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3Dimensions System User Guide

Chapter 2: General Information

Page 20

MAN-05085-002 Revision 002

DRAFT

Preview Copy-Generated May 30, 2018

2.6.2

Compliance Statements

The manufacturer states this device is made to meet the following requirements:

Medical – Applied electromagnetic radiation equipment as to electrical shock, fire and
mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005) and
CAN/CSA-C22.2 No. 60601-1 (2008)

•

CAN/CSA - ISO 13485-03 Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition,
2003-07-15)

•

CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005,
third edition, 2005-12), includes Corrigendum 1:2011

•

EN 60601-1:2006 Medical Electrical Equipment. General Requirements for Basic
Safety and Essential Performance

•

ETSI EN 300 330-1: V1.3.1, and ETSI EN 300 330-2: V1.5.1: 2006—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: V1.6.1, and ETSI EN 301 489-3: V1.8.1: 2008—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: 2009

•

FDA, 21 CFR [Parts 820, 900 and 1020]

•

IEC 60601-1 Ed. 3.0:2005 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance

•

IEC 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests

•

IEC 60601-1-3 Ed. 2.0:2008 Medical Electrical Equipment – Part 1-3: General
Requirements for Basic Safety and Essential Performance –Collateral Standard:
Radiation Protection in Diagnostic X-Ray Equipment

•

IEC 60601-2-28 Ed. 2.0:2010 Medical Electrical Equipment - Part 2-28: Particular
Requirements for the Basic Safety and Essential Performance of X-ray Tube
Assemblies for Medical Devices

•

IEC 60601-2-45 Ed. 3.0:2011 Medical Electrical Equipment – Part 2-45: Particular
Requirements for Basic Safety and Essential Performance of Mammographic X-Ray
Equipment and Mammographic Stereotactic Devices

•

RSS-210: Issue 7, 2007 Radio Standards Specification Low-power License-exempt
Radiocommunication Devices: Category I Equipment

•

ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential Performance, includes
amendment (2010)

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Содержание 3Dimensions

Страница 1: ......

Страница 2: ......

Страница 3: ...3Dimensions Digital Mammography System Digital Tomosynthesis System User Guide For Software Version 2 0 Part Number MAN 05085 002 Revision 002 May 2018...

Страница 4: ...of Hologic Inc and or its subsidiaries in the United States and or other countries All other trademarks registered trademarks and product names are the property of their respective owners This product...

Страница 5: ...and Intelligent 2D Warnings 5 1 6 3 C View and Intelligent 2D Theory of Operation 6 1 7 User Profiles 6 1 7 1 Mammography Technologist 6 1 7 2 Radiologist 6 1 7 3 Medical Physicist 7 1 8 Training Requ...

Страница 6: ...al Tests 34 4 3 3 Collimation 42 4 3 4 Shifting Paddles 43 4 4 Emergency Off Switches Functionality 44 4 5 How to Turn Off the System 44 4 6 How to Remove All Power from the System 44 5 User Interface...

Страница 7: ...ing Sequence of Events 72 6 3 3 How to Accept a Rejected Image 73 6 3 4 How to Accept or Reject a Pended Image 73 6 4 How to Correct and Reprocess Implant Images 73 6 4 1 If the Image Is Not Accepted...

Страница 8: ...the Gantry 99 8 1 3 At the Acquisition Workstation 100 8 2 Screening Procedure Example 100 8 2 1 Position the Patient 101 8 2 2 Set the Exposure Techniques 101 8 2 3 Acquire the Exposure 101 8 3 Proc...

Страница 9: ...ion 133 A 5 Tubestand Technical Information 133 A 5 1 C Arm 133 A 5 2 Compression 134 A 5 3 X ray Tube 135 A 5 4 X ray Beam Filtration and Output 135 A 5 5 X ray Collimation 137 A 5 6 Light Field Indi...

Страница 10: ...C 6 1 Mobile System Controls and Functional Tests 148 C 7 Quality Control Tests 148 Appendix D Dose Information _________________________________________________149 D 1 EUREF Dose Tables 149 Glossary...

Страница 11: ...tor Log In Screen 31 Figure 18 C arm Control Panel left side shown 32 Figure 19 Emergency Off Switch Functionality 44 Figure 20 Universal Acquisition Workstation Power Buttons 44 Figure 21 An Example...

