MAMMOMAT B.brilliant Biopsy Turnover Workbook

MAMMOMAT B.brilliant Biopsy Turnover Workbook Women’s Health Mammography Iciandia mendaec toribus, omnihit isquis doloria incit mi, sincilita commolo rercium et qui velectatem sit odi blatur. SIEMENS Restricted Healthineers Introduction 4 System hardware overview 5 Key Hardware Features 6 Calibration (yearly or when daily check fails) 12 Daily check 14 ACR Requirements 17 2D Stereotactic Procedure 18 Vertical tomo biopsy procedure 20 Horizontal tomo biopsy procedure (with tomo pre & post images) 22 Biopsy troubleshooting tips 25 Vertical needle localization procedure (standard holder) 26 Horizontal needle localization procedure 27 Biopsy messages 28 Exercises 30 Restricted Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: 10/09/2024 I QR700013819 Healthineers Page 2 of 31 Contact Information Summary Welcome to Siemens Healthineers! Siemens Healthineers is dedicated to helping you maximize your investment throughout the product life cycle and beyond. We aim to enable you to take technology further, achieve higher profitability, and bring patient care to the next level. Find the information, resources, and tools you need to get the most out of your recent investment and stay up to date. Visit https://new.siemens.com/us/en.html. Clinical Training and Continuing Education Customer Care Center - Clinical Application Support: Call 1-800-888-7436 • Troubleshooting assistance • Immediate assistance for software applications and workflow issues • Please provide the Functional Location Number when calling for assistance. Siemens Training Centers Siemens Clinical Education Training Center – TDC2110 Mac Alyson Court Cary, NC 27511 Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 3 of 31 Introduction You may have already gained an overview of the MAMMOMAT B.brilliant hardware components and user interface while working through the provided online training courses on PEPconnect. To help you prepare for the biopsy training, you can use this workbook to deepen your knowledge about system operation and to be able to perform biopsy exams. Please write your open questions down in the note’s sections provided after each chapter so that a certified education specialist can answer and clarify them during the handover training. Note: Tomosynthesis and the Standard Needle Holder are optional features. The corresponding operator manuals provide detailed information about the features and their workflows. Training overview Upon completion of this workbook, you will be able to: • Power up and activate the biopsy unit • Utilize key hardware features of the biopsy unit • Identify and perform the required QC tests for the unit • Perform a Biopsy Procedure • Perform a Needle Localization Procedure • Correctly power off the unit Training materials Please note that the learning material is for training purposes only! The following instructional material is an excerpt from the operator manual. It is to be used as training material only and is not intended to substitute for the operator manual. For proper use of the MAMMOMAT B.brilliant software or hardware, detailed operating instructions, and relevant safety instructions, such as warnings and cautions, always use the Operator manuals issued by Siemens Healthineers. Any material used in this training will not be updated regularly and does not necessarily reflect the latest version of the software and hardware available during the training. Note: Some functions in this material are optional and might not be part of your system. For quick assistance, please refer to the online help on the Acquisition Workstation (AWS) under Help in the menu bar at the top of the screen. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 4 of 31 System hardware overview (1) (3) ( 4) ( 5 ) 1) Indicator light 2) Overriding button/needle positioning device 3) Needle holder 4) Handbox 5) Compression Plate (3) (2) ( 1) 1) Compression plate 2) Biopsy volume, depending on compression plates 3) Object table Biopsy Volumes: Vertical needle guidance: 50mm x 40mm x 100mm* Horizontal needle guidance: 100mm x 40mm x 77mm* (with currently available needle holder) *Height of object table The bottom 5 mm slices are within the safety distance to the object table and cannot be reached. When approaching horizontally, a range of 5 mm below the paddle height is set as a safety distance and cannot be reached. