IEC 601. ‘The operator control panel contains two x-ray exposure buttons that must be pressed simul- taneously for the entire duration of the exposure and released before initiating another expo- sure. An audible tone will sound for the entire time x-rays are produced. ‘The exposure duration is controlled by the following normal conditions: + The X-ray exposure switches must be held continuously ‘+ By the microprocessor pre-set back up time + By an independent “safety” hardware back-up-timer + By detection of a generator fault The radiation shield provides a minimum of 0.5 mm of lead equivalent attenuation at 35 kV. 5.5 Emergency OFF Switch There are two Emergency OFF Switches on the Gantry, and one on the Operator Console. Pressing any Emergency OFF Switch causes immediate shut down of the unit (see Figure 1-3 “ND. To resume operation after engaging an Emergency OFF Switch, turn the switch 1/4-turn to reset (see Figure 1-3 “B”), then press the Power ON button. Emergency Off Switch (typical) Chopter 1: IntroductionCe)o-FFVole MV EVE) 5.6 Interlock System In addition to the Emergency OFF Switch just mentioned, the M-IV has other inter- locks that prevent the unit from initiating an x-ray exposure unless: * The cassette is installed with Bucky use. + The room door interlock is closed. + The x-ray exposure foot-switch interlock is closed (NYC requirement). + Two X-ray switches are activated simultaneously ‘These interlocks and conditions are described below. 5.6.1 The Cassette interlock ‘The cassette interlock prevents exposure when the detection circuitry senses either of the following conditions: + Absence of a cassette in a Bucky Device * Failure to remove previously exposed film/cassette from the Bucky Device 5.6.2 The X-ray Switch Interlock The x-ray exposure switch must be activated for the entire duration of the exposure. must be released before the initiation of another exposure may occur. 5.6.3 The Early Release Interlock Releasing one or both of the X-ray switches, prior to the end of the exposure, imme- diately terminates the exposure. 5.6.4 The Automatic Compression Release Interlock Installing the Localization Paddle automatically disables the motorized compression release function. 5.6.5 Tho Image Receptor Support Device Interlock ‘The image receptor support device interlock prevents all C-arm movement and x-ray release when IRSD is removed (stereotactic configurations only). 5.6.6 The Compression interlock ‘The compression interlock prevents C-arm movement (up, down, rotation) whenever the compression force reading is 13 pounds or more. Chapter 1: IntroductionM- IV S Nene 6.0 Compliance Requirements ‘The following section details the M-lV compliance requirements and the manufacturer's responsibilities 6.1 Responsibility Statement LORAD is responsible forthe effects of safety, reliability and performance of this equipment with the following provisions: © The electrical i tallation of the com complies with the appropriate requirements ‘+ The equipment is used in accordance with instructions for use. ‘+ Assembly operations, extensions, readjustments, modifications, or repairs are performed by authorized persons only. 6.2 Compliance Statement ‘The manufacturer of tl time of manufacture: device complied with the following requirements applicable at the * 180 9007 = 15013485 = EN 46001 + FDA Quality System Regulation (QSR), 21 CFR 820 > ‘The system is designed, tested, and classified to comply with the following requirements: = IEC 601-1 = IC 601-2-7 © IEC 601-2-32 © IEC 601-1-2 + tC 601-228 + HEC 601-2-45 + EMC Directive + Medical Device Directive + UL2601 + CSA-C22.2 No, 601.1 +21 CFR Subchapter | 8 CChopter 1: IntroductionM-IV ar 6.3 Label Locations Compliance labels and nameplates are located as shown in Figure 1-4. Nameplates contain the unit's serial number and manufacturing date. MAGNIFICATION TABLE ‘CONSOLE Errcuncse Note; Labels are not to scalo| LABEL 6 LABEL cE Ee: LaseLe LABEL 2: Certiied Component LABEL 3: ULCompllance IMPORTANT | When replacing a certified component that Is concealed by a surlaca (le,, caver, panel, ate), the component's duplicate label on the exterior of the unit MUST BE replaced at the timo of service. IMPORTANT | When replacing a surface (i.e., cover, panel, etc. that has a certified component duplicate label(s), 4 label(s) that represents the certified component label(s) MUST BE placed on the new surface at the time of service. Figure 1-4: Label Locations Chapter 1: Introduction 9Note...Auto-Filter exposure mode is not available for magnification studies. A special note about 200 mrad requirements. Various states, foreign countries, and individual sites have instituted the 2 mGy (200 mrad) maximum average glandular dose requirement. Sites which must meet the 200 ‘mrad maximum average glandular dose requirement (due to either regulations or site preference) will only be able to operate using the Auto Window option. Sites not required to meet the 200 mrad maximum average glandular dase requirement ‘may choose to have the unit set so the Auto Window option is not available. These sites will only be able to select one of the Manual Timing windows. Sites not required to meet the 200 mrad maximum average glandular dose may choose to have the unit set to provide users with the option of selecting either the Auto Win- dow or Manual Timing windows. This feature must be enabled or disabled by a service engineer. The 200 mrad window is most effective when the screen-film speed is 170 or less. It is generally not necessary to use the 200 mrad window when the screen-film speed is {greater than 170. Please consult your Medical Physicist regarding screen-film combina- tions and the 200 mrad window for specific recommendations. Chapter 1: Introduction(e)o1Te Vole VEU T|) M-IV a Chapter 2: Accessory Set Up and Installation 1.0 Power and Data Connections When the M-IV is initially installed, all of the necessary Operator Console-to-Gantry cabling is completed by an authorized service representa- tive. Therefore, operator action {is not required regarding cable connections, The MV Gantry receives AC line power from an appropriately fused “disconnect” box. The Gantry then provides power for all unit subsystems, the Operator Console, and all accessories. The following checks are recom- mended prior to start-up, + Check that the circuit breaker (Figure 2-1), located con the back of the Gantry, is ON. + Check that all three Emer- gency OFF Switches, (2 on the Gantry, 1 on the Con- sole}, are reset. See “Emer- gency OFF Switch” on page 6. Figure 2-1: Power Configuration Chopter 2: Accessory Set Up and Insallaion uM = IV eno etel 2.0 Power Up Sequence ‘The following paragraphs describe the start-up sequence, including the pre- and post-power up checks 2.1 Pre-Power Up Checks Before applying power to the system, perform the pre-start-up checks below. Correct ALL discrepancies before applying power. + Check the unit (Console and Gantry} for open panels, loose or missing hardware. + Check for damaged or disconnected cables, and for other visible problems. + Verify the integrity of the radiation shield (chips, cracks, breaks). 2.2 System Power Up ‘Alter completing the pre-power up checks, perform the steps below to power up the system, + Switch the Input Power Circuit Breaker on the rear of the Gantry to the ON position. + Press the Power ON switch on the operator console. ‘iter pressing the power ON switch, a tone will sound and the operator console display will illuminate, indicating that the system is turned on and is powering up. ‘The Operator Console display will briefly show the message: “"The M-IV is performing start-up diagnostics” ‘The M-1V will perform a series of internal checks to verify that all subsystems are functioning properly. During this time, the remote micro-controllers activate, and display their version numbers near the bottom of the screen, I, during the diagnostic checks, the system detects a fault or an error condition, a message will display in the Message Area. To temporarily stop the start-up sequence so that the error ‘message remains on the screen, simultancously press the Shift and View keys. To resume the start-up sequence, press the Shift and View keys again. When the diagnostics are complete, the Display will show the system operational mode screen (Run Mode screen). 