Страница 12: ...Localization Crosshair Device 95 Figure 64 How to Install and Remove the Magnification Crosshair Device 96 Figure 65 Example of a Screening Procedure Screen 100 Figure 66 Exposure In Progress 102 Figu...

Страница 13: ...9 Figure 94 Universal Acquisition Workstation Measurements 130 Figure 95 Mobile Universal Acquisition Workstation Measurements 131 Figure 96 UPS LCD Display 142 Figure 97 Keyboard Tray Lock Knob 146 F...

Страница 14: ......

Страница 15: ...MLO Rotation 41 Table 10 C arm Collimation 42 Table 11 Shifting Paddle 43 Table 12 Taskbar Menus 46 Table 13 The Select Patient Screen 48 Table 14 Filter Tab Options Require Access Privileges 54 Tabl...

Страница 16: ......

Страница 17: ...se in the same clinical applications as a 2D mammography system for screening mammograms Specifically the 3Dimensions system can be used to generate 2D digital mammograms and 3D mammograms Each screen...

Страница 18: ...ening 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...

Страница 19: ...te has several white papers and summary cards about breast imaging publications See the documents at http www hologic com en learning center white papers breastimaging Independent publications have ex...

Страница 20: ...kenaasen U Ekseth U Izadi M Hofvind S Gullien R Radiology 2014 Jun 271 3 655 63 doi 10 1148 radiol 13131391 Epub 2014 Jan 24 http www ncbi nlm nih gov pubmed 24484063 Breast Cancer Screening Using Tom...

Страница 21: ...hesis images to make a clinical decision or diagnosis 1 6 2 C View and Intelligent 2D Warnings Warning Do not make a clinical decision or diagnosis from the C View or Intelligent 2D images without rev...

Страница 22: ...gital Mammography Image object format The site PACS administrator in consultation with Hologic connectivity engineers can select the output format most appropriate for the site s IT infrastructure and...

Страница 23: ...o known as peer training Additionally the user manual is a guide for directions on how to use the system All users must make sure that they receive training on correct operation of the system before u...

Страница 24: ...hall extend to Hologic s customers to the extent permitted by the manufacturer of such non Hologic Manufactured Equipment Hologic does not warrant that use of Products will be uninterrupted or error f...

Страница 25: ...Equalization terminal Protective Earth terminal OFF power ON power Discard electrical and electronic equipment separately from standard waste Send decommissioned material to Hologic or contact your se...

Страница 26: ...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 f...

Страница 27: ...002 Revision 002 Page 11 DRAFT Preview Copy Generated May 30 2018 2 General Information 2 1 System Overview Figure 1 3Dimensions System Figure Legend 1 Tubestand Gantry and C arm 2 Gantry 3 C arm Tube...

Страница 28: ...age 12 MAN 05085 002 Revision 002 DRAFT Preview Copy Generated May 30 2018 2 1 1 C Arm Overview Figure 2 C arm Overview Figure Legend 1 Tube Arm 2 Patient Face Shield 3 Compression Device 4 Image Rece...

Страница 29: ...st must remember the health hazards of x rays 2 3 Warnings and Precautions This system is classified as CLASS I TYPE B APPLIED PART IPX0 permanently connected equipment continuous operation with short...

Страница 30: ...oltages WARNING The user must correct problems before the system is used Contact an approved service representative for preventive maintenance WARNING After power failure remove the patient from the s...

Страница 31: ...nd the radiation shield during the exposure Warning Do not move the C arm while the system retrieves the image Warning If a paddle touches possible infectious materials contact your Infection Control...

Страница 32: ...nd not a normal computer Only make approved changes to the hardware or software Install this device behind a firewall for network security The computer virus protection or network security for this me...

Страница 33: ...le 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 2 4 Emergency Off Switches The Emergency Off switches...

Страница 34: ...of the manufacturer 2 6 1 Compliance Requirements The manufacturer has the responsibility for the safety reliability and performance of this equipment with the following provisions The electrical inst...

Страница 35: ...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 an...

Страница 36: ...tromagnetic 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 2009 FDA 21 CFR Parts 8...

