Users Manual
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| Document Description | Users Manual |
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| Document Type | User Manual |
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| Date Submitted | 2010-12-03 00:00:00 |
| Date Available | 2010-12-03 00:00:00 |
| Creation Date | 2010-11-12 16:58:58 |
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| Document Lastmod | 2010-11-12 16:59:05 |
| Document Title | MAN-01964.book |
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| Document Author: | mhurley |
AF T AF T AF T AF User Manual Table of Contents Table of Contents List of Figures xi List of Tables xiii Preface xv AF 1.0 Intended Use Statements ...................................................................................................................... xv 1.1 Intended Use .................................................................................................................................. xv 1.2 Intended Use (Tomosynthesis Option) ............................................................................................ xv 2.0 System Capabilities ............................................................................................................................... xv 3.0 Users .................................................................................................................................................... xv 4.0 Skills Needed for System Use .............................................................................................................. xvi 5.0 Training Requirements ......................................................................................................................... xvi 6.0 Quality Control Requirements ............................................................................................................. xvi 7.0 Product Complaints ............................................................................................................................. xvi 8.0 Hologic Cybersecurity Statement ......................................................................................................... xvi 9.0 Warnings, Cautions, and Notes .......................................................................................................... xvii 10.0 Terms and Definitions ..................................................................................................................... xviii 11.0 International Symbols ........................................................................................................................ xix 12.0 Document Standards ......................................................................................................................... xix Chapter 1—General Information 1.0 System Description ................................................................................................................................. 1 1.1 Tubestand ........................................................................................................................................ 1 1.2 Acquisition Workstation ................................................................................................................... 2 2.0 Safety Information .................................................................................................................................. 3 2.1 General Safety .................................................................................................................................. 3 2.2 Patient Safety ................................................................................................................................... 4 2.3 Radiation Safety ............................................................................................................................... 5 2.4 Data Loss ......................................................................................................................................... 6 2.5 Equipment Damage .......................................................................................................................... 6 2.6 Emergency Off Switches ................................................................................................................... 7 2.7 Interlocks ......................................................................................................................................... 7 3.0 Compliance ............................................................................................................................................ 8 3.1 Compliance Requirements ............................................................................................................... 8 3.2 Compliance Statements .................................................................................................................... 9 4.0 Label Locations .................................................................................................................................... 10 Chapter 2—System Controls and Indicators 11 1.0 System Power Controls ......................................................................................................................... 11 2.0 Acquisition Workstation Controls and Indicators .................................................................................. 12 2.1 Premium Acquisition Workstation Controls and Displays ............................................................... 12 2.2 Standard Acquisition Workstation Controls and Displays ............................................................... 13 2.3 Keyboard ....................................................................................................................................... 13 2.4 Bar Code Scanner .......................................................................................................................... 13 2.5 Premium Acquisition Workstation Touchscreen Display ................................................................ 13 2.6 Standard Acquisition Workstation Control Display ......................................................................... 13 2.7 Preview Display ............................................................................................................................. 13 Part Number MAN-01964 User Manual Table of Contents 3.0 Tubestand Controls and Indicators ....................................................................................................... 14 3.1 C-Arm Controls ............................................................................................................................. 15 3.2 Compression Device Controls and Displays .................................................................................. 15 3.3 Tubehead Display ......................................................................................................................... 16 3.4 Dual Function Footswitches .......................................................................................................... 16 4.0 How to Turn On the Selenia Dimensions ............................................................................................. 17 4.1 Preparation .................................................................................................................................... 17 4.2 Startup ........................................................................................................................................... 17 4.3 Log In ............................................................................................................................................ 