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 5 of 31 Key Hardware Features Standard Needle Holder • Can be removed for cleaning. • Alcohol-based / cleaners containing hydrogen peroxide products are not permitted. • Press the black button to remove from the biopsy tower. • Must be removed for tomo scout and any other tomo sequence. • For safety checks, the needle holder must be attached and removed if the AWS requests it before a biopsy examination can be started. Dedicated Vertical and Horizontal needle holders (option) for core and vacuum biopsy R Handbox The handbox is used to control the needle positioning device. Movement in x direction Movement in y direction Movement in z direction Key Function Movement in x direction (x = left/right) A A) Movement in y direction (y = back/forth) Movement in z direction (z= up/down) Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 6 of 31 Compression & Spacer Plates 1 3 2) 1. Vertical biopsy approach compression plate: It is removable for cleaning and disinfection and has smooth, rounded edges for patient comfort. 2. Horizontal biopsy approach compression plate: A thin line on the plastic tray indicates the area to be targeted. The tray is removable for cleaning and disinfection, and the edges are smooth and rounded for patient comfort. 3. Spacer plate (purchasable option): Recommended to increase the distance of the breast from the detector for easier access with lateral approach, especially for smaller breasts (breast thickness < 30 mm). Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 7 of 31 Attaching the Biopsy unit 1. Slide the biopsy unit over the detector until it engages (selects) into position. (allow the system to reference, before continuing to the next step approx. 30secs) 2. Insert the biopsy unit plug in the port on the gantry's right side. 3. Verify that the hand box is plugged into the biopsy unit. 4. Attach the biopsy compression paddle and face shield. Biopsy Tower with indication light When the indication light is green, automatic movement of the needle positioning device is NOT possible. When the indicator light is yellow, automatic movement is possible. Removing the Biopsy unit 1. Remove the needle. Move the swivel arm to the side using the Ready button if necessary. 2. Remove the biopsy compression paddle and biopsy face shield. 3. Bring the tube head to zero using the single-touch button. 4. Unplug the biopsy unit cable from the side of the gantry. 5. Press and hold both unlock buttons located on the gray handrails of the biopsy unit. 6. Remove the biopsy unit. 7. Remove the handbox and store. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 8 of 31 Biopsy subtask card Open patient Acquisition Biopsy # Y Z Needle @1 R -1.5 28.6 55.8 New (Fil auto N A Post processing Close patient (1) (2) (3) (4) (5) 1) Transmit the selected target mark 2) Delete the selected target mark 3) Needle Navigator 4) Set reference point 5) Home for needle position at the biopsy unit Biopsy Navigator The Biopsy Navigator is a graphic visualization in a posterior anterior view in which the target markers can be viewed in relation to the selected needle, the detector, the safety margin, the compression plate, and the biopsy volume and is used to check the position of the target in relation to the selected needle and the biopsy volume. 1. The first stereo pair exposures have been taken. 2. Select the Biopsy Navigator icon. k Biopsy Nav gator x Biopsy Navigator (1)- (1) (2) x(10) (2) (3) (3) (4) (9) (4) ( 5 ) (8) (8) (7) (5) (6) PA view PA view Confirm Confirm ·(7) 1) Toggle between Scout Image and Biopsy Navigator 2) Target box: targetable area for selected needle and needle holder 3) Needle 4) Target 5) Safety distance above object table 6) Indication of view 7) Scale in mm. 8) Position in mm. 9) Needle aperture 10) Close button Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 9 of 31 Biopsy icons Icon Definition Icon Definition 100 ) 0º 8 2D Scout CC Tomo Scout Pre-fire tomo + Pre-fire stereo exposure + CC CC pair CC (horizontal approach only) Post-fire tomo Post-fire stereo exposure + CC cc pair CC (horizontal approach only) InSpect Inspect View Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 10 of 31 Force Conversion Chart Force in kilograms (kg) Pounds (Lbs.) Newtons (N) 1 2.2 9.81 2 4.4 19.61 3 6.6 29.42 4 8.8 39.23 5 11 49.03 6 13.2 58.84 15.4 68.65 17.6 78.45 9 19.8 88.26 10 22 98.07 11 24.2 107.87 12 26.4 117.68 13 28.6 127.49 14 30.8 137.29 15 33 147.1 16 35.2 156.91 17 37.4 166.71 18 39.6 176.52 19 41.8 186.33 20 44.1 196.13 Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 11 of 31 Calibration (yearly or when daily check fails) 1. Attach the Biopsy unit. 2. Select Patient > Detector Calibration. 