2.3 Post-Power Up Checks Perform the following checks after powering up the M4V Mammography System + Verify that all the C-arm Controls function properly. + Check that the Tubehead Controls function properly. + Verify operation of the operator console keyboard and switches. ‘+ Install a loppy disk in the floppy disk drive (for post-exposure data storage). 12 Chapter 2: Accessory Set Up and InstllationMI - IV _ Operator's Manual 3.0 The Image Receptor Support Device The Image Receptor Support Device (IRSD) (Figure 2-2), on the M-IV C-arm, accepts stan- dard screen-film image receptors and the HTC Bucky. ‘The Image Receptor Support Device houses: ‘+ the 7-position AEC detector + the Image Receptor Detector * the Image Receptor Micro- processor + the Bucky Driver Board + the Bucky Device connec- tion (On the back of the IRSD is a rocker-type switch that permits arm rotation (Figure 2-2, tem 1), Note that this switch func- tions identically to the C-arm Rotation Switches on either side of the tubehead. Figure 2-2: The Image Receptor Support Device ‘The IRSD has internal detection circuitry that senses the installed image receptor holder and automatically + Changes the collimator field size to the appropriate size for the installed image receptor. + Changes the Run Screen Receptor status line as appropriate for the type and size of the installed device. Chapter 2: Accessory Se! Up and Installation 13M-IV Ce)ol-tre\olp 4.0 The Bucky Device ‘The M-1V Bucky devices accept DIN-style cassettes only. These cassettes have a sliding window for photographic placement of exposure information directly onto the film using the integrated AutoFilm 10, ‘wo indicator lights (amber and green) are on the top surface of each Bucky device to alert the user to the presence or absence of a cassette, and to indi- cate exposure status. The following explains both indicators: GREEN - Ready status: cassette installed, film not exposed AMBER - Standby status: cassette absent, or |= film exposed Figure 2-3: Mounting and Loading a Bucky Device Installing and removing the Bucky Device To install a Bucky device, follow these steps: + Stand in front ofthe unit, facing the C-arm, + Align the side rails on the bottom of the Bucky device with the edges of the IRSD. ‘+ Slide the Bucky device onto the IRSD until it saps into place (Figure 2-3, direction *A’). To remove a Bucky device * Pull the Bucky Release lever on right side of the device, back to unlock (Figure 2-3, Item 1, direction *C"). + Slide the device off the IRSD. Loading and unloading the Bucky Device ‘To load a cassette into the Bucky device, follow these steps: *+ Position a cassette next to the cassette slot on either side of the Bucky device. *+ Slide the cassette into the slot until it snaps into place (Figure 2-3, direction *B") Removing a cassette from the Bucky: ‘+ Pusha Cassette Eject lever on either side of the Bucky (Figure 2-3, Item 2, direction “D") until the cassette slips out the cassette slot + Pall the cassette straight out of the Bucky. Chapter 2: Accessory Set Up and InstallationM-IV aE Operator's Manual 5.0 The Magnification Table For magnification studies, use the carbon-fiber Magnification Table (Figure 2-4). The Magni fication Table is complete with a built-in image receptor holder which is equivalent to a side- loading cassette holder. The Magnification Table slides onto the IRSD in the same manner as the Bucky device. 5.1 Installing the Magnification Table To install the Magnification Table, follow these steps: ‘+ Stand in front of the unit facing the C- arm. ‘+ Align the side rails on the bottom of the Magnification Table with the edges of the RSD. ‘+ Slide the Magnification Table onto the IRSD until it snaps into place. ‘To remove a Magnification Table: ‘+ Pull the release lever on the right side of the device, back to unlock. + Firmly hold both sides of the device. + Pull the Magnification Table straight off the IRSD. Figure 2-4: Installing the Magnification Table When installed, the detection circuitry automatically recognizes the Magnification Table, ‘The system then selects the small focal spot, and sets the collimator to the 18 cm x 24 cm field size (Manual Collimation), or to the size of the installed paddle (Automatic Collima- tion). 5.2 Loading the Magnification Table ‘To load a cassette into the Magnification Table, follow these steps: + Position the cassette at either side of the Magnification Table - next to the cassette slot. + Push the cassette firmly into the opening until it snaps into place. To remove a cassette from the Magnification Table: + Push a Cassette Eject lever on either side of the Magni slips out the cassette slot. + Pull the cassette straight out of the device. ‘The cassette holder portion of the Magnification Table has two indicator lights (green and amber) to alert the user to the presence or absence of a cassette. Exposures will nat be pro- hibited if the amber light is on. ation Table until the cassette Chopter 2: Accessory Set Up and Installation 156.0 Compression Paddles Manual ‘The M-IV uses several types of Compression Paddles in order to perform a wide range of mammography examinations. The following illustrations can serve as a guide for selecting ‘Compression Paddles for typical clinical applications. Legend for Figure 2-5: ‘Compression Paddle 24 x 30 Compression Paddle 18 x 24 FAS.T. Paddle 24 x 30 FAS. Paddle 18 x24 15 cm Contact Paddle 10 cm Contact Paddle 15 cm Magnification Paddle 10 cm Magnification Paddle 15 cm Perforated Local Paddle 10. 12. 13, 14. 15. 16. Vv. Figure 2-5: M-IV Compression Paddles 10 cm Perforated Local Paddle 15 cm Rectangular OPEN Paddle 10 cm Rectangular Local Paddle Frameless Spot Paddle 15 em Ultrasound Paddle ‘Small Breast Paddle 7.5 em Spot Magnification Paddle 7.5 cm Contact Spot Paddle CChopler 2: Accessory Sel Up ond InstallationFA.S.T. Paddle Selection Guidelines F.A.S.T. Paddle Use Use of the Fully Automatic Seli-adjusting Tilt (FA.S.T) paddle is very desirable for patients with breast tissue ‘compositions that do not permit uniform compression across the entire breast when using the conventional flat compression paddles. For these patients, inadequate compression across the entire breast area will result in an image that might appear to be “out of focus,” or “fuzzy,” in the anterior region. This is due to both invol- Uuntary motion as well as inadequate compression of overlapping tissue. For those patients witha disproportionate thickness at the chest wall compared to the anterior area of the breast, the FA... paddle will afford the following benefits: + Reduced motion artifacts due to better immobilization + More uniform compression from the chest wall to the nipple for superior image quality + Maximize patient comfort by preventing over compression at the chest wall ‘The FAST, Paddle is designed to automatically tilt as compression is applied. The paddle isin a flat position Until a compression force of approximately 20 pounds (88 Newtons) is applied, then it proceeds to tlt to its ‘maximum angle at an applied force of approximately 30 pounds (132 Newtons) or greater. Itis very impor- tant to apply sufficient compression pressure to immobilize the breast, however, the use of the F.A.S.T. Paddle does not require excessive compression for superior image quality. itis very important to be consistent in the application of compression using the FA.S.T. Paddle. Ths is partic- tlarly true for corresponding right and let views as ths will improve image quali ‘The FAS.T. Paddle may not be ideal for breasts that are equal or symmetrical in thickness from the chest wall to the anterior area of the breast. For operation with the HTC Bucky, proper compression is necessary when using the FA.S.T. Paddle. Excessive ‘compression may result in less than an optimum imaging technique selection when in one of the Auto-AEC modes. Compression Paddle Installation and Removal Procedures for installing and using the paddle for each breast type are described as follows, Installation 1. Align the mounting pins on the rear paddle from with the mounting holes in the Compression Device. 2. Push the paddle firmly into the Compression Device until it stops 3. Gently pull the paddle out until it clicks into place. (This sets the detents of the mounting pins.) Removal 4, Place a hand on either side of the Compression Paddle frame. 