18 5.0 How to Change the Language .............................................................................................................. 18 6.0 Perform the Functional Tests ................................................................................................................ 19 7.0 How to Turn Off the System ................................................................................................................. 25 8.0 How to Remove All Power from the Acquisition Workstation .............................................................. 25 Chapter 3—The User Interface 27 AF 1.0 Select the Function to Perform ............................................................................................................. 27 2.0 How to Perform the Quality Control Tasks ........................................................................................... 28 3.0 The Select Patient Screen ..................................................................................................................... 29 3.1 How to Open a Procedure ............................................................................................................. 29 3.2 How to Add a New Patient ............................................................................................................ 30 3.3 How to Edit the Patient Information ............................................................................................... 30 3.4 How to Delete a Patient ................................................................................................................ 30 3.5 The Patient Filter Screen ................................................................................................................ 31 3.6 How to Refresh the Worklist .......................................................................................................... 32 3.7 How to Query the Worklist ........................................................................................................... 33 3.8 About the Admin Button ................................................................................................................ 33 3.9 How to Log Out ............................................................................................................................ 33 4.0 The Procedure Screen .......................................................................................................................... 34 4.1 How to Set the Exposure Parameters .............................................................................................. 34 4.2 How to Use the Implant Present Button ......................................................................................... 35 4.3 How to Acquire an Image .............................................................................................................. 35 4.4 How to Add or Remove a View ..................................................................................................... 36 4.5 How to Add a Procedure ............................................................................................................... 37 4.6 How to Edit a View ....................................................................................................................... 37 4.7 How to Close a Procedure ............................................................................................................. 38 5.0 How to Access Image Review Features ................................................................................................ 38 6.0 How to Use the Output Sets ................................................................................................................. 39 6.1 How to Select an Output Set ......................................................................................................... 39 6.2 How to Add or Edit an Output Set ................................................................................................. 39 7.0 How to Use the On-Demand Outputs .................................................................................................. 39 7.1 How to Archive ............................................................................................................................. 39 7.2 How to Print .................................................................................................................................. 40 7.3 How to Export ............................................................................................................................... 41 8.0 How to Use the Paddle Shift Feature .................................................................................................... 41 9.0 About the Taskbar ................................................................................................................................ 42 vi Part Number MAN-01964 User Manual Table of Contents Chapter 4—The Images 43 1.0 Introduction .......................................................................................................................................... 43 1.1 Conventional Sequence of Events ................................................................................................... 43 1.2 Tomosynthesis Sequence of Events (Tomosynthesis option) ............................................................ 43 2.0 How to Review the Images ................................................................................................................... 44 2.1 The Image Review Tools Tab ......................................................................................................... 45 2.2 Other Image Review Tools ............................................................................................................. 46 2.3 How to Correct and Reprocess Implant Images .............................................................................. 47 3.0 Send the Images to the Output Devices ................................................................................................ 47 Chapter 5—How to Use the Accessories 49 AF 1.0 Introduction .......................................................................................................................................... 49 2.0 How to Install Accessories on the C-Arm ..............................................................................................49 3.0 The Patient Face Shields ....................................................................................................................... 50 3.1 How to Install or Remove the Retractable Face Shield .................................................................... 50 3.2 How to Use the Retractable Face Shield ......................................................................................... 51 3.3 How to Install or Remove the Conventional Face Shield ................................................................ 52 4.0 Compression Paddles ........................................................................................................................... 53 4.1 Routine Screening Paddles ............................................................................................................. 53 4.2 Contact and Spot Compression Paddles ......................................................................................... 53 4.3 Localization Paddles ...................................................................................................................... 54 4.4 Magnification Paddles .................................................................................................................... 