3. Follow on-screen instructions. Open patient Acquisition Calibration Please ensure that no paddle is mounted and the needle is removed from the needle holder. Afterwards press the Move to position button. Move to position Post processing Close patient 4. Select the Move to position button. 5. Attach the standard needle holder and insert the calibration needle. 6. Acquire scan. Do not lift off the exposure button/foot pedal until both images are acquired and the tube returns to the zero position. 7. Follow on-screen instructions. Open patient Acquisition Calibration Please adjust the reference mark with the Ref. Point button if needed, place the target mark to the peak of the calibration needle on the image and press Confirm. Ref. Point Confirm Post processing Close patient 8. Select the Ref. Point button. 9. Right-select the image and select Zoom from the point. Left-select the reference mark in the left image and then the same area on the right image to magnify the reference point. Press the ESC key on the keyboard to deactivate “Zoom from point.” 10. Adjust the reference mark on the right and left image if needed. 11. Select Confirm. 12. Right-select the image and select Home Zoom pan. 13. Right-select the image and select Zoom from the point. Left-select the needle tip in the right and left images to magnify. Press the ESC key to deactivate Zoom from the point. 14. Place a target onto the needle tip in both images and hit confirm. 15. Select Move to position. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 12 of 31 16. Remove the needle and needle holder. OR: override by leaving the calibration needle in place and pushing the override button on the side of the tower. The holder will move to the next calibration position. 17. Proceed similarly for the second and third stereo pair as shown in the calibration window. The reference point won’t be checked again. WH AWS X Calibration has been successfully ended. Please remove the needle from the needleholder if it is still inserted and after that press OK to close the calibration. OK 18. The Calibration Successfully Ended box will appear. 19. Remove the needle and needle holder. 20. Select OK. 21. The holder will go to the Home position. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 13 of 31 Daily check 1. Attach the biopsy unit. 2. Register for Daily Biopsy Check test. 3. In the Procedure dropdown, select Daily Biopsy Check. In the acquisition subtask card, change the IPPG to Daily Test Biopsy. 4. Place pegs into the Biopsy Phantom. 5. Place the phantom on the detector with the reference displayed in the hole of the phantom and compress to immobilize the phantom. DO NOT try to achieve OpComp. 1 2 Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 14 of 31 6. Acquire scout image. Select OK to continue, or New to repeat the exposure. 7. Acquire the scan. Do not release the exposure button. The tube will acquire -15° and +15° stereo images. Once the tube returns to the zero position, you can release the exposure button. 8. Check the reference mark by selecting + Make adjustments as needed and select V to confirm. . 9. To magnify images, right-select on the image and select Zoom from Point. Left-select on the Reference Marks. Press the ESC key to deactivate the “Zoom from Point” tool. 10. Target the circle that is not within the peg. Select to Confirm, a dialog box should appear; Target is out of Biopsy Range. Select OK. This verifies that the system is correctly calculating the safety distance. 11. Drag the cursor to the center target position in the Right and Left images. Select to Confirm. 12. Highlight the target numbers (X, Y, Z in the Biopsy subtask card) and verify that the correct holder (standard) and needle (calibration) are selected. Select to Transmit. 13. A box will appear confirming needle selection. Blue arrows will appear in the Biopsy tab while the tower is moving. Once the tower reaches the target, a flag displays next to the selected target on the AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 15 of 31 14. Attach the standard needle holder and calibration needle. 15. Touch the handbox to zero out. The tip of the needle should not be felt from the bottom of the peg. If an adjustment is needed, push the override button, and adjust the needle by using the handbox. 16. Acquire a stereo pair to confirm needle placement within the peg. 17. Record the values displayed on the AWS and hand box in the appropriate place on the QC form. 18. Remove the needle and holder. The system will return to the home position when the study is closed. Weekly Phantom (optional if not ACR Accredited) 1. Attach the biopsy unit. 2. Register Weekly Phantom test. 3. In the procedure dropdown, choose Biopsy Phantom. 