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Trident HD Specimen Radiography System User Guide

Chapter 2: General Information

MAN-05478-002 Revision 003

Page 11

2.5 Compliance

This section describes the system compliance requirements and the responsibilities of the
manufacturer.

2.5.1 Compliance Requirements

The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:

•

The equipment is used according to the 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.

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:
The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required), this equipment might not offer
sufficient protection to radio frequency communication services. The user may need
to take mitigation measures, such as relocating or re-orienting the equipment.

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, make sure
that the ME Equipment or ME System operates correctly in this configuration.

Caution:
Changes or modifications not expressly approved by Hologic could void your
authority to operate the equipment.

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Содержание Trident HD

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Страница 2: ......

Страница 3: ...Trident HD Specimen Radiography System User Guide For Software Version 1 0 Part Number MAN 05478 002 Revision 003 August 2018...

Страница 4: ...ited States and or other countries All other trademarks registered trademarks and product names are the property of their respective owners This product may be protected by one or more U S or foreign...

Страница 5: ...roduct Complaints 2 1 10 Hologic Cybersecurity Statement 3 1 11 Symbols 3 1 12 Descriptions of Warnings Cautions and Notes 4 2 General Information______________________________________________________...

Страница 6: ...ect an Output Group 37 4 4 How to Access Image Review Features 37 4 5 How to Use the Output Groups 37 4 5 1 Add or Edit an Output Group 37 4 6 How to Use the On Demand Outputs 38 4 6 1 How to Archive...

Страница 7: ...dure Tabs 68 9 5 System Tools 69 9 5 1 System Tools for the Radiologic Technologist Manager 69 9 6 Archive Tool 70 9 7 How to Change the Default Lock Out Time 72 Appendix A System Specifications _____...

Страница 8: ...System User Guide Table of Contents viii MAN 05478 002 Revision 003 Glossary of Terms______________________________________________________________79 Index ____________________________________________...

Страница 9: ...lit Patient Records 29 Figure 17 Select the Correct Patient to Split Patient Records 30 Figure 18 Filter Tab in the Patient Filter Screen 31 Figure 19 Procedure Screen 34 Figure 20 Add Procedure Dialo...

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Страница 11: ...14 Table 2 The Taskbar Sections 23 Table 3 Filter Tab Options Require Access Privileges 32 Table 4 The Procedure Screen 34 Table 5 Required Procedures 59 Table 6 User Preventive Maintenance 63 Table 7...

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Страница 13: ...workflow thus reducing the time the patient needs to be under examination 1 2 System Capabilities The Trident system acquires and displays the radiographic images of surgical and core specimens taken...

Страница 14: ...r a period ending on the expiration date shown on their respective packages v licensed Software is warranted to operate in accordance with published specifications vi Services are warranted to be supp...

Страница 15: ...gic products refer to the Hologic Internet site at www Hologic com 1 11 Symbols This section describes the Symbols on this system Symbol Description ON for part of the equipment Potential Equalization...

Страница 16: ...s and Notes used in this manual WARNING The procedures that you must follow accurately to prevent possible dangerous or fatal injury Warning The procedures that you must follow accurately to prevent i...

Страница 17: ...ystem User Guide Chapter 2 General Information MAN 05478 002 Revision 003 Page 5 2 General Information 2 1 System Overview Figure 1 Trident HD System Figure Legend 1 Image Display Monitor 2 Control Di...

Страница 18: ...ay radiation 2 3 Warnings and Precautions WARNING Only trained Service Engineers authorized through Hologic can open any of the panels This system contains lethal voltages WARNING Electrical equipment...

Страница 19: ...ecting the console from power always grasp the plug at the insertion point and pull lightly NEVER pull on the cord to unplug the unit WARNING Before moving the console make sure that the power cord an...

Страница 20: ...console to tip over Warning Before moving the system rotate the Image Display monitor to a position that provides clear visibility while pushing the console Warning Do not move the console with exces...

Страница 21: ...or liquids on the touch screen or the touch pad Fluids or liquids on the touch screen and the touch pad can cause a malfunction Make sure that the touch screen and touch pad are clean and dry before...

Страница 22: ...hen handling and cleaning the specimen tray Caution The weight and mobility of this system require the following precautions Be careful when you move the system on uneven or sloped surfaces Make sure...

Страница 23: ...ce 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 The emissions cha...

Страница 24: ...IEC 61010 2 091 2012 3rd Edition Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 091 Particular Requirements for Cabinet X ray Systems EN 61326 1 2013 E...