Страница 37: ...3Dimensions System User Guide Chapter 2 General Information MAN 05085 002 Revision 002 Page 21 DRAFT Preview Copy Generated May 30 2018 2 7 Label Locations Figure 4 Label Locations...

Страница 38: ...e 2 Electrical Shock Warning 3 System Model 4 Gantry Nameplate 5 Potential Equalization Terminal 8 Tomographic Mammography Detector 6 Wheelchair Warning for Footswitch 7 Emergency Stop Switch 9 Vendor...

Страница 39: ...18 3 System Controls and Indicators 3 1 System Power Controls Figure 5 System Power Controls Figure Legend 1 Gantry Power Circuit Breaker 2 Emergency Off Switch two on the Gantry one on the Acquisitio...

Страница 40: ...rated May 30 2018 3 2 Tubestand Controls and Indicators Figure 6 Tubestand Controls and Indicators Figure Legend 1 Rotation Angle Displays each side 2 C arm Control Panels each side 3 Compression Devi...

Страница 41: ...play 3 2 2 Compression Device Controls and Display Figure Legend 1 Manual Compression Handwheels 2 Paddle Shift Buttons 3 AEC Sensor Buttons 4 Compression Device Display 5 FAST Compression Mode Slide...

Страница 42: ...Legend 1 MLO Rotation 2 C arm Zero 3 Light Field Lamp 4 Motor Enable 5 Collimator Override 6 Clockwise C arm Rotation 7 C arm Up and Down 8 Counterclockwise C arm Rotation 9 Compression Up 10 Compres...

Страница 43: ...ch footswitch in a position where when used they remain in reach of the Emergency Off Switches Warning Position the footswitches to prevent accidental operation by a patient or wheelchair To use the f...

Страница 44: ...and Displays Figure Legend 1 Height Adjustment Switch 2 Keyboard in drawer 3 Bar Code Scanner 4 Control Monitor 5 Fingerprint Scanner 6 Emergency Off Switch 7 Image Display Monitor 8 X ray Activation...

Страница 45: ...o the view of the Operator 2 Make sure that all three Emergency Off switches are in the reset position unpushed Figure 14 Turn to Reset the Emergency Off Switches 3 Make sure that the Gantry circuit b...

Страница 46: ...antry then automatically powers on Figure 16 Startup Screen Note The Startup screen includes a Shutdown button that turns off the system and a Reboot button that restarts the system Note The system ca...

Страница 47: ...Log In 1 Select the Log In button on the Startup screen 2 The Select an Operator Log In screen opens and shows a list of Manager and Technologist user names If necessary select the Show All button to...

Страница 48: ...ion Correct operation Incorrect operation Note If Quality Control tasks are due the Select Function to Perform screen opens You can perform the quality tasks or you can select Skip 4 3 Perform the Fun...

Страница 49: ...on Down button x The compression brake engages x The light field lamp illuminates x The compression device lowers Note When you press the Compression Down button the compression brake remains engaged...

Страница 50: ...Movement Table 3 C arm Up and Down Movement Function Functional Test C arm Up Press the C arm Up button x C arm movement stops when the button is released x C arm movement stops when the C arm reaches...

Страница 51: ...Movement Function Functional Test C arm Down Press the C arm Down button x C arm movement stops when the button is released x C arm movement stops when the C arm reaches the lower travel limit x C ar...

Страница 52: ...Counterclockwise Rotation Function Functional Test Counterclockwise C arm Rotation Press the Counterclockwise C arm Rotation button item 1 to start counterclockwise C arm rotation C arm movement stop...

Страница 53: ...5 C arm Clockwise Rotation Function Functional Test Clockwise C arm Rotation Press the Clockwise C arm Rotation button item 1 to start clockwise C arm rotation C arm movement stops when the switch is...

Страница 54: ...RAFT Preview Copy Generated May 30 2018 Table 6 C arm Rotation Switch Function Functional Test C arm Rotation Switch Push the C arm Rotation switch away from you to move the C arm toward you Pull the...

Страница 55: ...Stop switch Motor Enable Press the Motor Enable button and a Rotation button at the same time to enable auto rotation movement clockwise or counterclockwise C arm Zero Press the Motor Enable button an...

Страница 56: ...Generated May 30 2018 Table 8 Automatic C arm Clockwise Rotation Function Functional Test Automatic Clockwise C arm Rotation Press the Motor Enable button item 1 and the Clockwise C arm Rotation butt...