4. Verify OpDose is selected. 5. Compress the stereo phantom. 6. Acquire scout image. (If you are not using the mini stereo phantom, acquire the image in quadrants.) 7. Score the phantom. 8. End the procedure and document on the QC form. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 16 of 31 ACR Requirements Radiologists must comply with ACR guidelines for interpreting mammography studies. Surgeons must review the mammography findings with an MQSA-qualified Radiologist. Radiologist/Surgeon • Initially, three hours of Category 1 CME didactic instruction in stereotactically guided biopsy. • Three supervised stereotactic procedures under a qualified physician. • Completion of a residency or fellowship program that includes instruction in stereotactic breast needle procedures. • ACR requires at least twelve stereotactic-guided biopsies per year for continued competency. • Three hours of Category 1 CME in stereotactically guided breast biopsy every three years is required by ACR. Technologist • Initially, three hours of Category A continuing education units in stereotactic-guided breast biopsy. • Documentation of five hands-on procedures under the guidance of a qualified technologist or a manufacturer’s application specialist. • Participation in at least twelve stereotactic-guided breast biopsies per year. ACR Accreditation for stereotactic biopsy is currently voluntary. Please contact the ACR for full details and any updates or changes. Radiologic Technologist's QC QC Text Description Frequency Localization Accuracy Test Verifies system alignment and performance (procedure varies by Daily before manufacturer and system type) patient exams Darkroom Cleanliness Minimizes artifacts on film images by maintaining the cleanest Daily (NA if digital used) possible conditions in the darkroom 3. Processor Q Ensures consistent performance of the film processor Daily (NA if digital used) 4 Phantom Images Ensures that film density, contrast, uniformity, and image quality of Weekly the X-ray imaging system are optimal Screen Cleanliness (NA if Ensures that cassettes and screens are free of dust and dirt particles Weekly digital used) that may degrade image quality or mimic calcifications 6. Viewboxes and Viewing Ensures that the viewboxes and viewing conditions are optimized and Weekly Conditions (if film used) maintained at optimal Levels Hard-Copy Output Quality (if Ensures that the quality of hard-copy output is consistent over time Monthly N hard-copy produced from and matches the gray scales presented on the CRT monitor digital data) 8. Visual Checklist Ensures that the mammography X-ray system and, if applicable, the Monthly digital imaging system are working properly and that the mechanical rigidity and stability of the system are optimal 9. Analysis of Fixer Retention in Determines the quantity of residual fixer (hypo) in processed film as Quarterly Film (NA if digital used) an indicator of keeping quality 10. Compression Ensures that the X-ray imaging system can provide adequate Semiannually compression in the manual and automatic powered mode 11 Repeat Analysis Determines the number and causes of repeat patient exposures and Semiannually identifies ways to improve efficiency, reduce patient breast dose, and cut costs 12 Screen-Film Contact Ensures that optimum contact is maintained between the screen and Semiannually (NA if digital used) the film in each cassette 13. Darkroom Fog Ensures that darkroom safelights and other light sources inside and Semiannually (NA if digital is used) outside of the darkroom do not fog film 14. Zero Alignment Test Verifies that zero coordinate is accurate Before each (if required by manufacturer) patient 15 Any additional tests required As required by by manufacturer manufacturer Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 17 of 31 2D Stereotactic Procedure 1. Attach the biopsy unit and paddle and register the patient. 2. If the site does not have a mapped stereo procedure, manually select the procedure from the Procedure dropdown. images 0ª ) 4 cc CC CC cc CC 3. Double-select the Scout icon. 4. The message box opens: Is the spacer plate used during the next acquisition? – Select Yes or No. WH AWS Is the spacer plate used during the next acquisition? Yes No 5. Position the patient. 6. Use OpDose. The compression force must display at least 15N on the tube stand. Siemens recommends a compression of 40-50 N during a stereo procedure. 7. Acquire scout image. Select OK if the scout is acceptable. Select New to repeat scout. Images OK New 8. Acquire the stereo pair. 9. Check reference marks by selecting + and adjusting as needed. Select V to Confirm. Note: Reference point will change to a green check mark when selected. 