54 4.5 How to Install or Remove a Compression Paddle ........................................................................... 55 4.6 Maintenance and Cleaning ............................................................................................................ 55 4.7 Paddle Shift .................................................................................................................................... 55 4.8 FAST Compression Mode ............................................................................................................... 56 5.0 Magnification Stand .............................................................................................................................. 57 5.1 How to Install and Remove the Magnification Stand ...................................................................... 57 6.0 Crosshair Devices ................................................................................................................................. 58 6.1 How to Install and Remove the Localization Crosshair Device ....................................................... 58 6.2 How to Use the Localization Crosshair Device .............................................................................. 58 6.3 How to Install and Remove the Magnification Crosshair Device ....................................................59 6.4 How to Align the Crosshair Device ................................................................................................ 59 Chapter 6—Clinical Procedures 61 1.0 Standard Workflow ............................................................................................................................... 61 1.1 Preparation .................................................................................................................................... 61 1.2 At the Gantry ................................................................................................................................. 61 1.3 At the Acquisition Workstation ....................................................................................................... 61 2.0 Screening Procedure Example .............................................................................................................. 62 2.1 How to Position the Patient ............................................................................................................ 62 2.2 Set the Exposure Techniques .......................................................................................................... 62 2.3 How to Acquire the Exposure ......................................................................................................... 63 2.4 How to Automatically Store the Image ........................................................................................... 63 2.5 How to Accept a Rejected Image ................................................................................................... 63 2.6 How to Accept or Reject a Pended Image ...................................................................................... 63 Part Number MAN-01964 vii User Manual Table of Contents Chapter 7—Maintenance and Cleaning 65 1.0 General Information ............................................................................................................................. 65 1.1 For General Cleaning .................................................................................................................... 65 1.2 To prevent Possible Injury or Equipment Damage .......................................................................... 66 2.0 Acquisition Workstation ....................................................................................................................... 67 2.1 How to Clean the Preview Display ................................................................................................ 67 2.2 How to Clean the Touchscreen Display ......................................................................................... 67 2.3 How to Clean the Keyboard .......................................................................................................... 67 2.4 How to Clean the Fingerprint Scanner ........................................................................................... 67 3.0 Preventive Maintenance Schedule ....................................................................................................... 68 Chapter 8—System Administration Interface 69 1.0 How to Use the Admin Screen ............................................................................................................. 69 2.0 How to Use the System Tools .............................................................................................................. 72 2.1 The Radiologic Technologist Manager ........................................................................................... 72 Appendix A—Specifications 75 AF 1.0 Product Measurements ......................................................................................................................... 75 1.1 Tubestand (Gantry with C-Arm) ..................................................................................................... 75 1.2 Premium Acquisition Workstation ................................................................................................. 76 1.3 Standard Acquisition Workstation .................................................................................................. 77 2.0 Operation and Storage Environment .................................................................................................... 78 2.1 General Conditions for Operation ................................................................................................. 78 2.2 Storage Environment ...................................................................................................................... 78 3.0 Acquisition Workstation Technical Information ................................................................................... 78 4.0 Electrical Input ..................................................................................................................................... 79 4.1 Tubestand ...................................................................................................................................... 79 4.2 Acquisition Workstation ................................................................................................................ 79 5.0 Tubestand Technical Information ......................................................................................................... 79 5.1 C-Arm ........................................................................................................................................... 79 5.2 Compression ................................................................................................................................. 80 5.3 X-Ray Tube .................................................................................................................................... 80 5.4 X-Ray Beam Filtration and Output ................................................................................................. 81 5.5 X-Ray Collimation ......................................................................................................................... 82 5.6 Light Field Indication ..................................................................................................................... 82 5.7 X-Ray Generator ............................................................................................................................ 