5. Pall the Compression paddle straight out of the mounting holes by grasping the metal frame. Monulacured by LORAD, A Hologic Company® PN 9.600.0099, Revision | 36 Apple Ridge Road, Donbury, CT 06810 |203]207-4500i Operator's Manual AEC Sensor Markings ‘The transparent surfaces of the 18 x 24 cm and 24 x 30 cm Compression Paddles are marked with the detent positions of the AEC Sensor to help the user accurately position the AEC Detector during automatic-mode exposures. Mounting and Removing the Compression Paddles All Compression Paddles mount to, and are removed from, the Compression Device in the same manne To mount the Compression Paddle: + Align the mounting pins on the rear paddle frame with the mounting holes in the Compres- sion Device. + Push the padille firmly into the Compression Device—until it stops. + Gently pull the paddle out to properly set the detents of the pins. Figure 2-6: installing Compression Paddles ‘To remove the Compression Paddle: + Place a hand on either side of the Compression Paddle frame, + Pull the Compression Paddle straight out of the mounting holes by grasping the metal frame. AX Neier Removing the compression paddle by grasping the plastic may cause damage to the plast A detector within the Compression Device senses the presence and type of Compression Paddle installed. This causes the system to do one of the following: ‘+ Automatic collimation mode: Move the automatic collimator to the appropriate field size for the installed compression paddle. + Manual collimation mode: Move the automatic collimator to the approp for the installed Image Receptor. fe field size ‘When the installed Compression Pacdle is a Localization Paddle, the detection circuitry also switches the Compression Release mode to LOCKED-OUT. Chapter 2: Accessory Se! Up ond Installation 77.0 Radiation Shielding azul 72 73 Ax, Noten. The face shield doesnot offer protection from exposure through the arylic, ‘The unit provides shielding devices to protect the patient and operator {rom exposure to radi- ation. ALWAYS ensure that the shielding devices are attached, and remember to check their condition prior to use each day. The Patient Face Shield ‘The face shield (Figure 2-7) prevents the patient's head and face from entering the x-ray field during the examination, The face shield mounts to the tubehead and surrounds the x-ray tube port. To install the face shield, follow these steps: * Slide the open end of the face shield into the slots on the tubehead mount. + Push the face shield com- pletely on the mount until the rear tabs snap in place. To remove the face shield, follow these steps: + Spread the rear tabs apart slightly + Pull the shield straight off the mount. Figure 2-7: Installing the Face Shield ‘but is provided to prevent the patient’ head and face from entering the x-ray feld. The Operator Shield ‘The operator shield, which is permanently mounted to the rear of the Operator Console, pro- tects the operator from exposure during the procedure. Note that the height and width ofthe ‘Operator Shield allows an unobstructed view of the patient during the examination. The M-IV Mobile unit does not come with an operator shield. Shielding will be provided and installed by the M-IV Mobile installer at time of system installation Other Shielding The following shielding, inherent in the design of the system, prevents exposure to unwanted scattered or direct radiation: + The Image Receptor Support Device prevents x-ray penetration below the breast tray. +The tubehead fining absorbs all x-adiation except for the beam that penetrates through the tube por. 18 Choplor 2: Accessory Sot Up and Installation8.0 Dual Function Footswitches A, ‘The M-IV incorporates two footswitches that control C-arm Up/Down mavement and Com- pression Up/Down movement. These footswitches free the operator's hands for patient and breast positioning Both pedals operate identically, and are clearly labeled! + ARM UP and DOWN + COMPRESSION UP and DOWN ‘The footswitches plug into receptacles inside the Gantry (near the bottom), and are con- nected by a service engineer at installation. These receptacles are not user accessible, Place each footswitch on the floor so that one is accessible from the left side of the C-arm, and the other is accessible from the right side, WARNING! Always position the footswitches so as to eliminate accidental activation by patient, operators, or wheelchairs. 8.1 Operating the Footswitches To use the footswitches, follow these steps: + Step on the pedal labeled C-ARM UP to raise the C-arm, Release the switch to stop movement (Figure 2-8, A). + Step on the pedal labeled C-ARM DOWN to lower the C-arm, Release the switch to stop movement (Figure 2-8, A). ‘+ Step on the pedal labeled COMPRESSION UP to raise the compression device. Release the switch to stop movement (Figure 2-8, 8). ‘+ Step on the pedal labeled COMPRESSION DOWN to lower the compression device. Release the switch to stop movement (Figure 2-8, B). Figure 2-8: The Dual Function Footswitch The footswitches provide the same movement control as the push-button controls on the C- arm and enables the same M-1V functions: * The light field lamp illuminates upon Compression Down, * LOCKOUT mode disables the motorized Compression Release push-buttons. Chopler 2: Accessory Set Up end installation 19M-V Operator's Manual 9.0 Film Labeling 91 92 The system provides identification and technique factor labeling on mammograms by means of the integrated AutoFilm ID unit, or the optional label printer. The Autofilm ID “flashes” a photographic image of patient demographics and the exposure factors onto the film before it isdeveloped, while the printer provides a hard copy label for placement onto the film after it is developed. The AutoFilm ID 91. The Auto Film ID is a photographic labeling unit that eliminates the need to manually label the mammogram. This unit is integrated into the Operator Console and requires the use of DIN-style cassettes. The Autofilm ID must be selected ON prior to operation. Alter an exposure, the Autofilm ID will sound a tone to remind the user to “flash” the film, Tone will continue until the cassette is inserted into the AutoFilm ID. The last exposure data can be sent to the Auto-ID again when a dot {¢1 is displayed next to the Auto-ID field in the right status column of the Run screen This may be used if the Auto: 1D was canceled and the information is still required. Remember, only the last exposure information is accessible so if another exposure is made, any previous data is no longer available, When the Clear key is pressed, this dot [e] is no longer displayed and the last exposure information is no longer available. 1. Using the AutoFitm ID To place the photographic label onto the film using the AutoFilm ID, perform the following: + Remove the cassette from the image receptor after the exposure + Position the cassette in front of the ‘AutoFilm 1D cassette slot (Figure 2- 9,41). + Orient the cassette so that it faces up and the “window” isto the right (Figure 2-9, #2). + Slide the film cassette into the AutoFilm ID unit. Make sure the right side of the cassette remains against the right wall of the slot during insertion (Figure 2-9, #3). A continuous tone will sound while the Autofilm ID unit “lashes” the film ‘+ When the tone stops, pull the cas- selte straight out of the assembly. Figure 2-9: Inserting the Cassette into the AutoFilm 1D The Label Printer (optional) The optional printer provides a hard copy label for manual attachment to the mammogram When the printer is installed, it must be turned ON, and selected in the Setup Mode before a label will print. Labels are automatically printed at the completion of an exposure. 20 Chapter 2: Accessory Se Up ond InstallationM-IV 10.0 Optional Equipment ‘Optional equipment, such as the LORAD DSM, the LORAD StercoLoc 1! Biopsy System, and the HIS/RIS System install easily. The following section provides setup information for the ‘optional equipment available for use with the system. For detailed instructions, refer to the ‘Operator's Manual for each option. 10.1 The LORAD StereoLoc II Biopsy System The StereoLoc Ils an option that configures the M-IV for stereotactic procedures. The Stere- ‘oLo¢ Il Biopsy System consists of 4 major assemblies: ‘+ the Stage/Biopsy Assembly ‘+ the Internal Rotation Brake Assembly + the Control Module * Stereotoc IRSD The Rotation Collar is installed at the factory (on sales order), or in the field by a LORAD ser- vice representative. The Stage/Biopsy Assembly, Control Module, and the IRSD are installed ‘onto the C-arm a5 necessary for the apy ‘The StereoLoc Il operates with standard screen-film combinations, or with the LORAD DSM System. 