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SMI-1414-EN Rev. 005 - Installation and Service Manual
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Revision History

Rev

Date

Author

Type

(Major/Minor)

Summary of Changes

16 DEC 2010

L. Mete

Major

Initial Release

003

02 FEB 2011

L. Mete

Major

Updated as per GEHC comments

004

14 FEB 2011

L. Jankowski

Minor

Updated with GEHC HSE comments

005

05 AUG 2011

L. Jankowski

Major

Updated with riser components and new
phantom positioner; header and footer changed
to match user manuals at the request of
Regulatory

Содержание Sentinelle Medical Vanguard

Страница 1: ...stallation and Service Manual Page 1 of 51 Vanguard 16Ch Breast Tabletop Coil for GE 3T MR750 and MR750w Installation and Service Manual Manufactured By Sentinelle Medical a Division of Hologic Distri...

Страница 2: ...2 16 DEC 2010 L Mete Major Initial Release 003 02 FEB 2011 L Mete Major Updated as per GEHC comments 004 14 FEB 2011 L Jankowski Minor Updated with GEHC HSE comments 005 05 AUG 2011 L Jankowski Major...

Страница 3: ...ers held for inspection by the carrier A transportation company will not pay a claim for damage if an inspection is not requested within this 14 day period To file a report with GE Call 1 800 548 3366...

Страница 4: ...en pati nt gewond kunnen raken als gevolg van een elektrische schok mechanische of andere gevaren WARNING EN This service manual is available in English only If a customer s service provider requires...

Страница 5: ...apkopes rokasgr mata ir pieejama tikai ang u valod Ja klienta apkopes sniedz jam nepiecie ama inform cija cit valod klienta pien kums ir nodro in t tulkojumu Neveiciet apr kojuma apkopi bez apkopes ro...

Страница 6: ...mu Zanedbanie tohto upozornenia m e sp sobi zranenie poskytovate a slu ieb obsluhuj cej osoby alebo pacienta elektrick m pr dom mechanick alebo in ohrozenie ATENCION ES Este manual de servicio s lo e...

Страница 7: ...ce Box Installation 21 7 3 Vanguard Installation 22 7 3 1 Patient Support Setup for the GE Discovery 750 System and GE Discover 750w System without GEM Option 22 7 3 2 Patient Support Setup for the GE...

Страница 8: ...em FRUs 43 9 3 Padding Kit FRUs 44 9 4 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 47...

Страница 9: ...tinelle Medical SMI personnel or GE Healthcare GEHC personnel These sections are noted using the following symbols SMI ONLY OR GEHC ONLY GE FE s shall only service systems that were sold by GEHC Coils...

Страница 10: ...king on this product Wear safety shoes for foot protection Wear gloves for hand protection Wear safety glasses for eye protection 3 1 1 Occupational Exposure to Infectious Agents Installing and servic...

Страница 11: ...body fluid 1 Seek immediate medical assistance 2 Advise your supervisor of the exposure event GEHC ONLY If you have previously refused vaccination to Hepatitis B GE must offer the vaccination to you a...

Страница 12: ...te to remind the customer and confirm that the scanner time is booked off and the Vanguard has been delivered to the immediate area of the scanner A copy of the P O or work order for the unit to be in...

Страница 13: ...rvice Pending Applications training immediately following installation An SMI or affiliate service log must be filled out to officially record the installation If any non conformances or problems are...

Страница 14: ...ies Item Box GEHC Part SMI Part Description 1 2 of 2 5408232 4000189 11 Patient Support Assembly 2 2 of 2 5408235 SVC 00319 Shoulder Bridge Qty 2 3 2 of 2 5408236 SVC 00318 Headrest Assembly 4 2 of 2...

Страница 15: ...Interface Box 3T16Ch 2 1 of 2 5407765 6 4000445 11 Medial Array 3T16Ch 3 1 of 2 5407765 4 4000429 11 Lateral Array Right 3T16Ch 4 1 of 2 5407765 5 4000428 11 Lateral Array Left 3T16Ch 5 1 of 2 540776...

Страница 16: ...SVC 00327 Shoulder Bridge Pad Qty 2 4 2 of 2 5408289 SVC 00328 Body Pad 5 2 of 2 5408288 SVC 00309 Wedge Pad 6 2 of 2 5408287 SVC 00308 Headrest Pad 7 2 of 2 In 5408290 Kit SVC 00322 Medial Pad 8 2 of...

Страница 17: ...of 1 5407765 13 SVC 00486 Riser Body Pad 3 1 of 1 5407765 14 SVC 00485 Riser Front Pad Figure 4 6 2Product Identification The system is uniquely identified using the labels below For clarity the label...

Страница 18: ...SMI 1414 EN Rev 005 Installation and Service Manual Page 18 of 51 Figure 6 Interface Box Label Figure 7 Lateral Single Loop Coil Left Label...

Страница 19: ...SMI 1414 EN Rev 005 Installation and Service Manual Page 19 of 51 Figure 8 Lateral Single Loop Coil Right Label Figure 9 Lateral Array Coil Left Label...

Страница 20: ...SMI 1414 EN Rev 005 Installation and Service Manual Page 20 of 51 Figure 10 Lateral Array Coil Right Label Figure 11 Medial Array Coil Label Figure 12 Medial Terminator Plug Label...

Страница 21: ...rs who have purchased the riser kit will have both the standard padding kit and the thicker riser body pad and riser front pad from the riser kit You should segregate the standard body pad and front p...

Страница 22: ...e the riser for the GE Discovery 750w System with GEM Option on the GE Discovery 750 System or GE Discovery 750w System without GEM Option Using the riser on these systems may damage the equipment and...

