Hologic Sentinelle Medical Vanguard Installation And Service Manual
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Hologic Sentinelle Medical Vanguard Installation And Service Manual

Hologic Sentinelle Medical Vanguard Installation And Service Manual

Breast tabletop coil for ge 3t mr750 and mr750w
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Vanguard 16Ch Breast Tabletop Coil for GE
3T MR750 and MR750w Installation and
Service Manual
Manufactured By:
Sentinelle Medical, a Division of Hologic
Distributed By:
GE Healthcare
SMI-1414-EN Rev. 005 - Installation and Service Manual
Page 1 of 51

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  • Page 1 Vanguard 16Ch Breast Tabletop Coil for GE 3T MR750 and MR750w Installation and Service Manual Manufactured By: Distributed By: Sentinelle Medical, a Division of Hologic GE Healthcare SMI-1414-EN Rev. 005 - Installation and Service Manual Page 1 of 51...
  • Page 2 Revision History Type Date Author Summary of Changes (Major/Minor) 16 DEC 2010 L. Mete Major Initial Release 02 FEB 2011 L. Mete Major Updated as per GEHC comments 14 FEB 2011 L. Jankowski Minor Updated with GEHC HSE comments Updated with riser components and new phantom positioner;...
  • Page 3 Damage in Transportation All packages should be closely examined at time of delivery. If damage is apparent, have notation “damage in shipment” written on all copies of the freight or express bill before delivery is accepted or “signed for” by a General Electric or Sentinelle Medical representative or a hospital receiving agent.
  • Page 4 ПРЕДУПРЕЖДЕНИ Това упътване за работа е налично само на английски език. Е • Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да осигури превод. • Не използвайте оборудването, преди да сте се консултирали и разбрали упътването за работа. (BG) •...
  • Page 5 WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache. (DE) • Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es Aufgabe des Kunden für eine entsprechende Übersetzung zu sorgen. • Versuchen Sie nicht diese Anlage zu warten, ohne diese Serviceanleitung gelesen und verstanden zu haben. •...
  • Page 6 ATENÇÃO Este manual de assistência técnica só se encontra disponível em inglês. (PT-PT) • Se qualquer outro serviço de assistência técnica solicitar este manual noutro idioma, é da responsabilidade do cliente fornecer os serviços de tradução. • Não tente reparar o equipamento sem ter consultado e compreendido este manual de assistência técnica. •...

  • Page 7: Table Of Contents

    Table of Contents Purpose ..............................10 Compatibility ............................... 10 Service Tools Required ..........................10 General Safety Requirements ......................10 3.1.1 Occupational Exposure to Infectious Agents ..............10 Definitions and Abbreviations ........................11 Performing Service ............................. 12 Precautions ............................. 12 Preparing for the Service Call ......................12 Recording the Service Call ......................
  • Page 8 Patient Support FRUs ........................43 RF System FRUs ..........................43 Padding Kit FRUs..........................44 Riser Kit FRUs ..........................44 10 FRU and Fastener Locations ........................45 10.1 Patient Support FRUs ........................45 11 Replacement Procedures ........................... 46 11.1 Compression Rail ..........................46 11.2 Table Alignment Tab ........................
  • Page 9 Note: There are sections in this manual that apply only to Sentinelle Medical (SMI) personnel or GE Healthcare (GEHC) personnel. These sections are noted using the following symbols. ONLY GEHC ONLY GE FE's shall only service systems that were sold by GEHC. Coils sold by GEHC will have a "Distributed by GE Healthcare"...

  • Page 10: Purpose

    Purpose The purpose of this manual is to provide detailed instructions to an SMI Service Technician or a GEHC field engineer for installation, testing, service and maintenance of the Vanguard 16ch Tabletop for GE MR750 and MR750w 3T MRI scanners. The Troubleshooting Table outlines the required steps to methodically assess and correct the reported problem(s).

  • Page 11: Definitions And Abbreviations

    Avoiding Exposure Before beginning work at a medical facility where you may encounter potential infection hazards: • Ensure that you have had a Hepatitis B vaccination. • Before beginning to work on equipment, check carefully for signs of blood or body fluids. •...

  • Page 12: Performing Service

    Performing Service 5.1 Precautions Before entering the MRI Room with the Vanguard system the following activities must be performed: • Thoroughly inspect the system to ensure loose ferrous/magnetic items are not present anywhere on the system. Loose objects can become airborne and/or travel at high velocity in the presence of the scanner, potentially causing harm to the Patient, Operator or equipment.