82 6.0 Imaging System Technical Information ................................................................................................. 82 6.1 Image Receptor ............................................................................................................................. 82 Appendix B—The System Messages and Alert Messages 83 1.0 Error Recovery and Troubleshooting .................................................................................................... 83 2.0 Types of Messages and Alert messages ................................................................................................. 83 2.1 Fault Levels ................................................................................................................................... 83 2.2 System Messages ........................................................................................................................... 84 viii Part Number MAN-01964 User Manual Table of Contents Appendix C—Dimensions Mobile 85 1.0 General Information ............................................................................................................................. 85 2.0 Conditions for Safety and Other Precautions ......................................................................................... 85 3.0 Mobile Specifications ........................................................................................................................... 86 3.1 Shock and Vibration Limits ............................................................................................................ 86 3.2 Coach Environment ........................................................................................................................ 86 4.0 Electrical Input ..................................................................................................................................... 86 4.1 Gantry ............................................................................................................................................ 86 4.2 Acquisition Workstation ................................................................................................................. 86 5.0 Prepare the System for Travel ............................................................................................................... 87 6.0 Prepare the System for Use ................................................................................................................... 87 7.0 Test the System after Travel .................................................................................................................. 88 7.1 Selenia Dimensions Controls and Functional Tests ......................................................................... 88 8.0 Quality Control Tests ............................................................................................................................ 88 89 List of Addenda 91 AF Index Part Number MAN-01964 ix User Manual AF Table of Contents Part Number MAN-01964 User Manual List of Figures List of Figures AF Figure 1-1: Selenia Dimensions .................................................................................................................... 1 Figure 1-2: Acquisition Workstations ............................................................................................................ 2 Figure 1-3: Label Locations......................................................................................................................... 10 Figure 2-1: System Power Controls ............................................................................................................. 11 Figure 2-2: Premium Acquisition Workstation Controls and Displays ......................................................... 12 Figure 2-3: Standard Acquisition Workstation Controls and Displays.......................................................... 13 Figure 2-4: Tubestand Controls and Indicators............................................................................................ 14 Figure 2-5: C-Arm Controls......................................................................................................................... 15 Figure 2-6: Compression Device................................................................................................................. 15 Figure 2-7: Compression Display................................................................................................................ 15 Figure 2-8: Tubehead Display..................................................................................................................... 16 Figure 2-9: Dual Function Footswitches...................................................................................................... 16 Figure 2-10: Premium Acquisition Workstation Power Buttons ................................................................... 17 Figure 2-11: Standard Acquisition Workstation Power Buttons ................................................................... 17 Figure 2-12: The Startup Screen.................................................................................................................. 17 Figure 2-13: How to Log In......................................................................................................................... 18 Figure 2-14: C-Arm Controls (left side shown) ............................................................................................ 19 Figure 3-1: An Example Select Function to Perform Screen......................................................................... 27 Figure 3-2: An Example Quality Control Screen.......................................................................................... 28 Figure 3-3: The Select Patient Screen.......................................................................................................... 29 Figure 3-4: How to Add a New Patient ....................................................................................................... 30 Figure 3-5: The Filter Tab in the Patient Filter Screen.................................................................................. 31 Figure 3-6: /The Generator Tab in an Example Procedure Screen ............................................................... 34 Figure 3-7: The Add View Screen ............................................................................................................... 36 Figure 3-8: The Add Procedure Dialog Box ................................................................................................ 37 Figure 3-9: The Edit View Screen................................................................................................................ 37 Figure 3-10: The Print Screen ..................................................................................................................... 40 Figure 3-11: Paddle Shift Buttons................................................................................................................ 41 Figure 4-1: The Preview Screen .................................................................................................................. 43 Figure 4-2: The Tools Tab (Tomosynthesis option shown)........................................................................... 44 Figure 4-3: Marked Images in a Procedure (Tomosynthesis option shown).................................................. 44 Figure 4-4: Image Review Tools.................................................................................................................. 