Страница 25: ...Trident HD Specimen Radiography System User Guide Chapter 2 General Information MAN 05478 002 Revision 003 Page 13 2 6 Label Locations Figure 2 Label Locations...

Страница 26: ...dent HD Specimen Radiography System User Guide Chapter 2 General Information Page 14 MAN 05478 002 Revision 003 Table 1 System Labels 1 System Nameplate 2 X ray Device Warning 3 Electrical Shock Warni...

Страница 27: ...s Figure 3 System Components Figure Legend 1 Image Display Monitor 2 Control Display 3 Imaging Cabinet 4 Casters 5 Computer Power On Restart Button 6 USB Ports 7 Console Handle 8 X RAY Activation Butt...

Страница 28: ...net Components The console houses a shielded imaging cabinet The placement of the specimen tray determines the magnification level of the image Figure 4 Specimen Tray Positions Figure Legend 1 Specime...

Страница 29: ...ngs to show the center point the 1 5x magnification margins and the 2 0x magnification margins Figure 5 Specimen Tray Markings for the Full Field Detector Figure Legend 1 Center 2 2 0x Magnification M...

Страница 30: ...m in a location where you can easily access power connections and network connections 2 Connect the system power cord to the electrical outlet 3 If desired connect the network cable to the ethernet po...

Страница 31: ...sconnected 3 Wrap the power cord on the cord management plate 4 Make sure all components and cables are in a safe position on the console 5 Position the Image Display monitor so that you have an unobs...

Страница 32: ...003 4 Press the computer power button on the control display The computer powers on and the Login screen opens Figure 8 Computer Power Switch Figure 9 Login Screen 5 Enter your user name and password...

Страница 33: ...ns of power buttons Note To change the system language or other preferences refer to System Administration Interface on page 65 3 5 1 Windows 10 Information The Trident system software runs on the Win...

Страница 34: ...e Login screen opens 3 7 How to Turn Off the System 1 Close any open patient procedures 2 In the Select Patient screen select the Close button 3 At the Startup screen select the Shutdown button At the...

Страница 35: ...e Login screen My Settings opens the Edit Operator screen to review or edit Operator information or to change your password Print prints the displayed patient list to a connected printer Note this pop...

Страница 36: ...nd job information for the selected output and allows you to filter the queue display 6 System Status If the System Status console icon has a green check mark next to it the system is ready for use Se...

Страница 37: ...icular button Open Open the selected patient refer to Open a Patient on page 26 New Add a new patient refer to Add a New Patient on page 26 Edit Edit the patient information refer to Edit the Patient...

Страница 38: ...ect a patient from the list The Open button becomes active 3 Select Open to access the Procedure screen for that patient 4 2 2 Add a New Patient Figure 13 Add Patient Screens 1 In the Select Patient s...

Страница 39: ...sion 003 Page 27 4 2 3 Edit the Patient Information Figure 14 Edit Patient Information Screens 1 In the Select Patient screen select the patient name then select the Edit button 2 In the Edit Patient...

Страница 40: ...ecords Figure 15 Split Patient Records Screen The Split function lets you move images when you acquired the images in the incorrect procedure or the incorrect patient Note You cannot split images for...

Страница 41: ...t Name or Accession Number using the drop down list below the images 5 Enter the same patient information and select the Search button the magnifying glass 6 When the Patient name appears select the c...

Страница 42: ...iteria for example Patient Name or Accession Number using the drop down list below the images 5 Enter the search criteria and select the Search button the magnifying glass 6 When the Patient name appe...

Страница 43: ...the Delete button 3 When the confirmation dialog box opens select Yes Note A Primary System User can not delete patients but a Manager can Note Reclamation normally removes the requirement to delete p...

Страница 44: ...users with access privileges to add change or delete tabs in the Select Patient screen Refer to the following table Table 3 Filter Tab Options Require Access Privileges Change the current patient fil...

Страница 45: ...e order of the patient list tabs 4 2 7 How to Refresh the Worklist Select the Refresh Worklist button to update the patient lists 4 2 8 How to Query the Worklist Use the Query Worklist feature to sear...

Страница 46: ...iors Tab on page 48 2 Procedure Tabs Shows the current procedures for the patient Select the tab to select the desired procedure for the patient Note The tabs can be changed to display one or two line...

Страница 47: ...o Use the On Demand Outputs on page 38 Print Print refer to Print on page 39 Retrieve Query the configured devices with the current patient information Close Patient Exit the patient and procedure ref...