  • Page 13: Recording The Service Call

    5.3 Recording the Service Call Record the results of all activities performed including: • Any non-conformances that were discovered during unpackaging and installation or service and any remedial action taken. • Leave a completed service card and inform relevant staff members who are present that service is complete and indicate state of functionality.

  • Page 14: System Contents

    System Contents This section outlines the shipping contents of this system and locates the rating plate labels for product identification. Shipping Contents The Vanguard components are shipped in three groups; the Patient Support and accessories, RF system and padding kit. All should be verified with included packing list. Refer to page 3 of this manual for the Damage in Transportation section if damage is found.

  • Page 15: Rf System

    6.1.2 RF System Item Box # GEHC Part # SMI Part # Description 1 of 2 5407765-8 4000444-11 Interface Box 3T16Ch 1 of 2 5407765-6 4000445-11 Medial Array 3T16Ch 1 of 2 5407765-4 4000429-11 Lateral Array Right 3T16Ch 1 of 2 5407765-5 4000428-11 Lateral Array Left 3T16Ch...

  • Page 16: Padding Kit

    6.1.3 Padding Kit Box # Item GEHC Part # SMI Part # Description 2 of 2 5408291 SVC-00325 Pad Arm Support In 5408290 Kit 2 of 2 SVC-00326 Ramp Pad In 5408290 Kit 2 of 2 SVC-00327 Shoulder Bridge Pad (Qty 2) 2 of 2 5408289 SVC-00328...

  • Page 17: Riser Kit For Ge Discovery 750W Systems With Gem Option

    6.1.5 Riser Kit for GE Discovery 750w Systems with GEM Option Box # Item GEHC Part # SMI Part # Description 1 of 1 5407765-10 ASY-04625 Riser 1 of 1 5407765-13 SVC-00486 Riser Body Pad 1 of 1 SVC-00485 Riser Front Pad 5407765-14 Figure 4 6.2 Product Identification...
  • Page 18 Figure 6: Interface Box Label Figure 7: Lateral Single Loop Coil Left Label SMI-1414-EN Rev. 005 - Installation and Service Manual Page 18 of 51...
  • Page 19 Figure 8: Lateral Single Loop Coil Right Label Figure 9: Lateral Array Coil Left Label SMI-1414-EN Rev. 005 - Installation and Service Manual Page 19 of 51...
  • Page 20 Figure 10: Lateral Array Coil Right Label Figure 11: Medial Array Coil Label Figure 12: Medial Terminator Plug Label SMI-1414-EN Rev. 005 - Installation and Service Manual Page 20 of 51...

  • Page 21: Installation Procedure

    Installation Procedure Required installation time: 30-60 minutes. Installation of the Vanguard requires no tools and no mechanical settings to be performed. The accessories must all be connected and assembled and tested to ensure system is functioning correctly with the scanner. 7.1 Unpack and Set Up Unpack the Patient Support assembly, padding kit, riser kit (if applicable), and coil boxes while examining the components for damage.

  • Page 22: Vanguard Installation

    7.3 Vanguard Installation This section outlines the procedure that must be followed to setup the Patient Support and accessories for use. Verify all parts function correctly and are not damaged. 7.3.1 Patient Support Setup for the GE Discovery 750 System and GE Discovery 750w System without GEM Option Place the Tabletop on the 3.0T GE MRI System patient table with the foot end toward the bore so the Tabletop cable located at the foot end of the patient support can be securely plugged into the MR scanner.

  • Page 23: General System Function And Components

    To set up the Tabletop on the GE Discovery 750w System with GEM Option: 1. Place the riser on the patient table with the rounded end of the riser pointing away from the bore. 2. Place the patient support on the riser with the head end of the patient support toward the rounded end of the riser.
  • Page 24 Component Left Lateral Array Coil Medial Array Coil Right Lateral Array Coil Figure 17 Bilateral Imaging Components and Setup (Without Padding) Component Immobilization Frame Biopsy Grid Contralateral Breast Support Place Right and Left Single Loop Coils in Immobilization Frames Figure 18 Unilateral Intervention Setup and Components (Without Padding) SMI-1414-EN Rev.
  • Page 25 NOTE: Biopsy grids are not included with the GE catalog offering. These products can only be ordered directly from Sentinelle Medical. 7.3.4.1. About the Contralateral Breast Support The contralateral breast support holds the contralateral breast away to improve medial access during unilateral interventional procedures.
  • Page 26 7.3.4.2. Catchment Tray For unilateral and bilateral interventional procedures the catchment tray must be in place. This is a safety mechanism ensuring the MR guided needle device can safely be directed into the breast tissue. Figure 20: Inserting the Catchment Tray 7.3.4.3.