Страница 57: ...atic MLO Rotation Function Functional Test Automatic Tubehead Rotation to Zero Position Position the C arm at an angle greater than 15 degrees Press the MLO Rotation button item 1 The Tubehead moves a...

Страница 58: ...on to show the x ray field then press the Collimator Override button to select an x ray field Light Field Lamp For compression paddles Press the Light Field Lamp button to see the x ray field for two...

Страница 59: ...le function Table 11 Shifting Paddle Function Functional Test Paddle Shift The 18 x 24 cm Screening Paddle moves approximately 2 5 cm into the left center or right position While compression is applie...

Страница 60: ...ures Refer to Close a Patient on page 62 2 From the Select Patient screen select the Log Out button 3 From the Startup screen select the Shutdown button 4 Select Yes in the confirmation dialog box 4 6...

Страница 61: ...tient screen opens when no quality control tasks are scheduled to be done Figure 21 An Example Select Function to Perform Screen To Complete a Scheduled Quality Control Task 1 Select a Quality Control...

Страница 62: ...e screen displays additional icons Select the icon to access information or perform system tasks Figure 22 Taskbar Table 12 Taskbar Menus Description Menu 1 Information Icon Select the Information ico...

Страница 63: ...ad icon If the Tubehead icon is red with a number next to it the system needs to wait the number of minutes shown before the next image can safely be taken Clear All Faults deletes all fault messages...

Страница 64: ...MAN 05085 002 Revision 002 DRAFT Preview Copy Generated May 30 2018 5 3 Select Patient Screen Figure 23 Select Patient Screen Table 13 The Select Patient Screen Item Description 1 Quick Search Search...

Страница 65: ...is displayed if you have the Advanced Workflow Manager on page 56 This tab shows the procedures acquired on all compatible networked systems Figure 24 Enterprise Tab 3 Buttons Many functions are acce...

Страница 66: ...ith Viewed Notices or patients with Unviewed Notices Select Open to access the Procedure screen for the selected patient 5 3 2 Open a Patient 1 Select a tab to show the desired list of patients 2 Sele...

Страница 67: ...it the Patient Records The Split function lets you move images when you acquired the images in the wrong procedure or the wrong patient Note You cannot split images for protected patients Note Archive...

Страница 68: ...lect Patient screen select the patient that has the images that need to be moved 2 Select the Split button The Split Patient Records screen opens 3 Select the images to move If all images are being mo...

Страница 69: ...to About Reclamation on page 110 1 In the Select Patient screen select one or more patients 2 Select the Delete button 3 When the confirmation prompt is shown select Yes Note The Technologists do not...

Страница 70: ...tab allows users with access privileges to add change or delete tabs in the Select Patient screen Refer to the following table Table 14 Filter Tab Options Require Access Privileges Change the current...

Страница 71: ...klist Select the Query Worklist button to search the Modality Worklist Provider for a patient or a list of patients There are two methods to enter the query information Keyboard Type the query informa...

Страница 72: ...Advanced Workflow Manager keeps track of all patients procedures and images acquired on all systems within an Advanced Workflow Manager cluster In addition the Advanced Workflow Manager synchronizes n...

Страница 73: ...t Add View Add a new view Edit View Assign a different view to an image Archive Export Send images to an output Print Print images Retrieve Query the configured devices with the current patient inform...

Страница 74: ...ted view The paddle moves to the new position Figure 30 Paddle Shift Buttons 5 4 3 Procedure Information Dialog Box To show procedure information select the Procedure Information button located below...

Страница 75: ...nail views for the procedure that was selected Available Procedures The table that follows shows the major groups of procedures that are available on the system Note Some procedures in the list show o...

Страница 76: ...placed RL Rolled Lateral RM Rolled Medial RI Rolled Inferior RS Rolled Superior NP Nipple in Profile AC Anterior Compression IMF Infra Mammary Fold AX Axillary Tissue 2 Select the tab then select the...

Страница 77: ...he view from the screen You can select a maximum of three View Modifiers See the figure The Add View Screen on page 60 for a description of the View Modifiers 4 Select Save then select OK to the Updat...