10.2 The LORAD DSM The DSM option provides digital, near real-time imaging for needile placement procedures ‘when itis used in conjunction with the LORAD StereoLoc Il Breast Biopsy Device. The DSM. ‘System is factory-configured for use and installed at location by a LORAD service represen- tative. CChoptor 2: Accessory Se! Up and Installation 2Operator's Manual 22 Chapter 2: Accessory Se! Up end InsialltionM-IV [= Chapter 3: System Controls 1.0 Operator Console Controls ‘The operator console, on the Operator Console, is used to enter exam information via the Alphanumeric keys, the Function keys, and the View keys, and to set the exposure tech- niques for the examination using the Exposure Technique keys. ‘The operator console contains the following: X-ray Exposure keys (2) Compression Release key Power ON and OFF buttons Function Keypad Alphanumeric Keypad View Keypad Exposure Technique Keypad Sterealoc Il Option Keys (Stereo and C-Arm Position, not present on units without LORAD Stereoloc Il option) In addition to the controls listed, an Emergency OFF Switch is positioned on the left side of the Operator Console frame which, when pressed, immediately removes power from the sys- tem. PNOWA eR ‘A Bar Code Reader (option), located to the right of the operator console, provides an alter- nate means of entering patient data The paragraphs that follow describe the various components of the operator console. Figure 3-1: The operator console Chopter 3: System Controls 29Operator's Manual 1.1 The Alphanumeric Keypad ‘The Alphanumeric keyboard is a subset of a standard “computer” style keyboard. Some key caps will differ depending on the country (language) the keyboard supports. Use this key- board in the Run Mode to: + Enter patient and technologist identification data. ‘+ Manually input a CPT Code. ‘+ Type comments pertaining to the patient or exam. In the Additional Setup Mode, use these keys to: ‘+ Make time and date changes. * Enter screen-film types for c ‘+ Type site the name and address information. & ‘The Alphanumeric Keypad has three command keys: Shift, Ctrl, All, of which, only Shift is operational. Pressing Shift alone switches between upper and lower case letters; pressing Shift + Clear together cancels the AutoFilm ID function. LR Noltvette the CAP LOCKS key to ewitch between upper and lowercase type. When CAP LOCKS is on, the label “CAPS” appears in the upper right corner of the Run Mode screen, 24 Chapter 3: Systom ControlsM- IV ; Operator’ 1.2 The View Keypad ‘The Mammography View keys, the Run/Setup key, the Change key, the Clear key, and the Reset key compose the View Keypad. Use these keys to perform the following: + Switch between the Run Mode and the Setup Mode (Run/Setup) ‘+ Switch among the data field choices (Change) + Erase data field entries (Clear) + Select clinical view labels (View keys) + Acknowledge error messages (Reset) The following paragraphs describes the functions of each View Keypad component in more detail. Figure 3-2 shows the entire View Keypad. = 2B || oot E 7 wi ||| nei] & i a im ||| cir) |||aux| Figure 3-2: The View Keypad CChoptor 3: Systom Controls 25M-IV a Operator's Manual 1.2. 1.2 1.2; 1. The Run/Setup Key & Press this key to toggle between the Run Mode screen and the Setup Mode screen. In the Run Mode, perform the following to switch screens: + Press the Runy/Setup Key to access the Setup Mode screen. * Press the Run/Setup Key again to return to the Run Mode screen, 2 The Change Key ‘When the highlight bar is on a data field which contains multiple choices, pressing Change toggles through the available options for that field. Access the Setup Mode screen and per- form the following example which illustrates using Change: + Move the highlight bar to the Compression Release data field using the Arrow Keys. ‘Press Change several times to cycle through the choices: AUTOMATIC or MANUAL. «The selection that appears in the data field is the current mode (option) for that machine function, 3 The Clear Key Press Clear on the View Keypad and observe the following occurrences: * Deletes the entry for the Patient ID and Patient Name, * Clears the data in the Birth Date, CPT Code, and Comments data fields ‘+ Automatically moves the highlight bar to the Patient ID data field. ‘+ Sets ALL exposure techniques to the defaults. ‘Note that the Tech ID data line is only cleared when the Additional Setup data field “Tech 1D cleared with Clear Key" is set to YES. 1.2.4 The Reset Key i This key permits the user to acknowledge an error message. To use this key, do the follow- ing: + Take the appropriate action to reset the error or fault condition indicated in the mes- sage! + Press the Reset key to clear the message. * Verity that the system status returns to normal operational mode (READY) 26 Chapter 3: System Controls >»M- IV 2 Operator's Manual 1.2.5 Mammography View Keys Mammography view labels are on eleven of the keys that comprise the View Keypad. These keys permit the user to manually select a clinical view label for the mammography examina- tion, This label will appear in the Run Mode VIEW data field. Below are the eight most common mammography views, which are selectable by a single key: dé Left Craniocaudal || Right Craniocaudal ey he Left Mediolateral a Right Mediolateral — ws Es Left Lateromedial ee Right Laterom Ys ay Imiol] Left Mediolateral Oblique Bol] Right Mediolateral Oblique ey Van To add “roll” view positioning as a suffix to the views (e.g,, LCC RL is a Left Craniocaudal upper breast tissue Rolled Laterally), press... AUX 10 switch among the following: RL Rolled Lateral RM Rolled Medial 1D Implant Displaced Ifthe AUX key is pressed alone, PHANTOM will appear in the view field. This is for labeling, of the mammography phantom. Keep in mind that for phantom to appear, this key must be pushed without a view in the view field. Othenwise, this key acts as a suffix with RL, RM, or 10, Chapter 3: System Controls 27M-IV ‘To choose views other than the eight common views, first select the lateral prefix... Va 3 Operator's Manual Left Right then select the clinical view by pressing the AUX key to switch among the following: 10 S10 Mo, FB TAN at wv xecl Implant Displaced Superolateral to Inferomedial Oblique Lateromedial Oblique From Below Tangential Axillary Tail Cleavage Exaggerated Craniocaudal Press Enter to complete the clinical view selection. Note that the letter "MM" appears after the lateral designation whenever the magnification table is on the image receptor support device {ie., RM MLO isa Right Magnification Mediolateral Oblique view). & examples of entering exam views. 1.3 The Exposure Technique Keypad Use the Exposure Technique keypad, above the alphanumeric keys, to set the exposure parameters for the examination (see Figure 3-3). ‘The descriptions below detail the functions of each Exposure Technique key or key set. EoEae Figure 3-3: The Exposure Technique Keypad 28 CChopter 3: System Controls »WV VATE 1.3.1 The Mode Select Key ‘The Mode Select Key permits the user to select the exposure mode for the examination. The system runs in one of three automatic modes, or a manual mode is available for user selec- tion of all factors. ‘The four exposure modes are: + Manual = Auto Time © Auto-kV = Auto-Filter To select an exposure mode, perform the following: * Enter the Run Mode. + Press Mode Select several times to cycle through the available exposure modes, + Release the key when the preferred exposure mode is shown in the data field LX Nole.-All exponure modes are avaiable for magnifiatianstues except Auo-Flter Installing the Magnification Table changes the Mode field label to read “mag”. 1.3.2 The filter Select Key Use Filler Select to choose the desired filter for the exposure. The available filter choices are: + Mo (Molybdenum) + Rh (Rhodium) To select a filter for the exposure perform the following: * Enter the Run Mode and select the desired exposure mode (Manual, Auto-Time, Auto- kv). + Press Filter Select to switch between the two choices: Mo or Rh. + Release the key when the preferred filter choice is shown in the data field. 