  • Page 27: Coil Data Disk Installation Procedure

    Coil Data Disk Installation Procedure 7.4.1 Personnel Requirements Required Persons Procedure Finalization 15 mins 45 minutes 7.4.2 Tools and Test Equipment Item Part# 16Ch Breast Coils by Sentinelle Coil Definitions Disc 5407766 Phantoms and phantom positioners are needed for See sections 6.1 and 7.5 the MCQA test.
  • Page 28 7 Coil configs are: C-GE_10Brst Int SMI C-GE_10BrstLt Int SMI C-GE_10BrstRt Int SMI C-GE_2Brst Int SMI C-GE_Breast SMI C-GE_LtBreast SMI C-GE_RtBreast SMI Figure 22: Confirmation of coil configurations installed 4. The 16Ch Sentinelle table also has one protocol that must be on the system. Open the Protocol Management tab.
  • Page 29 Note: The number(s) following the “24.” will differ by system. Figure 23: Confirmation of 16ch Sentinelle coil protocols installed 5. If the Sentinelle table configurations and protocols are on the system skip to the finalization steps in section 7.4.5. 6. To install the Sentinelle table configurations and protocols, insert the “16Ch Breast Coils by Sentinelle Coil Definitions Disc”...

  • Page 30: Finalization

    - Note the PASS message. - The lines selected show that the Sentinelle packages installed from the CD for a 3T system. - The statement that “coil ID is not in DB” is not an error message pertaining to the install.

  • Page 31: Qa Scanning

    7.5 QA Scanning Perform a QA scan of the phantoms to ensure all coils are working to specification. The QA scan must be completed for 16ch and 10ch configurations of the Vanguard. Note: QA scan test results should be determined using the procedure outlined below in Test 1 and 2 and entered into the Quality Assurance SNR Section in the Installation Verification Checklist which can be found in the Appendix.
  • Page 32 4. Add spherical GE phantoms and adjust lateral coils so that lateral coils lightly touch the phantoms as shown in Figure 26. Figure 26: 16 Channel - Phantom Setup 5. Landmark using the notch on the edge of the patient support as shown in Figure 27. Notch Figure 27: 16 Channel - Landmark Phantoms SMI-1414-EN Rev.
  • Page 33 6. Do not start a new patient; open the Tools box, and start MR Service Desktop. Select the top tab marked ‘Image Quality.’ In the side menu, select ‘Multi-Coil QA Tool’, then ‘Click here to start this tool.’ The program shown in Figure 28 will start: Figure 28: Screen Capture –...
  • Page 34 7. Click ‘Start’, and answer ‘Yes’ to the dialog box that opens. The MCQA program will run for approximately 10 minutes, and test each channel of the system independently. When the program finishes, the screen capture shown in Figure 29 will display. Figure 29: Screen Capture –...

  • Page 35: Test 2: 10-Channel Bilateral Breast Snr Verification

    MCQA Test Image Associated Coil GEHC P/N SMI P/N Test#=1 SIG_IMG=1 Left Lateral Array 5407765-5 4000428-11 Test#=1 SIG_IMG=2 Left Lateral Array 5407765-5 4000428-11 Test#=1 SIG_IMG=3 Left Lateral Array 5407765-5 4000428-11 Test#=1 SIG_IMG=4 Left Lateral Array 5407765-5 4000428-11 Test#=1 SIG_IMG=5 Medial Array 5407765-6 4000445-11 Test#=1 SIG_IMG=6...
  • Page 36 Figure 31: 10 Channel - Phantom Setup 5. Landmark using the notch on the edge of the patient support as shown in Figure 32. Notch Figure 32: 10 Channel - Landmark Phantoms 6. Do not start a new patient; open the Tools box, and start MR Service Desktop. Select the top tab marked ‘Image Quality.’...
  • Page 37 Figure 33: Screen Capture – MCQA Tool Start 7. Click ‘Start’, and answer ‘Yes’ to the dialog box that opens. The MCQA program will run for approximately 10 minutes, and test each channel of the system independently. When the program finishes, the screen capture shown in Figure 34 will display. SMI-1414-EN Rev.
  • Page 38 Figure 34: Screen Capture – MCQA Tool Finish 8. The MCQA program will display a PASS/FAIL indicator for each image (SIG_IMG in Figure 34) which corresponds to a particular channel on one of the coils tested. If you receive a FAIL indication, check that all coils are connected properly and rerun the test.