Страница 48: ...the simplified version of the Tools tab with less image review tools Figure 21 Tools Tab Simple Select the Advanced button to show the advanced version of the Tools tab with more image review tools Fi...

Страница 49: ...ls Refer to Tools Tab on page 46 for information 4 5 How to Use the Output Groups The images are sent automatically to the output devices in the selected Output Group when a patient is closed 4 5 1 Ad...

Страница 50: ...ce Select the List Store Device button and make your selection from the options that display OR Select the List Output Group button and make your selection from the options that display 3 Select the S...

Страница 51: ...your print information 2 Select the film format from the Options area of the page 3 Select a thumbnail image 4 Select the image display box on the right side of the screen to put the selected thumbna...

Страница 52: ...the printer options 7 View thumbnail images 8 Select the film format number of tiles 9 Create a new film 10 Delete the current film 11 Delete an image from the current film 12 Step through the film pa...

Страница 53: ...onitor Patient and procedure information can be displayed on the Image Display screen To turn patient and procedure information on or off go to the Tools tab in the Procedure screen and select the Pat...

Страница 54: ...e 4 In Manual mode select the kV and mAs values To increase or decrease an Exposure Technique in one step increments select then release the or button To move quickly through the values for an Exposur...

Страница 55: ...Button During the exposure The X RAY button changes to yellow to indicate that the x ray emission sequence has started The radiation symbol illuminates below the X RAY button See the following figure...

Страница 56: ...then press the X RAY button To stop an exposure before automatic termination press the X RAY button An error message is displayed To start another exposure after you stopped one before automatic term...

Страница 57: ...elect a thumbnail image The image opens in the preview area of the Procedure screen and on the Image Display monitor When the image review tools are used the preview image shows the relationship betwe...

Страница 58: ...n two points To move the measurement line click and drag the line to the new location 8 The Text tool adds a text note to the image without a marking 9 The Patient Information tool activates the patie...

Страница 59: ...e an image of the Image Display screen A thumbnail of the snapshot is added to the Procedure tab and the snapshot image is saved to the procedure Comments Tab Figure 30 The Comments Tab This feature a...

Страница 60: ...s in the Display Modes area of the screen to select the type of view to show on the Image Display monitor You can change between conventional 2D synthesized 2D tomosynthesis projections and reconstruc...

Страница 61: ...l layout with the 15 degree image on top and the 15 degree image on the bottom Cine Views Use the arrow buttons to manually move through a set of tomosynthesis images one at a time Use the play pause...

Страница 62: ......

Страница 63: ...Trident HD Specimen Radiography System User Guide Chapter 6 Sample Clinical Sequences MAN 05478 002 Revision 003 Page 51 6 Sample Clinical Sequences 6 1 Example Imaging Workflow Chapter 6...

Страница 64: ...Guide Chapter 6 Sample Clinical Sequences Page 52 MAN 05478 002 Revision 003 6 2 Example Sequence of Operation Step Where This Action Is Done Move the console to the correct location Lock the casters...

Страница 65: ...Trident HD Specimen Radiography System User Guide Chapter 6 Sample Clinical Sequences MAN 05478 002 Revision 003 Page 53 Start the system and log in...

Страница 66: ...Trident HD Specimen Radiography System User Guide Chapter 6 Sample Clinical Sequences Page 54 MAN 05478 002 Revision 003 Select the patient and procedure...

Страница 67: ...e Chapter 6 Sample Clinical Sequences MAN 05478 002 Revision 003 Page 55 Prepare the specimen per facility policy and center on the specimen tray Position the specimen tray in the imaging cabinet for...

Страница 68: ...Trident HD Specimen Radiography System User Guide Chapter 6 Sample Clinical Sequences Page 56 MAN 05478 002 Revision 003 Acquire the image...

Страница 69: ...Trident HD Specimen Radiography System User Guide Chapter 6 Sample Clinical Sequences MAN 05478 002 Revision 003 Page 57 Review the image Archive or export the images then close the patient...

Страница 70: ...raphy System User Guide Chapter 6 Sample Clinical Sequences Page 58 MAN 05478 002 Revision 003 Remove the specimen tray from the imaging cabinet Follow facility policy for specimen handling Turn off t...

Страница 71: ...Procedures The following procedures are necessary for correct system operation Table 5 Required Procedures Test Frequency Gain Calibration Monthly 7 2 How to Access the Quality Control Tasks From the...

Страница 72: ...nsert the Specimen Stage appears remove the specimen tray and place the acrylic block in the Imaging Cabinet Note Artifacts that appear on the acrylic block provided by the manufacturer must not be ov...