45 Figure 4-5: Icons Available on the Notices Tab........................................................................................... 46 Figure 4-6: Exposure Index ......................................................................................................................... 46 Figure 4-7: Exposure Index ......................................................................................................................... 47 Figure 5-1: C-Arm Accessories.................................................................................................................... 49 Figure 5-2: How to Align the Retractable Face Shield on the C-Arm ........................................................... 50 Figure 5-3: Installation................................................................................................................................ 51 Figure 5-4: Operation ................................................................................................................................. 51 Figure 5-5: How to Install the Conventional Face Shield............................................................................. 52 Figure 5-6: How to Install a Compression Paddle ....................................................................................... 55 Figure 5-7: How to Remove the Compression Paddle ................................................................................. 55 Figure 5-8: The FAST Compression Mode Slide .......................................................................................... 56 Figure 5-9: Installation of the Magnification Stand ...................................................................................... 57 Figure 5-10: How to Attach the Localization Crosshair Device ................................................................... 58 Figure 5-11: How to Install and Remove the Magnification Crosshair Device ............................................. 59 Figure 6-1: Screening Example, Conventional Procedure............................................................................ 62 Figure 8-1: The Admin Screen .................................................................................................................... 70 Part Number MAN-01964 xi User Manual List of Figures 75 76 77 87 87 AF Figure A-1: Tubestand Dimensions ............................................................................................................ Figure A-2: Premium Acquisition Workstation Dimensions ........................................................................ Figure A-3: Standard Acquisition Workstation Dimensions......................................................................... Figure C-1: Keyboard Tray Lock Knob........................................................................................................ Figure C-2: How to Unlock the Keyboard .................................................................................................. xii Part Number MAN-01964 User Manual List of Tables List of Tables AF Table 2-1: C-Arm Functional Tests............................................................................................................... 19 Table 3-1: The Filter Tab Options (Require Access Privileges)...................................................................... 32 Table 3-2: Taskbar Menus ........................................................................................................................... 42 Table 7-1: User Preventive Maintenance ..................................................................................................... 68 Table 8-1: Admin Screen Functions ............................................................................................................. 71 Table 8-2: Radiologic Technologist Manager—Service Tools Functions....................................................... 73 Table A-1: Maximum mA Setting as a Function of kV .................................................................................. 81 Table B-1: System Messages ........................................................................................................................ 84 Part Number MAN-01964 xiii User Manual AF List of Tables xiv Part Number MAN-01964 User Manual Preface Intended Use Statements Preface 1.0 Intended Use Statements United States Federal Law restricts this device to use by, or on the order of, a physician. 1.1 Intended Use The Selenia® Dimensions® Full Field Digital Mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions Full Field Digital Mammography system is intended for use in the same clinical applications as traditional screen-film mammographic systems. Mammographic images can be interpreted on either hard copy film or soft copy review workstations. 1.2 Intended Use (Tomosynthesis Option) Note… In Canada, Tomosynthesis is not approved for screening, and must be used in conjunction with conventional mammography (2D image set). System Capabilities 2.0 AF The Selenia® Dimensions® Full Field Digital Mammography system acquires the digital mammography images which can be used for screening and diagnosis of breast cancer. The Selenia Dimensions system is intended for the clinical methods used with conventional Full Field Digital Mammography systems. The Selenia Dimensions system can acquire conventional full field digital mammograms in two dimensions and tomosynthesis mammograms in three dimensions. The screening examination has a conventional image set, or a conventional image set and a tomosynthesis image set. The system provides the user interfaces for the performance of screening and diagnostic mammograms: Conventional mammography with a digital image receptor equivalent in size to large mammography film. • Tomosynthesis scan with a digital image receptor equivalent in size to large mammography film (Tomosynthesis option). • Conventional digital mammogram and tomosynthesis scan during one compression (Tomosynthesis option). • A Technologist to acquire and review images • 3.0 Users • A Technologist to perform the Quality Assurance • A system administrator to enable permissions • A Medical Physicist to perform the Quality Control tests • A Radiologist can use the system with a Technologist • The service personnel to install the system, set the site system configurations and calibrations, and find faults Part Number MAN-01964 xv User Manual Preface Skills Needed for System Use 4.0 Skills Needed for System Use You must know how to do the following: 5.0 • Perform the trackball operations, like click, drag, and/or select • Perform the touchscreen operations • Select from menus • Type information in text fields • Select the options in the screens • Select the entries from drop-down lists • Use scroll bars Training Requirements Hologic™ does not accept the responsibility for injury or damage from incorrect system operation. AF Make sure that you receive training on the Selenia Dimensions before you use this system on patients. Hologic training programs address MQSA training requirements for any Technologist or Physician. Refer to this manual for directions on how to use Selenia Dimensions. 6.0 Quality Control Requirements The facilities in the United States must use the Quality Control Manual to create a Quality Assurance and Quality Control program. The facility must create the program to meet the requirements of the Mammography Quality Standards Act or to be accredited by ACR or another accreditation body. 7.0 The facilities outside the United States can use the Quality Control Manual as a guide to create a program to meet the local standards and regulations. Product Complaints Report any complaints or problem in the quality, reliability, safety, or performance of this product to Hologic. If the device has caused or added to patient injury, immediately report the incident to Hologic. (See the title page for contact information.) 