1.3.3 The kV Set Keys Use this 2-key pair to increase or decrease the exposure kV level in the Manual or Auto-Time exposure modes. ‘The following steps detail the use of the kV Set Keys: ‘Enter the Run Mode and select either Manual or Auto-Time exposure Mode. ‘+ Press the up arrow key to increase the KV level by 1 kV (up to 35 KV for Mo filter, or 39 KY for Rh filter), ‘+ Press the down arrow key to decrease the kV level by 1 kV (to 20 kV for Mo filter, of 28 KY for Rh filter). Chapter 3: System Controls 29M-IV (e}el=}e-\oyeeM YE Ultre 1.3.4 The mAs Set Keys Use this 2-key pair to increase or decrease the exposure mAs for Manual mode exposures. ‘The selectable mAs range is between 3 mAs and 500 mAs, with each increment change ‘dependent upon the selected mAs mode (Table 1 or Table 2) selected in the Setup Mode. Refer to “Automatic Exposure Control (AEC)" on page A-109 for more information. ‘To sel the mAs for the exposure: ‘+ Enter the Run Mode and select Manual exposure mode, + Press the up arrow key to increase the mAs level (up to 500 mAs). + Press the down arrow key to decrease the mAs level to 3 mAs). 1.3.5 The Density Set Keys Use this 2-key pait, which is available in all exposure modes except Manual, to increase oF decrease the density setting for the exposure. The Density feature is used to compensate for daily variations in film processors. For additional information, refer to “Chapter 1: introduc tion’, “Automatic Exposure Control (AEC)" on page A-109. ‘To change the Density setting, perform the following: + Enter the Run Mode and select any exposure mode except Manual mode. * Press the up arrow key to increase the density setting by one digit. + Press the down arrow key to decrease the density setting by one digit. 1.3.6 The Focal Spot Select Key ‘The M-IV offers a choice of two focal spot sizes to accommodate various applications: a 0.3 ‘mm Large focal spot, and a 0.1 mm Small focal spot. The focal spot size is selectable in ‘Manual, Auto-Time, and Auto-kV modes. To switch between the two choices, perform the following: + Enter the Run Mode. * Press Focal Spot Select to switch between the two choices. 1.3.7 The Film Select Key aw This key permits the user to select the screen-film combination being used for the exam. The choices available here will depend upon the entries made in the Service Setup Mode (Chap- ter). To select the screen-film combination, do the following: * Enter the Run Mode, + Press Film Select to cycle through the available choices. + Release the key when the preferred film label appears in the data field Note...Film types shown on the screen are labels only. Until they are calibrated by a service engineer, for both the molybdenum and hodiumn filters, the proper densities are not set for the film type used. 30 Chapter 3: System ControlsMI-IV é 1.4 The Function Keypad ‘The ten keys on the left side of the operator console comprise the Function Keypad (Figure 3- 4). Operator's Manual ‘The following subparagraphs describe each key of the Function Keypad: ‘The CPT Code Key ‘The Stereo Key The C-arm Position Key ‘The Cursor Keys (arrows) ‘The View Key The Display Contrast Key Collimator Lamp Figure 3-4: The Function Keys Chopter 3: System Contole 31M - IV a (e)ol=trViolg QA Netesiteber the Sterotne ¥ doczmentaton far etait operational intrctions 1.4.1. The CPT Code Key Use this key to scroll through the scheduled exam billing codes for that patient. The avail- able choices will appear in the CPT Code data field in the Run Mode. Below are the steps necessary to schedule CPT Codes for a patient. ‘+ While in the Run Mode, highlight the CPT Code data field ‘+ Press Change to scroll through the preset list of billing codes. + When the desired billing code appears, press Enter to schedule the patient for the exam. When scrolling through the CPT Code list using Change, the billing codes appear dir (half- bright). When a CPT Code is scheduled by pressing Enter, the billing codes appear bright. ‘To switch between the scheduled CPT Codes for that patient, press CPT Code several times to scroll through the scheduled billing codes for that patient. Upon selection of a CPT Code, the associated exam views are automatically placed in the Exam View data field. However, manually entering a CPT Code will require that the exam view also be manually entered using the mammography view keys 1.4.2. The View Key Use this key to cycle through the available mammography views for the selected CPT Code. The available choices will appear in the Exam View data field in the Run Made. Perform the following to select a pre-associated exam view: ‘+ While in the Run Mode, select a billing code by pressing CPT Code. + Press View repeatedly to select among the available exam views. AK, Nlate-lt isnot necessary to move the highlight int the CPT Code data eld to use the View key. 1.4.3 The Slereo Key This key is only functional when the M-IV has been configured for stereotactic use, and when the LORAD StereoLoc il device has been mounted onto the C-arm. Use this key to set the M-IV so that the C-arm only rotates to the stereotactic projection angles (C-arm shifts £15° while the StereoLoc II remains stationary}: + Install the StereoLoc Il device on the M-IV C-arm. The system automatically is set for ste- reotactic mode. (Follow the steps outlined in the StereoLoc ll Operator's Manual.) + Press C-arm Position to set the system for needle approach, + Position the patient, compress the breast, then press Stereo to set the system back to ste- reotactic mode. 32 CChopier 3: System ControlsM-IV 2 : (e)el-ieetole ow eUrere 1.4.4 The C-arm Position Key 15 & This key is only functional when the MV has been configured for stereotactic use, and when the LORAD Stereotoc 1! device has been mounted onto the C-arm. Use this key after a stereotactic procedure to set the M-IV C-arm for normal rotation (C-arm and StereoLoc II rotate together + Alter the stereotactic procedure, rotate the arm to the Needle Approach Angle (Stereo Zero). ‘+ Press C-arm Position to set the system for normal C-arm rotation. Note...Refer to the StereoLoc I documentation for detailed operational instructions. 1.45 The Cursor Keys Use this 4-key set, identified by their arrow labels, to move the highlight bar through the selectable on screen data fields. Each arrow key (Cursor) moves the highlight bar in the direction indicated by the label on the key cap, one data field ata time. Below details this movement: Up Arrow: highlight moves ftom bottom to top Down Arrow: highlight moves from top to bottom Left Arrow: highlight moves from right to left Right Arrow: highlight moves from left to right 1.4.6 The Display Contrast Key 147 Col Each time the key is pressed and released, a small change in display contract is made. Repeatedly press-and-release this key to brighten or darken the display screen, ator Lamp Button This switch turns on the collimator lamp, which provides a visual representation of the x-ray field, Use this feature as necessary to accurately position the patient in the x-ray field. The collimator lamp illuminates for approximately 30 seconds whenever this switch is pressed, and it extinguishes automatically. Other Console Controls The Operator Console also provides additional controls, as described below, 1.5.1 Power ON/OFF Buttons Use this button to turn the machine ON or OFF. Note that prior to applying power, it is rec- ‘ommended that the user perform the pre-power up checks detailed in “Chapter 2: Accessory Set Up and installation’, "Pre-Power Up Checks” on page 12. To apply power, press ON; to shut the unit down, press OFF, Chapter 3: System Controls 33Operator's Manual 1.5.2 Compression Release Button ‘A Compression Release button on the right side of the operator console provides a means to quickly release the patient from compression, provided the Compression Release Mode is set to MANUAL. Refer to “Compression Specifications" on page A-104 for more information. The following is an example sequence for using the compression release button: * Inthe Setup Mode, change the Compression Release Mode to MANUAL. + Lower the Compression Device + Press Compression Release to release the compression brakes and raise the Compression Device. 