Страница 23: ...hem together 7 3 3 General System Function and Components The Tabletop is a dedicated breast imaging coil and interventional system for 3 0T GE MRI Systems with P Ports The Tabletop consists of a pati...

Страница 24: ...ay Coil 3 Right Lateral Array Coil Figure 17 Bilateral Imaging Components and Setup Without Padding Component 1 Immobilization Frame 2 Biopsy Grid 3 Contralateral Breast Support 4 Place Right and Left...

Страница 25: ...alateral breast away to improve medial access during unilateral interventional procedures The design of the breast support allows the breast of interest to fall further into the aperture for increased...

Страница 26: ...m ensuring the MR guided needle device can safely be directed into the breast tissue Figure 20 Inserting the Catchment Tray 7 3 4 3 Vanguard Cable Plug in the Vanguard cable Do not scan if the cable i...

Страница 27: ...is loaded on the system prior to installing the Sentinelle coil The Sentinelle protocol will only install if the required conditions are met 2 Check to confirm if the 16Ch Sentinelle table coil is al...

Страница 28: ...protocols under the GE Protocol Library The protocol titled Breast Routine 16Ch Sentinelle must be present as shown in Figure 25 If protocol is not present and the coil CD was just installed one may...

Страница 29: ...Sentinelle Coil Definitions Disc into the default typically upper host DVD drive 7 Open a C Shell from the Service Desktop manager and type the following commands su enter root password mount mnt cdr...

Страница 30: ...il Refer to Section 7 5 GEHC ONLY 3 Complete Product Locator information for serialized components Failure do this may result in failure of your site to receive future FMI s Instructions are below o G...

Страница 31: ...e part of GE s System Phantom Set The instructions below only apply to the Sentinelle Vanguard system Note If bubbles are apparent in the phantom tap the outside of the phantom until these bubbles dis...

Страница 32: ...ical 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 patien...

Страница 33: ...ot 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...

Страница 34: ...en the program finishes the screen capture shown in Figure 29 will display Figure 29 Screen Capture MCQA Tool Finish 8 The MCQA program will display a PASS FAIL indicator for each image SIG_IMG in Fig...

Страница 35: ...07765 6 4000445 11 Test 2 SIG_IMG 5 Right Lateral Array 5407765 4 4000429 11 Test 2 SIG_IMG 6 Right Lateral Array 5407765 4 4000429 11 Test 2 SIG_IMG 7 Right Lateral Array 5407765 4 4000429 11 Test 2...

Страница 36: ...e edge of the patient support as shown in Figure 32 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...

Страница 37: ...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 Whe...

Страница 38: ...he 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...

Страница 39: ...ing configuration is available in section 8 1 Imaging Troubleshooting 7 5 3 Troubleshooting tips 1 Ensure that no patient has been started before beginning the MCQA procedure 2 Landmark the coils befo...

Страница 40: ...ner 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...

Страница 41: ...that the scan locations and any FOV offsets are correct Note When selecting two separate 2D imaging volumes the scan may select the middle slice of the entire set of slices for prescan Ensure the midd...

Страница 42: ...Coil Left Medial Array Coil Lateral Array Coil Right LtBreast SMI Left 1 4 Medial 5 8 Right Inactive 8ch Right Breast Unilateral Lateral Array Coil Left Medial Array Coil Lateral Array Coil Right RtBr...

Страница 43: ...lider Right 6 1 1 5408239 SVC 00307 Compression Plate 6 1 1 5408244 4000197 11 Compression Frame Ass y Right 6 1 1 5408245 4000196 11 Compression Frame Ass y Left 6 1 1 5408251 SVC 00347 Compression R...

Страница 44: ...ad 6 1 3 5408288 SVC 00309 Wedge Pad 6 1 3 5408287 SVC 00308 Headrest Pad 6 1 3 5408290 4001152 51 Padding Kit Table Contained in 5408290 Kit SVC 00322 Medial Pad 6 1 3 Contained in 5408290 Kit SVC 00...

Страница 45: ...PHMS Slot 4 40x0 25L Brass 8 C Not a FRU removal required for Patient Support Cover replacement 1 BHCS 6 32x0 25L Brass 8 D 5408251 SVC 00347 Compression Rail 3 BHCS 10 32x0 75L 8 E 5408250 SVC 00346...

Страница 46: ...require testing after replacement 11 1 Compression Rail SMI Part SVC 00347 GEHC Part 5408251 Time required 20 minutes Tools required 1 8 Allen wrench Personnel required 1 1 Place Patient Support upsi...

Страница 47: ...Note position of alignment tab by marking a reference line with a delible writing utensil on the Patient Support 3 Unscrew and remove the two round head cap screws on alignment tab s and remove alignm...

Страница 48: ...red none Personnel required 1 1 Place Patient Support upside down on a soft protected surface to access Interface Box 2 Turn each fastener turn to loosen 3 Remove Interface Box 4 Mount replacement int...

Страница 49: ...d in section 11 3 Interface Box 3 Remove four screws which fasten each cover mounting bracket using a 5 64 Allen wrench 4 Slide pins shown in green out of mounting holes in cover 5 Remove damaged Pati...

Страница 50: ...Remove the rotary catch and striker and replace with a new rotary catch and striker 5 Partially fasten the rotary catch to the Patient Support with two screws 6 Fasten the striker to the underside th...

Страница 51: ...n scanner console SNR results for all configurations are recorded in the user manual Pre Departure All parts and accessories are present and shortages reported immediately Accessories are neatly group...

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