8.0 Hologic Cybersecurity Statement Hologic continuously tests the current state of computer and network security to examine possible security problems. When necessary, Hologic provides the updates to the product. For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic Internet site. xvi Part Number MAN-01964 User Manual Preface Warnings, Cautions, and Notes 9.0 Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual: The procedures that you must follow accurately to prevent possible dangerous or fatal injury. Warning: The procedures that you must follow accurately to prevent injury. Caution: The procedures that you must follow accurately to prevent the damage to equipment, loss of data, or damage to files in software applications. Note… Notes indicate additional information. AF WARNING! Part Number MAN-01964 xvii User Manual Preface Terms and Definitions 10.0 Terms and Definitions American College of Radiology AEC Automatic Exposure Control Annotations Graphic or text marks on an image to indicate an area of interest. Collimator Device at the x-ray tube to control the area of the receptor that is exposed. Combo Procedure An image acquisition procedure for which the system takes a conventional mammography image and a tomosynthesis scan during a single patient compression (Tomosynthesis option). Conventional Mammography Single projection x-ray images of views for screening and diagnostic purposes. Diagnostic Workstation Softcopy workstation for diagnoses from digital images. DICOM Digital Imaging and Communications in Medicine EMC Electromagnetic Compatibility Gantry A part of the Selenia Dimensions that has the Detector, Generator and X-Ray Source, Positioning/Compression, Power Distribution, and Accessories Subsystems. HIS HTC™ AF Grid ACR Element within the Digital Image Receptor that reduces scatter radiation during the exposure. Hospital Information System High Transmission Cellular Grid Assembly of x-ray detector, x-ray scatter reduction grid, and carbon fiber cover. MQSA Mammography Quality Standards Act Image Receptor Notice xviii Annotations and comments per image communicated between Diagnostic Review Workstations, Technologist Workstations, and Acquisition Workstations. PACS Picture Archiving and Communications System. A computer and network system for the transfer and archive of digital medical images. Pend A mark on the image to indicate the Technologist is not positive about the image quality. Pended images must be Accepted or Rejected before the procedure is closed. Projection Images The group of x-ray images for tomosynthesis taken at different projection angles through the breast (Tomosynthesis option). RF Radio Frequency RIS Radiology Information System ROI Region of Interest SID Source to Image Distance Tomosynthesis An imaging procedure which combines a number of projections taken at different angles. The tomosynthesis images can be reconstructed to show planes or slices within the object (Tomosynthesis option). UPS Uninterruptible Power Supply Part Number MAN-01964 User Manual Preface International Symbols 11.0 International Symbols This section describes the International Symbols on the Selenia Dimensions. Connection for a conductor, except the Protective Earth terminal, for a direct connection between two or more pieces of electrical equipment. Protective Earth terminal Connector used for connection to ground of the line cord or ground cable of the equipment and no other purpose. Off Power disconnected from the main power source. On Power connection to the main power source. Off Only a part of the equipment is disconnected from the main power source. Only a part of the equipment is connected to the main power source. AF On Potential Equalization terminal WEEE Shows the compliance to the EC Directive on Waste Electrical and Electronic Equipment (WEEE). Dangerous Voltage Identifies an area of possible lethal voltage. Manufacturer Date of Manufacture Radio Icon X-ray Radiation This system transmits non-ionizing radiation Caution—Radiation 12.0 Document Standards When prompted to add text, enter the text written in monospaced font exactly as shown. Part Number MAN-01964 xix User Manual AF Preface Document Standards xx Part Number MAN-01964 User Manual Chapter 1—General Information System Description Chapter 1—General Information 1.0 System Description Tubestand AF 1.1 Figure 1-1: Selenia Dimensions Legend for Figure 1-1 1. Tubestand (Gantry and C-Arm) 2. Gantry 3. C-Arm (Tube Arm and Compression Arm) 4. Tube Arm 5. Compression Arm Part Number MAN-01964 User Manual Chapter 1—General Information System Description Acquisition Workstation AF 1.2 Figure 1-2: Acquisition Workstations Legend for Figure 1-2 1. Standard Acquisition Workstation 2. Premium Acquisition Workstation 3. Mobile Acquisition Workstation Part Number MAN-01964 User Manual Chapter 1—General Information Safety Information 2.0 Safety Information Read and understand this manual before you use the system. Keep the manual available during the patient procedures. Always follow all the instructions in this manual. Hologic does not accept the responsibility for injury or damage from wrong system operation. Hologic can arrange for training at your facility. The Selenia Dimensions has protective devices, but the Technologist must understand how to safely use the system. The Technologist must remember the health hazards of x-rays. 2.1 General Safety Do not open any of the panels. This system contains lethal voltages. AF WARNING! The Selenia Dimensions system is classified as CLASS I, TYPE B APPLIED PART, IPX0, permanently connected equipment, continuous operation with short term loading per IEC 60601-1. There are no special provisions to protect the system from flammable anesthetics or ingress of liquids. Per North American electrical safety requirements, you must use a Hospital Grade receptacle to provide a correct Ground. WARNING! WARNING! Electrical equipment used near flammable anesthetics can cause an explosion. WARNING! The user must correct problems before the system is used. The user must arrange for preventive maintenance by an authorized Service Engineer. Warning: This device contains dangerous material. Return to Hologic all material removed from service. Warning: If a paddle touches possible infectious materials, call your Infection Control Representative for decontamination instructions. Part Number MAN-01964 User Manual Chapter 1—General Information Safety Information The system is a medical device and not a normal computer. Do not make changes to the hardware or software that are not authorized. Install this device behind a firewall for network security. The computer virus protection or network security for this medical device is not provided (for example, a computer firewall). The network security and anti-virus provisions are the responsibility of the user. Note… Hologic does not provide the Gantry power cable for some countries. If the power cable is not provided, the installed cable must meet the following requirements and all local codes that apply: 3 conductor, 8 AWG (10 mm2) copper not more than 25 feet (7.62 meters) in length. Patient Safety To keep the isolation quality for the system, attach only approved accessories or options to the system. Only the authorized personnel can make changes to the connections. WARNING! After power failure, remove the patient from the system before you apply power. WARNING! AF 2.2 Caution: Keep a 1.5 meter safe distance between the patient and any non-patient devices. Non-patient system components (like the Workflow Manager, the diagnostic review workstation, or the hard copy printer) must not be installed in the Patient Area. WARNING! 