10. Place the target and select to Confirm. 11. Select needle and holder from acquisition subtask card. 12. Highlight the target to be transmitted. Select to Transmit. 13. A box will appear confirming needle selection. Blue arrows will appear in the biopsy tab while the biopsy tower moves. Once the tower reaches the target, a flag is displayed next to the selected target on the AWS. 14. Attach the needle holder. Zero out the handbox by pressing any button on the handbox. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 18 of 31 15. To mount the biopsy device, verify that the needle is in the cocked position. 16. As a precaution, push the override button on the side of the tower and raise the Z coordinate on the Handbox to a safe position until the radiologist is ready to advance the needle in the breast. 17. Lower the biopsy needle close to the skin to indicate where to inject the Lidocaine. Bring the Z and tube back to the zero position. 18. Acquire stereo images. 19. Perform a biopsy and acquire the InSpect image. 20. Deploy the clip per vendor recommendations and acquire clip placement image. 21. Remove the biopsy device and needle holder. 22. Release compression, then remove the patient. When the message below appears, select Yes. WH AWS The compression force changed by more than 15N or dropped below 15N. Sufficient compression for accurate target positioning cannot be ensured Do you want to continue with the current compression phase? Yes No 23. Perform post-procedure 2D imaging. 24. Close the patient at the AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 19 of 31 Vertical tomo biopsy procedure 1. Attach the biopsy unit and paddle. 2. Confirm the Show Virtual Paddle is selected under View > Show Virtual Paddle Hole. Target Box In of 81 mm mm mGy 3. Register the patient. 4. The procedure may not automatically populate from RIS. If needed, manually select it from the Procedure dropdown. 5. Double-select the Tomo Scout icon. (may take a moment to activate). Images CC - ) + + + CC CC . ) + CC CC InSpect L-CC TOMO SC 6. Message box appears, Select Yes or No. WH AWS ? Is the spacer plate used during the next acquisition? Yes No 7. Position the patient. 8. Use OpDose. The compression force must display at least 15N on the tube stand. We recommend compression of 40- 50 N during a stereo procedure. 9. Acquire tomo scout image. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 20 of 31 10. Scroll through the slices to ensure the region of interest for the biopsy examination is included. Virtual Paddle Hole will disappear when the target area is out of range. Select OK when the region of interest for biopsy is within the biopsy volume – or – Select NEW if the region of interest is not completely visible in the slices. Images OK New 11. Check reference marks by selecting + and adjusting as needed. Select V to Confirm. Note: Reference point will change to a green check mark when selected. 12. Mark the biopsy target point in the tomo slices. Select the slice where the lesion is displayed the sharpest. Select Confirm. Note: multiple targets can be made in multiple slices. Select confirm after marking each target. 13. Highlight the target to be transmitted. 14. Verify the needle and needle holder in the acquisition subtask card. Select the biopsy subtask card, select the correct target, and select the Transmit button . 15. A box will appear confirming the needle and needle holder selection. Blue arrows will appear in the biopsy subtask card while the holder moves. Once the holder reaches the target, a flag will be displayed next to the selected target on the AWS. 16. Attach the needle holder. Zero out the hand box by pressing any button on it. 17. To mount the biopsy device, verify needle is in the cocked position. As a precaution, push the Override button on the side of the tower and raise the Z coordinate on the hand box to a safe position until the radiologist is ready to insert. 18. Lower the biopsy needle close to the skin to indicate where to inject the Lidocaine. Bring Z and the tube back to the zero position. 19. Acquire stereo images if needed. Note: if additional targeting needs to be performed, a new Tomo scout cannot be performed unless the holder is removed, and the tower is in the HOME position. To go to the HOME position, select Otherwise, any new . targets can only be made on the stereo pair. 20. Perform a biopsy and acquire the InSpect image. 21. Deploy the clip per vendor recommendations and acquire clip placement image. 22. Remove the biopsy device and remove the needle holder. 