1.5.3. X-ray Buttons ‘The Operator Console has two X-ray Buttons which are used simultaneously to initiate an exposure, One button is on the left side of the operator console; the other button is on the right side. When the M-IV status reads READY, perform the following to initiate exposure: + Step completely behind the radiation shield. * Check all exposure techniques and setup information for accuracy. + Press BOTH x-ray buttons simultaneously for the duration of the exposure - until the tone stops. A, WARNING! Observe all safety precautions when making x-ray exposures. Note that releasing either or both x-ray buttons before the exposure has ended (when the tone stops) will automatically terminate the exposure and cause the system to display an 1.5.4 Emergency OFF Switch On the left side of the Operator Console housing is one of the units three Emergency OFF switches. Pressing this switch immediately removes ALL system power. Refer to “Emergency (OFF Switch” on page 6 for additional information. To reset the machine after pressing this switch, perform the following: + Remedy the situation that precipitated pressing the Emergency OFF switch. * Rotate the mushroom-type switch 1/4-turn clockwise to reset. * Perform a standard start-up procedure, Chapter 3: System ControlsOperator's Manual 2.0 C-arm Controls There are identical push-buttons on either side of the C-arm that control the following opera- tions on the mammography system (see Figure 3-5): + arm Up and Down + Compression Up and Down + Compression Release Also, there is a rockertype button on the rear of the image receptor support device that con- trols: © arm rotation ‘Thore are also hand wheels on either side of the Compression Device for manual movement of this device. Use of each push-button and the hand wheels, is described next. Figure 3-5: C-arm Push-button Controls 2.1 C-arm Up and Down Controls ‘arm Up and C-arm Down buttons are on both C-arm button panels (one on either side of the C-arm), This set of buttons moves the C-arm up or down for height positioning of the image receptor support device. To move the C-arm up or down, perform the following: + Press and hold a C-arm Up button to raise the C-arm assembly; release the button to stop movement. + Press and hold C-arm Dn to lower the C-arm assembly; release the button to stop move- ment. Note that the C-arm will stop automatically upon reaching the upper or lower C-arm travel limits. The C-arm Up button is convex, and the C-arm Down button is concave. Chapter 3: System Controls 35Manual 2.1.1 Compression Up and Down Switch Compression Up and Down buttons are on both C-arm button panels (one on either side of the C-arm), Use these buttons to raise the compression device (increase thickness), or to lower the compression device (decrease thickness). ‘The Compression Up button is convex, and the Compression Down button is concave for tactile discernment, To move the Compression device, perform the following: + Press and hold Compression Up to raise the Compression Device. + Release the button to stop upward movement. + Press and hold Compression Down to lower the Compression Device and illuminate the light field lamp. + Release the button to stop downward movement Once 12 pounds of force is applied to an object, ALL C-arm movement controls (i.e, C-arm Up, C-arm Down, C-arm Rotation) are disabled The amount of compression force applied to an object depends upon the set compression ‘mode (Pre-compression or Full-range Compression), and the force setting of that compres- sion mode (10% to 100% the range). ‘Note that the compression device will stop automatically upon reaching the upper or lower Ls, Nlola-The Compression Up and Down functions are also availabe using the dua func- tion Footswitch. 2.1.2. Compression Release Button ‘A Compression Release button on both C-arm button pads provides quick release of the patient from compression, provided the Compression Release Mode is set to MANUAL. The function and use of this button is the same as the operator console Compression Release but- ton. The Compression Release button has a raised bump on its surface for identification by touch. ‘The M-1V has an AUTOMATIC Compression Release feature which, when pre-selected in the Setup Mode, releases compression automatically atthe end of each exposure. However, ifa Localization Compression Paddle is used, the system senses the paddle and “locks out” the ‘Automatic Compression Release function. 2.1.3. C-Arm Rotation Button Use this rocker-type switch on the rear of the IRSD to control C-arm rotation. One side of the switch is labeled for clockwise rotation, the other side for counterclackwise rotation. To rotate the C-arm to the angle necessary for the clinical view, perform the following: + Press and hold the clockwise label side of the switch to move the C-arm to a more posi- tive angle. + Release the switch to stop clockwise rotation. * Press and hold the counterclockwise label side of the switch to move the C-arm to a ‘more negative angle. ‘+ Release the switch to stop counterclockwise rotation. 36 Chapter 3: Systom ControlsM-IV ; eee 21 The rotation drive circuitry slowly ramps up the C-arm drive speed to provide a smooth tran- sition from stopped to full speed. As the C-arm approaches vertical, the rotation speed slowly decreases until the C-arm stops at 0°, before continuing. The C-arm angle appears on read ‘outs on either side of the Gantry. Note... The C-arm Rotation functions are also available using tubehead controls. ‘C-arm rotation function differs if your system is configured for stereotactic procedures, When the Stereol.oc I! is installed, pressing Stereo sets the system so that the C-arm rotates only to the stereotactic projection angles. Refer to the StereaL.oc Il documentation of detailed opera- tional instructions. .4 Manual Compression Handwheels ‘Manual compression Handwheels are provided to adjust the Compression Device manually (see Figure 3-6:*Manual Compression Handwheels”). Use these controls in addition to the motorized compression methods. The handwheels work as follows: + Rotate the handwheels in one direction to decrease object thickness (apply compres- sion). + Rotate the handwheels in the opposite direction to increase object thickness (release compression). ‘Moving the Compression Device manually permits the user to apply up to 67.4 Ib (300 N) of force (maximum) onto the object. This method of compression is used after applying motor- ized compression. ‘Note that motorized compression will engage a clutch mechanism in the Compression Device to prevent back-slip. The clutch allows the user to easily apply manual downward compression, while restricting manual upward compression. To override the clutch, use a motorized up method. Figure 3-6: Manual Compression Handwheels Chopter 3: Systom Controls 73.0 Compression Device Display The M-IV C-arm has separate readouts and indicators for the following functions (see Figure 37): + Compression thickness + Compression force ‘+ AEC Sensor Position Indicator Figure 3-7: Compression Device indicators 3.1 Compression Thickness Display ‘Two Compression Thickness displays (one on each side of the Compression Device cover) show the distance between the bottom of the Compression Paddle and the top surface of the image receptor holder. The readouts display the compression thickness in 0.1 cm incre- ‘ments between 0 cm and 15 cm. To see how the display functions, perform the following: ‘+ Press a Compression Up control to raise the Compression Device and observe the increase in the compression thickness readout. ‘+ Press a Compression Down control to lower the Compression Device and observe the decrease in the compression thickness readout. Note...The system senses the type of image receptor installed (Bucky, Magnification QS _ableetc) and compensates the thickness appropriately. 38 Chapter 3: Systom ControlsM-IV 3.2. Compression Force Display ‘Two Compression Force displays (one on each side of the Compression Device cover) show the approximate force being applied to the compressed object. The readout displays the compression force in either pounds (5 Ib to 67.4 Ib) or Newtons (20 N to 300 NJ, whichever is preset as the default in Setup. To see how the force readout works, perform the following: + Place an object (phantom, breast equivalent material, etc.) on the Image Receptor Sup- port Device, then install a Compression Paddle. Press a Compression Down control to compress the object between the Paddle and the Image Receptor, and observe the increase of the force readout. + Press a Compression Up control to lift the Paddle off the object, and observe the decrease of the force readout. 