1.5m Warning: Never leave the patient during the procedure if in contact with the mammography system. Part Number MAN-01964 User Manual Chapter 1—General Information Safety Information Keep the hands of the patient away from all buttons and switches at all times. Warning: The C-Arm movement is motorized. Warning: You increase the patient dose to high levels if you increase the AEC exposure adjustment setting. You increase the image noise or decrease image quality if you decrease the AEC exposure adjustment setting. Warning: Put both footswitches away from the patient and C-Arm area to prevent any accidental footswitch use. When the patient has a wheelchair, put the footswitches away from the area. Warning: Control the access to the equipment according to local regulations for radiation protection. Radiation Safety 2.3 AF Warning: WARNING! This x-ray system can be dangerous to the patient and the user. Always follow the safety precautions for x-ray exposures. WARNING! The disk drives installed in this system are a Class I Laser Product. Prevent direct exposure to the beam. Hidden laser radiation exists if the case to a disk drive is open. Warning: For exposures except magnification case studies, always use the Face Shield. Warning: The Face Shield does not protect from radiation. Part Number MAN-01964 User Manual Chapter 1—General Information Safety Information The bar code scanner installed in this system is a Class II Laser Product. Prevent direct exposure to the beam. Hidden laser radiation exists if the cover is opened. Warning: You must keep your complete body behind the radiation shield for the time of the exposure for maximum protection from x-ray exposure. Data Loss Do not move the C-Arm while the system retrieves the image. Caution: Never turn off the Acquisition Workstation Circuit Breaker except in emergency. The circuit breaker can turn off the Uninterruptible Power Supply (UPS) and risk data loss. Caution: Do not put any magnetic media near or on devices that create any magnetic fields, because stored data can be lost. Equipment Damage 2.5 Warning: AF 2.4 Warning: Do not put any heat source on the image receptor. Caution: Caution: To minimize possible damage from thermal shock to the Digital Image Receptor, follow the recommended procedure to turn off the equipment. Caution: Do not make any brightness or contrast adjustments to the display unless the SMPTE test pattern is on the screen. Caution: Use the least possible amount of cleaning fluids. The fluids must not flow or run. Caution: To prevent damage to the electronic components, do not spray disinfectant on the system. Part Number MAN-01964 User Manual Chapter 1—General Information Safety Information 2.6 Emergency Off Switches The Emergency Off switches remove the power from the Gantry and the Standard Acquisition Workstation Lift Mechanism. Do not normally use the Emergency Off switches to turn off the system. See Chapter 2, page 25, for complete information. 2.7 Interlocks The Selenia Dimensions has safety interlocks: The C-Arm vertical drive and rotation is disabled when 45 Newtons (10 pounds) or greater of compression force is displayed. • If the x-ray button is released before the end of the exposure, the exposure stops and an alarm message appears. • When in Tomo mode, the system does not allow the Grid in the x-ray field (Tomosynthesis option). • Mirror and Filter interlocks prevent the x-ray exposure when the Light Field Mirror or the Filter is not aligned. AF • Part Number MAN-01964 User Manual Chapter 1—General Information Compliance 3.0 Compliance This section describes the mammography system compliance requirements and the responsibilities of the manufacturer. 3.1 Compliance Requirements The manufacturer has the responsibility for the safety, reliability, and performance of this equipment with the following provisions: The electrical installation of the room meets all requirements. • The equipment is used according to Instructions for Use. • The assembly operations, extensions, adjustments, changes, or repairs are performed only by authorized persons. • The network and communication equipment must be installed to meet IEC Standards. The complete system (network and communications equipment and Selenia Dimensions Mammography System) must be in compliance with IEC 60601-1 and IEC 60601-1-1. Portable and Mobile RF communications can affect Medical electrical Equipment. Caution: Medical Electrical Equipment needs special precautions about EMC and must be installed, put into service and used according to the EMC information provided. AF Caution: • The use of unauthorized accessories and cables can result in increased emissions or decreased immunity. To keep the isolation quality for the system, attach only approved Hologic accessories or options to the system. Caution: Caution: The Medical Electrical (ME) Equipment or ME System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the ME Equipment or ME System should be observed to verify normal operation in the configuration in which it is used. Caution: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the equipment or shielding the location. Caution: Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment. Part Number MAN-01964 User Manual Chapter 1—General Information Compliance Caution: 3.2 This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Compliance Statements The manufacturer states this device is made to meet the following requirements: • • • CAN/CSA ISO 13485:2003 CAN/CSA: Medical Electrical Equipment Part 1: C22.2 No. 601.1–M90 (R2005)— General Requirements for Safety EN 60601-1:1990 +A1+A11+A12+A2+A13 Medical Electrical Equipment—General Requirements for Basic Safety and Essential Performance ETSI EN 300 330-1 V1.7.1(2010-02)—Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz ETSI EN 301 489-1: V1.8.1 (2008-04)—Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services FCC, 47 CFR [Part 15, Subpart C, Section 15.225] FDA, 21 CFR [Parts 820, 900 and 1020] IEC 60601-1:1988 +A1+A2:1995Medical Electrical Equipment—General Requirements for Safety IEC 60601-1-1:2000 Medical Electrical Equipment—Collateral Standard: Safety Requirements for Medical Electrical Systems IEC 60601-1-2:2007 Medical Electrical Equipment—Collateral Standard: Electromagnetic Compatibility for Medical Electric Systems IEC 60601-1-3:1994 Medical Electrical Equipment—Collateral Standard: Requirements for Radiation Protection in Diagnostic X-ray Equipment IEC 60601-1-4:1996 +A1:1999 Medical Electrical Equipment—Collateral Standard: Programmable Electrical Medical Systems IEC 60601-2-28:1993 Medical Electrical Equipment—Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis IEC 60601-2-32:1994 Medical Electrical Equipment—Particular Requirements for the Safety of Associated Equipment of X-ray Equipment IEC 60601-2-45:2001 Medical Electrical Equipment—Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices RSS-210: Issue 7, 2007 UL 60601-1 1st Edition: Medical Electrical Equipment, Part 1—General Requirements for Safety AF • • • • • • • • • • • • • • Part Number MAN-01964 User Manual Chapter 1—General Information Label Locations Label Locations AF 4.0 Figure 1-3: Label Locations 10 Part Number MAN-01964 User Manual Chapter 2—System Controls and Indicators System Power Controls Chapter 2—System Controls and Indicators System Power Controls AF 1.0 Figure 2-1: System Power Controls Legend for Figure 2-1 Gantry Power Circuit Breaker 1. Emergency Off Switch (two on the Gantry, one on the Acquisition Workstation) 3. Acquisition Workstation Power Circuit Breaker 4. Computer Power Button 5. UPS Power Button 2. Part Number MAN-01964 11 User Manual Chapter 