  • Page 39: Troubleshooting Tips

    MCQA Test Image Associated Coil GEHC P/N SMI P/N Test#=1 SIG_IMG=1 Left Single Loop 5407765-2 4000452-11 Test#=1 SIG_IMG=2 Medial Array 5407765-6 4000445-11 Test#=1 SIG_IMG=3 Medial Array 5407765-6 4000445-11 Test#=1 SIG_IMG=4 Medial Array 5407765-6 4000445-11 Test#=1 SIG_IMG=5 Medial Array 5407765-6 4000445-11 Test#=2 SIG_IMG=1 Medial Array 5407765-6...

  • Page 40: System Storage

    7.7 System Storage When installation is complete, store the system as directed by the customer or inside the scanner room in an area where it will not pose a hazard or impede access to any part of the room. The storage environment should be 1.5m x 1m x 1m or 60in x 40in x 40in and must meet the criteria listed in the table below.

  • Page 41: Troubleshooting

    Troubleshooting GE FE's shall service systems that were sold by GEHC. Coils sold by GEHC will have a "Distributed by GE Healthcare" label next to the rating plate on the underside of the patient support. If the Vanguard is not functioning correctly, steps must be taken to troubleshoot the problem by analysing the symptoms displayed and identifying the cause.

  • Page 42: Mechanical Troubleshooting

    8.2 Mechanical Troubleshooting Mechanical problems can be addressed by identifying and replacing damaged or worn components or FRUs. Section 11 Replacement Procedures provides guidance for components that are not replaceable by the user. 8.3 Coil Configurations Connect to Connect to Configuration Imaging Connect to Left...

  • Page 43: Fru List With Ge Part Numbers

    9 FRU List with GE Part Numbers FRUs are parts or assemblies that can be replaced if damaged. The following tables list all FRUs that are available for ordering from Sentinelle or GEHC. 9.1 Patient Support FRUs GEHC Part # Sentinelle Part # Part Description Section #...

  • Page 44: Padding Kit Frus

    9.3 Padding Kit FRUs Pads and straps are designed as customer consumable components. They are not intended to GEHC be covered by any GE service contract. If pads and straps are replaced they should be billed to ONLY the customer. GEHC Part # Sentinelle Part # Part Description...

  • Page 45: Fru And Fastener Locations

    FRU and Fastener Locations 10.1 Patient Support FRUs Fasteners Item GEHC FRU # SMI FRU # FRU Description Type 5408248 SVC-00344 Patient Support Cover Contained in 5408246 Contained in Patient Support Cover Catch (2) PHMS Slot 4-40x0.25L Brass Tabletop Spare Parts Kit 4001157-11 Not a FRU –...

  • Page 46: Replacement Procedures

    Replacement Procedures If any BBPs are present, stop work and notify customer that the Vanguard must be cleaned prior to performing service. Most components are direct replacements requiring no tools or training to perform. Replacement procedures are defined for components that should be cleaned, replaced or repaired by the field service technician and require testing after replacement.
  • Page 47 11.2 Table Alignment Tab SMI Part #: SVC-00346 GEHC Part #: 5408250 Time required: 20 minutes Tools required: 5/64” Allen wrench Personnel required: 1. Place Patient Support upside down on a soft/protected surface to access Table Alignment Tab(s). 2. Note position of alignment tab by marking a reference line with a delible writing utensil on the Patient Support.

  • Page 48: Interface Box

    11.3 Interface Box SMI Part #: 4000444-11 GEHC Part #: 5407765-8 Time required: 10 minutes Tools required: none Personnel required: 1. Place Patient Support upside down on a soft/protected surface to access Interface Box. 2. Turn each fastener ¼ turn to loosen. 3.

  • Page 49: Patient Support Cover

    11.4 Patient Support Cover SMI Part #: SVC-00344 GEHC Part #: 5408248 Time required: 20 minutes Tools required: 5/64” Allen wrench Personnel required: 1. Place Patient Support upside down on a soft/protected surface. 2. Remove Interface Box as detailed in section 11.3 Interface Box. 3.

  • Page 50: Patient Support Cover Catch

    11.5 Patient Support Cover Catch SMI Part #: 1659A2 GEHC Part #: Contained in 5408246 Time required: 20 minutes Tools required: Slot Screwdriver Personnel required: 1. Open the Patient Support Cover. 2. Remove the striker from the underside the Patient Support Cover by unfastening two mounting screws.

  • Page 51: Appendix

    Appendix Vanguard Tabletop for GE MR750 and MR750w Installation Verification Checklist Install Date: __ __ __ __ __ 20__ __ M M M Location: ____________________________ , __ __ C I T Y, S T A T E / P R O V I N C E Customer Name: ______________________________________________________________________ Vanguard Serial #:...

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