3.3. Automatic Exposure Control Sensor Position Indicator ‘A sensor in the Image Receptor Support Device measures the x-radiation that penetrates the breast during an exposure. The AEC sensor may be placed in one of seven detent positions. ‘Typically, the sensor is placed below the glandular tissue in the anterior region of the breast ‘To check the function of the two indicators (one on each side of the Compression Device coven, perform the following: * Install a large Compression Paddle. * Grasp the AEC Sensor handle beneath the IRSD and move it back and forth to all seven positions * Observe that the corresponding LED on the position display changes. Chapter 3: System Controls 394.0 Tubehead Controls ‘A.control pad on either side of the Tubehead contains identical buttons and switches for see Figure 3-8) + Carm Rotation + Collimator Override + Light Field Lamp The following paragraphs describe the use and functions of each of these buttons, Figure 3-8: Tubehead Button C-Arm Rotation Switch Use this rockertype switch, on either side of the tubchead, to control C-arm rotation. One side of the switch is labeled for clockwise rotation, the other side for counterclockwise rota- tion. This switch functions the same as the Rotation switch on the rear of the IRSD for both stan- dard mammography, and for stereotactic procedures (if applicable). 4.1.1 C-Arm Rotation Memory To help with patient positioning, the M-IV employs a C-arm Rotation Memory feature. After ‘making an oblique exposure, the C-arm angle is stored in memory. When the technologist rotates the C-arm past 0° for the next exposure, the rotation circuitry automatically stops the C-arm at the opposite oblique angle. The technologist may then rotate the C-arm to an angle other than the memorized oblique angle if necessary. Collimator Lamp Button This button turns on the collimator lamp, which provides a visual representation of the x-ray field. Use this feature as necessary to accurately position the patient in the x-ray field. The collimator lamp illuminates for approximately 30 seconds whenever this button is pressed, and it extinguishes automaticaly. 40 Chapler 3: Systom ControlsM - IV : Operator's Manual 43 Collimator Override Button The iniernal beam limiting device uses either an automatic mode or a manual mode to colli- mate the x-ray field appropriately for the installed Compression Paddle and Image Receptor. Choice of the collimator mode is made in Setup. The Collimator Override is used to change the automatically selected x-ray field size to a size other than that of the installed Compres- sion Peddlle (Automatic Mode) or the installed Image Receptor (Manual Mode). AUTOMATIC MODE: When Automatic collimation is set, the collimator adjusts to the field size ofthe installed Compression Paddle, or to the installed Image Receptor when no Paddle is atlached. The Collimator Override button allows changing the field size up to the size of the installed Image Receptor. Note that collimation averride will not allow field sizes any larger than the size of the attached Image Receptor. MANUAL MODE: When Manual collimation is set, the system detection circuitry senses only the size ofthe installed image receptor (cegardiess of the size of the installec| Compres- sion Paddle), and automatically limits the field size appropriately. All subsequent field size adjustments, all of which must be smaller than the size of the attached Image Receptor, are ‘made using the collimator override. In either mode, use the Collimator Override button to adjust the collimator blades for field sizes other than the preset field size: * Install the appropriate Image Receptor and Compression Paddle. + Press the Collimator Override button to illuminate the light field lamp and to adjust the collimator blades to one of the available field sizes, depending on the selected mode and installed accessories, Chopler 3: System Controls 4M-IV 5.0 Gantry Controls and Indicators ‘The Gantry contains the following user controls: ‘+ Two Emergency OFF Switches ‘+ Input Power Circuit Breaker 5.1 The Emergency OFF Switch The Gantry holds two of the system’ three Emergency OFF switches (one on either side door, see Figure 3-9), Pressing this immediately removes ALL system power. These switches work identically to the switch on the Control Console. Figure 3-9: The Emergency OFF Switch 5.2 The Input Power Circuit Breaker ‘The Input Power Circuit Breaker is located on the back of the Gantry. Typically, the circuit breaker is left ON. However, always check the circuit breaker status prior to applying power each day. 42 Chopter 3: System ControlsOperator's Manual 5.3. C-Amm Angle Display Le clsplays on both sides of the MV Gantry show the C-arm angle. These readouts change as the C-arm rotates: Rotate the C-arm clockwise and observe that the display changes to a more positive reading. Rotate the C-arm counterclockwise and note that the display changes to a more negative reading. Figure 3-10: C-arm Angle Display Chapter 3: System Controls 4a44 Chopter 3: System ControlsM-IV Operator's Manual Chapter 4: User Interface—The Run Mode 1.0 User Interface Overview Upon power up - before displaying the Run Mode - the system initially sequences through a series of internal checks to ensure all subsystems are ready for use. Upon successful comple- tion of these checks, the Run Mode screen appears and the system is ready for user interac- tion, The following paragraphs describe the components of the Start-up screen and the Run Mode screen The Start-up Screen The Start-up screen, which only appears during the power up sequence, displays start-up information such as diagnostics status and subsystem software versions. During the diagnos- tic routines, the main microprocessor performs the following: + sub-processor functional checks + displays status of sub-processors (faults, errors) + displays version of sub-processor softwaresfirmware If problems occur with any portion of the start-up routine, the system halts the start-up pro: cess and sends an appropriate error message to the display. After the user rectifies the error, the system repeats the test in the problem area, and upon successful completion of that test, continues the diagnostic routine. The Sta Lup Mode screen has three main section + the Setup Window + the Message Window * the Sub-system Reporting Win- dow ‘The Setup Window displays all start-up information, prompts, and error messages. User actions or responses appear in the larger (left) portion of the Message Window ‘while the operating condition ofthe unit displays in the smaller Status area (right portion of this window. Figure 4-1: The Start-up Mode Screen The Subsystem Reporting Window shows the software versions of the seven system sub-pro- Chopter 4: User Interfaco-The Run Mode 45M-IV 12 ieVole a UEUIE The Run Mode Screen When the MV completes the start-up sequence, the system automatically enters the Run Mode, which indicates that the system is ready to receive patient and exposure information. In the Run Mode, the user performs the following tasks: ‘+ Inputs patient information and exposure technique factors * Views accessory configuration + Reads system operational status messages (errors and help prompts) + Permits user access to the Setup Mode The Run Mode screen is divided into three sections: + the Setup Window + the Message Window + the Exposure Technique Window The Setup Window is the area of the screen in which the user enters patient identification information and exam data, and observes system accessory status. The Setup Window has ‘wo columns: an ID Column (left side) and a Status Column (right side). The ID Column contains patient and technologist identification information, exam codes and views, compression release mode, andl exam comments. The data fields in the ID Column require user input. The data fields in the Status Column only display machine or accessory status. The Status Column fields change only as the accessories or unit functions changes. The larger (lft side of the Message Window displays data entry instructions, error messages, and user response prompts. The smaller (right) side of the Message Window shows the oper- ating status ofthe unit (.e., Standby, Ready, etc.) Note...During STANDBY conditions, the message area will display a description to help the user determine the reason for the STANDBY status. The left side of the Message Window displays instructions for the action taking place (i.e., highlighting the Birth Date data fields brings instructions on entering the patient's date of birth). During fault conditions, such as an empty cassette holder, the Message Area requests a user response for corrective action. Errors that occur during operation also appear in the Message Area. In cases where user action can remedy the error, appropriate prompts appear; in cases where the error condition is beyond the user's ability to “clear’, the mes- sage reads “Call Service”. The Exposure Technique Window displays all the parameters by which the exposure will be conducted (i.c,, KV, mAs, mode, etc.). Note that the techniques available for change will dif- fer depending on the exposure mode selected (described laten. 