23. Release compression and remove the patient. When the message below appears, select YES. WH AWS The compression force changed by more than 15N or dropped below 15N. Sufficient compression for accurate target positioning cannot be ensured. Do you want to continue with the current compression phase? Yes No 24. Perform post-procedure 2D imaging. 25. Close patient on AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 21 of 31 Horizontal tomo biopsy procedure (with tomo pre & post images) 1. Attach the biopsy unit and paddle. 2. Confirm the Show Virtual Paddle is selected under View > Show Virtual Paddle Hole. Target Box in of 81 mm mm mGy 3. Register patient. 4. The procedure may not automatically populate from RIS. If needed, manually select it from the Procedure dropdown. 5. Double-select the Tomo Scout icon(may take a moment to activate). Images CC + CC + CC InSpect 6. The message box will appear. Select Yes or No. WH AWS ? Is the spacer plate used during the next acquisition? Yes No 7. Position the patient. 8. Use OpDose. The compression force must display at least 15N on the tube stand. We recommend compression of 40- 50 N during a stereo procedure. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 22 of 31 9. Acquire tomo scout image. 10. Scroll through the slices to ensure the region of interest for the biopsy examination is included. Virtual Paddle Hole will disappear when the target area is out of range. 11. Select OK when the region of interest for biopsy is within the biopsy volume. or – – Select NEW if the region of interest is not completely visible in the slices. Images OK New 12. Check reference marks by selecting + and adjusting as needed. Select to Confirm. Note: Reference point will change to a green check mark when selected. 13. Mark the biopsy target point in the tomo slices. Choose the slice where the lesion is displayed the sharpest. Select Confirm. Note: Multiple targets can be made in multiple slices. Select confirm after marking each target. 14. Highlight the target to be transmitted. 15. Verify the needle and needle holder in the acquisition subtask card. Then, select the biopsy subtask card, select the correct target, and select the Transmit button . 16. A box will appear confirming the needle and needle holder selection. Blue arrows will appear in the biopsy subtask card while the tower is moving. Once the tower reaches the target, a flag will be displayed next to the selected target on the AWS. 17. Attach the needle holder. Zero out the hand box by pressing any button on the hand box. 18. To mount the biopsy device, verify needle is in the cocked position. As a precaution, push the Override button on the side of the tower and adjust the X coordinate on the hand box to a safe position until the radiologist is ready to insert. 19. Lower the biopsy needle close to the skin to indicate where to inject the Lidocaine. Bring X and tube back to the zero position. 20. Acquire tomo pre-fire and tomo post-fire images if needed. Note: if additional targeting needs to be performed, a new Tomo scout cannot be performed unless the holder is removed, and the tower is in the HOME position. To go to the HOME position, select Otherwise, any new . targets can only be made on the stereo pair. 21. Perform a biopsy and acquire the InSpect image. 22. Deploy the clip per vendor recommendations and acquire clip placement image. 23. Remove the biopsy device and remove the needle holder. 24. Release compression and remove the patient. When the message below appears, select YES. WH AWS The compression force changed by more than 15N or dropped below 15N. Sufficient compression for accurate target positioning cannot be ensured. Do you want to continue with the current compression phase? Yes No Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 23 of 31 25. Perform post-procedure 2D imaging. 26. Close patient on AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 24 of 31 Biopsy troubleshooting tips Troubleshooting Tips Question / Scenario Solution Make sure your area of concern is in the middle of the If you change the needle, the target box size will change. target box window, not close to the edge. (Acquisition tab to change needle) Note: the area could be outside of the box after this change. How do you know what needle you are using? The needle name is displayed in the patient information area at the bottom of the screen. Can you target if the Target Box is not visible? No Can you do an InExam Image Send in biopsy? No If you select Spacer Plate in use accidentally or decide not Before taking the scout > Acquisition subtask card. to use it, can