2—System Controls and Indicators Acquisition Workstation Controls and Indicators 2.0 Acquisition Workstation Controls and Indicators Premium Acquisition Workstation Controls and Displays AF 2.1 Figure 2-2: Premium Acquisition Workstation Controls and Displays Legend for Figure 2-2 1. Trackball 2. Scroll Wheel 3. Compression Release 4. Emergency Off Switch 5. Fingerprint Scanner 6. X-Ray Button (one on each side) 7. Touchscreen Display 8. Keyboard (in drawer) 9. CD/DVD Drive 10. Bar Code Scanner 11. LED for Preview Display Power 12. Preview Display 12 Part Number MAN-01964 User Manual Chapter 2—System Controls and Indicators Acquisition Workstation Controls and Indicators 2.2 Standard Acquisition Workstation Controls and Displays Legend for Figure 2-3 1. Keyboard 2. Control Display 3. Left X-Ray Switch 4. Emergency Off Switch 5. Bar Code Scanner (Optional) 6. Preview Display 7. CPU Reset Switch 8. Circuit Breaker Power On Switch 9. Mouse 10. DVD Drive 11. Height Adjustment Switch 12. UPS 13. Computer 15. UPS Power Button AF 14. Right X-Ray Switch Figure 2-3: Standard Acquisition Workstation Controls and Displays Keyboard 2.3 Use the keyboard in the front drawer of the Acquisition Workstation for data entry. 2.4 Bar Code Scanner Use this device for data entry from bar codes for patient or procedure records. 2.5 Premium Acquisition Workstation Touchscreen Display Use the Touchscreen or trackball to select items. 2.6 Standard Acquisition Workstation Control Display Use the Mouse to select items. 2.7 Preview Display See the images on the Preview Display. Part Number MAN-01964 13 User Manual Chapter 2—System Controls and Indicators Tubestand Controls and Indicators 3.0 Tubestand Controls and Indicators Legend for Figure 2-4 1. Rotation Angle Displays (each side) 2. C-Arm Controls (each side) 3. Compression Device 4. Patient Handles (each side) 5. Emergency Off Switches (each side) 6. Compression Handwheels 7. Patient Face Shield 8. Tubehead Display AF 9. Footswitches 14 Figure 2-4: Tubestand Controls and Indicators Part Number MAN-01964 User Manual Chapter 2—System Controls and Indicators Tubestand Controls and Indicators 3.1 C-Arm Controls The C-Arm Controls provide the Collimator and C-Arm functions. See Section 6.0, page 19. Figure 2-5: C-Arm Controls Compression Device Controls and Displays AF 3.2 Legend for Figure 2-6 1. Manual Compression Handwheels 2. Paddle Shift Buttons AEC Sensor Buttons 4. Compression Device Display 3. POSITAEC ION The FAST Compression Mode Slide 6. Paddle Clamp 5. Figure 2-6: Compression Device The Display on the compression device shows: • AEC Sensor Position • Compression Force (displays 0.0 when force is less than 4 pounds) • Compression Thickness • Angle of C-Arm after rotation (for 5 seconds) Figure 2-7: Compression Display Part Number MAN-01964 15 User Manual Chapter 2—System Controls and Indicators Tubestand Controls and Indicators 3.3 Tubehead Display The Tubehead Display shows: • SID • Filter Type • Collimator Setting • Paddle Position AF cm Rh SID: 70 9 C x2 Coll: 24 Figure 2-8: Tubehead Display Dual Function Footswitches 3.4 Put both footswitches away from the patient and C-Arm area to prevent any accidental footswitch use. When the patient has a wheelchair, put the footswitches away from the area. Warning: To use the footswitches: 1. Press the footswitch to actuate. 2. Release the switch to stop the movement. C-AR COMPR ES SION Legend for Figure 2-9 1. C-Arm Down 2. C-Arm Up 3. Compression Down 4. Compression Up Figure 2-9: Dual Function Footswitches 16 Part Number MAN-01964 User Manual Chapter 2—System Controls and Indicators How to Turn On the Selenia Dimensions 4.0 How to Turn On the Selenia Dimensions 4.1 Preparation 1. Reset all three Emergency Off switches. 2. Make sure that both system circuit breakers are in the On position. 3. Remove any obstructions to the C-Arm movement and to the view of the Operator. 4.2 Startup Figure 2-11: Standard Acquisition Workstation Power Buttons 1. Acquisition Workstation Circuit Breaker 2. Computer Power Button 3. UPS Power Button AF Figure 2-10: Premium Acquisition Workstation Power Buttons Legend for Figure 2-10 and Figure 2-11 1. If the UPS was shut down, press the UPS power button (at the rear of the Premium Acquisition Workstation or on the side of the Standard Acquisition Workstation). 2. Press the computer power button at the rear of the Acquisition Workstation. Figure 2-12: The Startup Screen 3. Select the Log In button. Note… Part Number MAN-01964 The Startup screen includes a Shutdown button that turns off the system, and a Reboot button that restarts the system. 17 User Manual Chapter 2—System Controls and Indicators How to Change the Language Note… Log In AF 4.3 The system requires between five minutes and forty-five minutes to prepare for image acquisition. The wait time depends on the detector power configuration. A timer in the Taskbar displays the wait time before the system is ready. Do not acquire clinical or QC images unless the System Status Icon indicates the system is Ready. Figure 2-13: How to Log In When the user Log In screen displays, all Managers and Technologists show in the list of Operators. 1. To display the Service, Applications, and Physicists user names, select the Show All button. 2. Select your user name, enter your password, and select the Log In button. Or Validate your fingerprint. 5.0 How to Change the Language 1. Select the Admin button. 2. Select the My Settings option. 3. From the Locale field, select a language from the drop-down menu. 4. Select the Save button, then select the OK button to the Update Successful message. The selected language displays. 18 Part Number MAN-01964 User Manual Chapter 2—System Controls and Indicators Perform the Functional Tests 6.0 Perform the Functional Tests Legend for Figure 2-14 1. Compression Release 2. (Provisional use) 3. Light Field Lamp 4. (Provisional use) 5. Collimator Override 6. Clockwise C-Arm Rotation 7. C-Arm Up and Down 8. Counterclockwise C-Arm Rotation 9. Compression Up 10. Compression Down A C-Arm control panel is on both the left and right sides of the Gantry. Figure 2-14: C-Arm Controls (left side shown) AF Perform the Functional Tests as part of your monthly visual checklists to make sure that the control operates correctly. Table 2-1: C-Arm Functional Tests Function Compression Down Compression Up Functional Test Press a Compression Down button: • The compression brake engages. • The light field lamp illuminates. • The compression device lowers. Note… When you press the Compression Down button, the compression brake remains engaged until the Compression Release button is pressed. Compression down movement stops: • When you release the button. • When you reach the Down Force limit. • When you reach the lower travel limit. Press a Compression Up button: • The Compression Device moves toward the top. • The Compression Up button does not release the Compression Brake. Compression Up movement automatically stops: Part Number MAN-01964 • When you release the button. • When you reach the upper travel limit. 19 User Manual Chapter 2—System Controls and Indicators Perform the Functional Tests Table 2-1: C-Arm Functional Tests Function Compression Release Press the Compression Release button: • The Compression Motor Brake releases. • The Compression Device lifts. Press the C-Arm Up button: • The C-Arm movement automatically stops when the button is released. • The C-Arm movement automatically stops when the C-arm reaches the upper travel limit. • The C-Arm movement is disabled when a compression force of 45 N (10 pounds) or greater is applied. AF C-Arm Up Functional Test 20 Part Number MAN-01964
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