Страница 78: ...the procedure was discontinued from a list or add a new reason Return To Procedure Returns to the procedure If there are images marked as Pend a dialog box opens with the following options Accept All...

Страница 79: ...S Diagnostic Workstations CAD devices and printers from the Output Groups drop down list in the Procedure screen Note Images are not sent if an Output Group is not selected 5 6 2 Add or Edit an Output...

Страница 80: ...select OK Figure 36 An Example Custom Output Group 5 7 On Demand Outputs The On Demand Outputs are Archive Export or Print You can manually Archive Export or Print the currently opened patient until t...

Страница 81: ...orage Device drop down menu OR Select an output group from the Output Group drop down list 4 Select the Archive button to send the selected images to the selected archive Note Use the Manage Queue uti...

Страница 82: ...e 67 to prepare your print data 2 Select the film format from the film format area of the screen 3 Select a thumbnail image 4 Select the image mode Conventional Projection or Reconstruction The C View...

Страница 83: ...onstruction views Tomosynthesis option The C View button shows if the system is licensed for C View imaging 9 Select the printer options 10 View Thumbnail images 11 Select the film format number of ti...

Страница 84: ......

Страница 85: ...r Patient and procedure information can be displayed on the screen To turn the information on or off go to the Tools tab in the Procedure screen and select the Patient Information button Figure 40 Ima...

Страница 86: ...lable from 20 49 kV x Manual The user selects the kV mAs Focal Spot and Filter x AEC Auto Time The user selects the kV Focal Spot and Filter The system selects the mAs x AEC Auto kV The user selects t...

Страница 87: ...bol and a yellow background see the following figure Figure 41 Exposure In Progress An audible tone continues to sound during the exposure The audible tone is a continuous sequence of tones The tone s...

Страница 88: ...ou select Pend a question mark appears on the thumbnail image Figure 43 Marked Images in a Procedure 5 Repeat steps 1 through 4 for each view Note A manager user can configure the system to Auto Accep...

Страница 89: ...Auto Pend new images 6 4 How to Correct and Reprocess Implant Images You must correct the image if you acquire an implant or an implant displaced view without the Implant Present button activated 6 4...

Страница 90: ...ges involves use of the thumbnails image review tools and display modes Figure 44 Tools Tab Tomosynthesis option shown Figure Legend 1 Image Review Tools refer to Image Review Tools Tab on page 75 2 I...

Страница 91: ...ensor areas used for the exposure calculation The sensor areas display on the Image Display screen 9 The Patient Information button activates the patient information display 10 The Auto Hanging button...

Страница 92: ...egend 1 The Oval tool draws an oval marking on the image 2 The Ruler tool measures the distance between two points 3 The Freehand tool draws a freehand marking on the image 4 The Text tool adds a text...

Страница 93: ...red or yellow area review the selected image for noise and decide whether to reacquire the image Figure 47 Exposure Index Display Modes Use the buttons in the Display Modes area of the screen to selec...

Страница 94: ...tagged for printing 2 Up and Down arrows let you change between slices that contain notices 3 H anatomical reference to head direction 4 Slices that contain targets or are tagged for printing 5 Slices...

Страница 95: ...ic requirements Your system configuration may not have all the options and accessories included in this manual 1 Select the Contrast tab to access the I ViewTM 2D Contrast CE2D function Figure 50 I Vi...

Страница 96: ...nd Note You can adjust the default length of time for the Waiting Period and Optimal Imaging Period phases of the timer Refer to How to Set the Contrast Defaults on page 119 Figure 51 I View 2D Contra...

Страница 97: ...ted subtracted image Low Sub Shows both the low and sub screen images side by side in a split screen Caution Using I View 2D Contrast increases the recovery time the machine needs before more images a...

Страница 98: ...the Configure Contrast button to edit the contrast settings The Contrast Information dialog box opens Figure 53 I View 2D Contrast Information 2 Use the drop down menus to select the appropriate setti...

Страница 99: ...etractable Face Shield Magnification Stand and Localization Crosshairs are installed in slots on the C arm The slots have labels with icons to indicate the accessory that attaches in the slot Each acc...

Страница 100: ...all the Retractable Face Shield 1 Completely extend the Face Shield to the outer position 2 Align the hooks of the Face Shield with the mounting slots on the C arm indicated by a face shield icon 3 Pu...

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