you change it and where. After taking the scout > A new scout must be taken with the correct answer to the spacer plate message. If you acquire and accept the scout, can you deactivate the spacer plate? No If you take the scout and select NEW, are you asked again for the spacer plate? Yes, every time a new scout is activated How do you know if a specific slice can be targeted during a If the Show Virtual Paddle Hole is checked, a white target tomo biopsy? box will appear on the targetable slices. How do you show the radiologist that the spacer plate was Display the image in the Viewing tab, or they can see it if used? they have an image comment activated in their PACS. Why does the target turn red? Target is not available for transmission with the current needle selection. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 25 of 31 Vertical needle localization procedure (standard holder) 1. Attach the biopsy unit and paddle. 2. Register the patient. 3. The procedure may not automatically populate from RIS. To manually select the procedure, select it from the Procedure dropdown menu and select the correct procedure. 4. Double-select the Scout icon. 5. Position the patient. 6. Use OpDose. The compression force must display at least 15N on the tube stand. 7. Acquire scout image. Select OK if the scout is acceptable. Select NEW to repeat scout. 8. Acquire stereo pair. 9. Check reference marks by selecting + and adjusting as needed. Select V to Confirm. Note: Reference point will change to a green check mark when selected. 10. Place the target and select to Confirm. 11. Select the needle and holder from the acquisition subtask card. 12. Highlight the target to be transmitted. Select to Transmit. 13. A box will appear confirming needle selection. Blue arrows will appear in the biopsy tab while the biopsy tower moves. Once the tower reaches the target, a flag is displayed next to the selected target on the AWS. 14. Attach the Standard Needle Holder. Insert bushings. 15. Inject Lidocaine if desired, insert the needle. 16. Acquire a stereo pair and adjust the Z value in the vertical approach if needed. 17. Deploy the wire and remove the needle. Another stereo pair can be taken for confirmation. 18. Slip the wire out of the bushings. 19. Press the Override button. Manually raise the Z on the handbox. 20. Release compression, remove patient. 21. Close patient on the AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 26 of 31 Horizontal needle localization procedure (purchasable R and L standard lateral holders) 1. Attach the biopsy unit and paddle. 2. Register the patient. 3. The procedure may not automatically populate from RIS. To manually select the procedure, select it from the Procedure dropdown menu and select the correct procedure. 4. Double-select the Scout icon. 5. Position the patient. 6. Use OpDose. The compression force must display at least 15N on the tube stand. 7. Acquire scout image. Select OK if the scout is acceptable. Select NEW to repeat scout. 8. Acquire a stereo pair. 9. Check reference marks by selecting + and adjusting as needed. Select to Confirm. Note: Reference point will change to a green check mark when selected. 10. Place the target and select to Confirm. 11. Select the needle and holder from the acquisition subtask card. 12. Highlight the target to be transmitted. Select to Transmit. 13. A box will appear confirming needle and holder selection. Blue arrows will appear in the biopsy tab while the biopsy tower moves. Once the holder reaches the target, a flag is displayed next to the selected target on the AWS. 14. Attach the appropriate (Right or Left) Standard Lateral Needle Holder. Insert bushings. Note: Manually adjust the needle guide to the correct position (e.g., 110, 140, 170, 200) to match the AWS. 15. Inject Lidocaine if desired, insert needle. 16. Acquire a stereo pair and adjust the X value in the vertical approach if needed. 17. Deploy the wire and remove the needle. Another stereo pair can be taken for confirmation. 18. Slip the wire out of the bushings. 19. Press the Override button. Manually raise the Z. 20. Release compression, remove patient. 21. Close patient on the AWS. Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 27 of 31 Biopsy messages If the compression changes by more than 15N, this message window indicates that the targeting may have changed. Select Yes to continue the examination or select No to interrupt the examination. WH AWS ? The compression force changed by 26N. Be aware that this may influence the biopsy accuracy. Do you want to continue the stereo examination? Yes No If the compression force drops below 15 N, the following message appears. It is recommended to compress until at least 15 N is achieved. The table movement is blocked when the checkmark for minimum compression reached is displayed on the stand display. WH AWS The compression force changed by more than 15N or dropped below 15N. Sufficient compression for accurate target positioning cannot be ensured. Do you want to continue with the current compression phase? Yes No Note: A warning appears if the swivel arm is moved to an angle ≥ 65°. Please make sure that no body parts may be pinched or crushed. WH AWS To perform stereotactic biopsy, ensure that there is no risk of collision within the tube arm swivel range - tube head will traverse a range of +/- 15º OK With vertical core and vacuum core needles, there may be instances when the target point cannot be exactly in the center of the aperture. This may be due to needle dimensions and the safety distance. Up to a certain point, the planned target can still be achieved off-center in the aperture. The following message window appears. Select Yes if you want to proceed. The target is selected with this needle, off- center in the aperture. If necessary, you can lower the needle down a few mm with the handbox to position the target point closer to the center of the aperture. VH AWS ? The specified target cannot be taken at the middle of the aperture of the selected core needle, but it can be reached within the aperture area. Do you want to proceed with this needle? Yes No Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 28 of 31 If the target point is located near the upper skin border and transmitted, one of the following message windows appear: 1. If the object thickness allows, the needle can be lowered to reach the target off-center of the aperture by max 25%, one of the following messages appears: WH AWS X The identified target is located close to the skin line. The target can be reached with the middle of the aperture, however a part of the aperture might jut out the skin line. Press 'Yes' if you want to proceed with the target in the middle of the aperture while the upper edge of the aperture is out of the skin line. Press 'No' if you want to proceed with the target at the upper edge of the aperture (the needle will be inserted deeper with an automatic adjustment). Press 'Cancel' if you want to select another needle or target. Yes No Cancel Select Yes if you want to proceed with the target in the middle of the aperture. However, part of the aperture may be out of the skin line. Select No if you want to proceed with the target at the distal edge of the aperture and insert the needle deeper, depending on the needle configuration. Select Cancel if you want to select a different needle (smaller aperture, half notch, or different approach). 2. If the object thickness does not allow you to lower the needle, the following message appears since the needle tip would be deeper than the safety distance allows. Select Yes if you want to proceed with the target in the middle of the aperture; however, part of the aperture may be outside the skin line. Select Cancel if you want to select a different needle. (smaller aperture, half notch, or different approach) WH AWS The identified target is located close to the skin line. The target can be reached with the middle of the aperture, however a part of the aperture might jut out the skin line. Press 'Yes' if you want to proceed with the target in the middle of the aperture while the upper edge of the aperture is out of the skin line. Press 'No' if you want to select another needle or target. Yes No Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 29 of 31 Exercises Vertical 2D CC biopsy Vertical 3D CC biopsy Horizontal 2D CC biopsy Horizontal 3D CC biopsy Vertical 3D Lateral (LM) biopsy Horizontal 2D From Below (FB) biopsy (patient is supine, the system is in the 0° (CC) position) Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 30 of 31 Please note that the learning material is for training purposes only! For the proper use of the software or hardware, please always use the Operator manual or Instructions for Use (hereinafter collectively “Operator manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, for relevant safety information like warnings and cautions. Note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Copyright © Siemens Healthineers AG 2024 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com Unrestricted | Published by Siemens Healthineers AG, 2024 © SIEMENS Master Template Effective Date: 5 Mar 2020 | HOOD05162003074494 Job Aid Effective Date: Healthineers Restricted Page 31 of 31