4 Chapter 4: User Interface—The Run ModeM - IV (e)oletr-tel ea UOTE peat A co) Figure 4-2: The Run Mode Screen 2.0 The ID Column Data Fields ‘The ID Column data fields are in the left portion of the Run Mode Set Up Window, and con- sist of: * Patient and technologist identification + Patient gender and birth date + Exam views and billing codes + Exam comments + Compression mode ‘Te paragraphs that follow describe each data field in this column, and the information con- tained therein, 2.1 The ID Data Field The 1D data field, which holds up to 15 characters, including numbers, letters, and punctua- tion marks (comma, period, hyphen, space, etc.), contains the patient's personal identifica- tion number which must be entered to continue exam setup. To enter a valid 1D number perform the following: + Move the highlight to the ID data field. ‘+ Type the patient ID number up to 15 characters using the alphanumeric keys. ‘+ Press Enter to both register the entry and move the Cursor to the next data field. Aix, NatenThe Console sounds» waming “chirp” ifthe user tternpts lo bypas the 1D data field without entering a valid number. ‘The Pre-schedule feature permits the user to enter patient information prior to the scheduled appointment. When a pre-scheduled ID number is keyed in, ALL 1D column data fields are filled with the pre-scheduled information. Chapter 4: User Intorfaco-The Run Mode a72.2 The Name Data Field ws The Name data field contains the patient’s name, usually in the format of: last name, frst name, middle initial. The Name data field holds up to 24 characters, including letters and punctuation marks (commas, periods, hyphens, spaces, etc.) ‘Toenter the patient name, frst enter a valid 1D number, then perform the following: Highlight the Name data field. ‘Type in the last name of the patient, followed by a comma () ‘Type a space, then the patient’ first name. ‘Type a space, then type the patient's middle initial, followed by a period () Press Enter to register the name and move the highlight to the next data field. Note...A patient Name must be properly entered to permit the user to continue with the exam setup and enable the system to enter a READY status. The Console sounds a warning “chirp” if the user attempts to bypass the Name data field without making a proper entry. 2.3. The Birth Date Data Field & This data field contains the patient's date of birth in the selected format: MM/DDYYYY or DDIMM/YYYY. ‘The Birth Date data field holds up to ten characters and is entered by follow- ing the instructions below: MM/DD/YYYY Format (Month/Day/Year) Highlight the Birth Date Data Field. Enter the 2-digit month (01 through 12 are the only valid entries) ‘Type the slash (), then enter the 2-digit day (01 through 31 are the only valid entries) ‘Type the slash (), then enter the 4-digit year. Press Enter to register the birth date entry and move the highlight to the next data field DD/MM/YYYY Format (Day/Month/Year) Highlight the Birth Date Data Field. Enter the 2-digit day (01 through 31 are the only valid entries) ‘Type the slash (), then enter the 2-digit month (01 through 12 are the only valid entries). ‘Type the slash (), then enter the 4-digit year. Press Enter to register the birth date entry and move the highlight to the next data field Note...1f an invalid day or month is entered in the Birth Date data field, the system clears the data field and sounds a warning “chirp”. 48 CChoptor 4: User Inlrfaco-The Run ModeM - IV Operator's Manual 2.4 The Sex Data Field ‘The Sex data field displays the patient’s gender. The only acceptable entries are: + F (female) + Mimale) + O%other) ‘The default gender status is always female (F). To change the gender display of the Sex data field, perform the following: * Press the Appropriate letter designation (M or O).. + Press Enter to move the highlight to the next data field. AK NotenPressing ay eter other than the valid letters forthe gender designation causes the system software to automatically display the default gender (F). 2.5 The Comment Data Field Use the Comment data field to display simple remarks regarding the examination. This data field holds up to 25 characters, including numbers, letters, and punctuation marks (comma, period, hyphen, space, etc.) To enter a comment, use the following procedure: ‘+ Highlight the Comments data field. ‘+ Type in the comment up to 25 characters. ‘+ Press Enter to record the entry and move the highlight to the next data field. 2.6 The Tech ID Data Field The Tech ID data field contains the technologist’s personal identification code. This field holds up to 3 characters, including numbers, letters, and punctuation marks (comma, period, hyphen, space, etc.). Entering a Tech ID that has been previously defined in the Technologist Setup Mode causes the following to occur: ‘+ The preferred Compression mode is activated. + The first view in the predefined screening exam view sequence is displayed. * The view sequence is available without manually entering a CPT code. ‘+ Inan event where the Tech ID sequence is interrupted, the operator is required to select, the views for the remainder of exposures. Once a new patient ID is entered, the view sequence will return. ‘To enter the technologist’s ID code, perform the following: + Highlight the Tech ID data field. * Type the technologist’ identification code (typically initials) in the data field. + Press Enter to register the entry and move the Highlight to the next data field. CChopter 4: User Interfoce—The Run Mode “9M- IV lejeletrtelg 2.7 The CPT Code Data Field The 5-character CPT Code Data Field has two sections: + CPT Code Field + Exam Description Field ‘The CPT Code Field displays the billing code(s) for the scheduled exam. Use the predefined codes (CPT Code key), or manually enter a billing code (alphanumeric keys). ‘The Exam Description field displays the exam name that is associated with the chosen billing code in the CPT Code field. For example, ifthe billing code represents a normal breast screening technique, the Exam Description field will read “screening”. This area is not user accessible ‘The user can schedule CPT codes for each patient by performing the following: ‘+ Highlight the CPT Code data field on the Run Mode screen. + Press Change to scroll through the available CPT codes. (When scrolling through the codes, the data field appears dim (CPT Code is not yet scheduled). + Press Enter to accept and store the CPT Code for that patient. The data field appears bright (CPT Code is now scheduled). * Repeat this process to schedule multiple (10 maximum) codes for that patient. AR Note the dlpyed Cor Cade tena eclerted W the ier moves he Bihlipht bar trom the data field without first pressing Enter. ‘To view all the CPT Codes scheduled for a patient, press CPT Code to scroll through each scheduled code. 2.8 The Exam View Data Field ‘The Exam View data field shows the associated exam views for the selected CPT Code. ‘When the user enters a CPT Code, the frst view associated with the entered CPT code is dis- played. Press View to scroll through the remaining views available for the entered CPT Code. ‘The exam views appear in the data field as follows: + Bright when “Selected” in the CPT Setup + Dim when “Optional” in the CPT Setup Note that pressing View permits selection of only the exam views that were previously marked “Selected” or “Optional” in CPT Setup. Exam views defined as “Not Selected” are not available using View. ‘To schedule an exam view that is not predefined (Not Selected) for the CPT Code, perform the following: + Highlight the Exam View data field. + Press the appropriate mammography of exam views, + Press Enter to schedule the exam view forthe patient. > sw key or press Change to scroll through the 50 Chapter 4: User Interfaco-The Run Modo