Страница 73: ...2 For Disinfecting To disinfect the system s components and surfaces Hologic recommends the following disinfecting solutions 10 chlorine bleach solution and water with one part commercially available...

Страница 74: ...w instructions from the manufacturer of the product you use for cleaning The instructions include the directions and precautions for the application and contact time storage wash requirements protecti...

Страница 75: ...he power cord appears damaged contact Hologic for replacement of the power cord 8 3 Maintenance 8 3 1 Preventive Maintenance Schedules Table 6 User Preventive Maintenance Action Recommended Frequency...

Страница 76: ...ion Perform X Ray Tub Alignment Evaluation Perform System Resolution Test Perform AEC Function Test Perform ACR Phantom Test Perform X Ray Leakage Test Change detector filter Check for mechanical inte...

Страница 77: ...nctions on the Admin screen A Primary Specimen User has access to some functions Figure 33 Admin Screen Table 8 Admin Screen Functions Section Button Screen Function Operators Manage Operators Add del...

Страница 78: ...ification of problems System Diagnostics Shows the status of all subsystems Preferences Set the system preferences About Shows system information Exposure Report Create a report of the number of expos...

Страница 79: ...een is accessed in two ways From the Select Patient screen select the System Status icon on the taskbar then select About From the Admin screen select the About button in the System group Figure 34 Sy...

Страница 80: ...Select Save then select OK to the Update Successful message The user interface changes to the selected language 9 4 Set Multi Line Procedure Tabs You can set the operator preferences to display more o...

Страница 81: ...nd users with Service permissions can access the System Tools utility The System Tools utility contains the configuration information about the system To access the utility select System Tools from th...

Страница 82: ...rt User Interface Change the options in the Software application Internationalization Select the local language and culture Troubleshooting AWS Allows for download of images Computer System Management...

Страница 83: ...results Note The Select All button in the right panel of the screen selects all the patients in the Patient List area The Clear button in the right panel of the screen clears selections Select the pr...

Страница 84: ...t the Export button 3 In the Export dialog box select the Target from the drop down list of media devices Figure 39 Export Screen 4 Select other options if necessary Anonymize to anonymize patient dat...

Страница 85: ...02 Revision 003 Page 73 Appendix A System Specifications A 1 Product Measurements Figure 40 Console Measurements A Height 169 cm 66 5 inches B Width 61 cm 24 inches C Depth 66 1 cm 26 inches Weight 12...

Страница 86: ...20 to 80 without condensing moisture A 2 2 General Conditions for Transport and Storage Console Temperature Range 10 C 14 F to 40 C 104 F after being stored for 48 hours 10 C 50 F to 35 C 95 F for up...

Страница 87: ...than 1600 x 1200 pixel resolution Control Display touch screen A 3 2 Network Environment Network Interface 10 100 1000 BASE T Ethernet Wi Fi a b g n ac 2 4 and 5 GHz bands A 4 Electrical Input Line V...

Страница 88: ...kV to 50 kV mA 1 mA mAs 20 mAs maximum A 6 Imaging System Technical Information A 6 1 Image Receptor Fluid Ingress The Image Receptor is protected from accidental spillage on the Cabinet floor Active...

Страница 89: ...errors repeat contact Hologic Technical Support B 2 Types of Messages and Alert messages B 2 1 Fault Levels There are five fault levels Warning Minor Major Critical and Alerts Warning Faults The Warn...

Страница 90: ...hat can prevent an exposure An Alert message remains active until the required action is complete or the condition does not exist B 2 2 System Messages Select the system status icon on the Taskbar to...

Страница 91: ...Automatic Exposure Control Annotations Markings on an image to indicate an area of interest DICOM Digital Imaging and Communications in Medicine PACS Picture Archiving and Communications System A com...

Страница 92: ......

Страница 93: ...6 specimen tray 17 connections connections 18 network connectivity 23 USB connection 15 18 Wi Fi connection 18 23 controls and indicators 15 controls system 15 cybersecurity statement 3 D data loss 6...

Страница 94: ...orklist 33 remove all power 22 requirements compliance requirements 11 quality control 2 59 retrieve 36 S safety general information 6 screen about screen 67 add patient 26 add procedure 35 admin scre...

Страница 95: ...system 19 U USB connection 15 18 user interface 23 W warnings and precautions 6 warnings cautions and notes defined 4 warranty statement 2 Wi Fi connection 18 23 window level 46 Windows 10 21 workflow...

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