MAMMOMAT B.brilliant - Biopsy Hardware Overview

SIEMENS Healthineers SIEMENS Healthineers MAMMOMAT B.brilliant ..... . MAMMOMAT B.brilliant Biopsy Hardware Overview Job Aid Template Effective Date: 10 Aug 2021 | HILS 2223 QR700016614 I 02 Jan 2025 Unrestricted I © Siemens Healthineers, 2025 MAMMOMAT B.brilliant Biopsy Hardware Overview Job Aid SIEMENS Healthineers Table of Contents Biopsy unit 3 Acquisition area 5 Automatic movement of the swivel arm 6 Needle holders 8 Compression plates 16 Spacer plate (option) 18 Biopsy tower 19 Handbox 24 2 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy unit SIEMENS Healthineers The Breast biopsy option comprises the biopsy unit with the needle holder/needle positioning device, safety switch, compression plate, and handbox. 1 Indication light 2 Overriding button/Needle positioning device 3 Needle holder 4 Handbox 5 Compression plate 6 Spacer plate For stereo exposures, the swivel arm of MAMMOMAT B.brilliant moves ± 15° on both sides. MAMMOMAT B.brilliant covers an angular range from +25° to -25°. The image acquisition can start from either side for a Tomo Biopsy image: -25° to +25° or +25° to -25°, depending on which projection view you are taking. 25 projection views are acquired in total. These are used for the tomo reconstruction. Please note: Biopsy examinations are possible in the range from -90° to +90°. 3 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy unit SIEMENS Healthineers Attachment 1. Gently slide the biopsy unit onto the object table as far as it will go. It is positioned correctly when you hear a click on each side. ----- 2. Open the plug cover and insert the aligned connector to lock it into place securely. 3. Place the handbox alongside the biopsy unit, e.g., next to the compression unit. or – – Secure the holder for the handbox. 4. Attach the biopsy compression plate. 5. Attach the needle holder and remove it again. 4 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Acquisition area SIEMENS Healthineers Biopsy volumes (with currently available needle holder): • Vertical needle guidance: 50 mm x 40 mm x 100* mm • Horizontal needle guidance: 100 mm x 40 mm x 77* mm The above-stated volumes are maximum values. They may be lower depending on the needle and needle holder selected. Please note: The bottom 5 mm slices are within the safety distance to the object table and can’t be reached. When using the horizontal approach, the safety distance to the detector depends on the selected needle holder and the use of the optional spacer plate. In addition, with the horizontal approach, there is a 5 mm zone directly below the compression paddle where a target cannot be reached. Compression plate Biopsy volume, depending on compression plates Object table *Height of object table 5 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Automatic movement of the swivel arm SIEMENS Healthineers Stereotactic biopsy Following a scout exposure, a stereo pair with 2 exposures at -15° and +15° is taken. The exposure button must be pressed and held during both exposures. Healthineers • Swivel arm moves to -15°, first exposure is taken. MAUNOHAT Bbrilliant • Swivel arm moves to +15°, second exposure is taken. Let go of the exposure release button. Both stereo images are displayed adjacent to each other. On completion of the stereo pair, the tube will remain at the 15° position. 6 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Automatic movement of the swivel arm SIEMENS Healthineers Tomosynthesis biopsy The starting position for a tomosynthesis scan is +30° or -30°, depending on the projection view and system angulation. During the scan, 25 projection images are acquired in an angular range of 50° (±25°). The swivel arm moves to the starting position by either pressing the Ready button on the operation keys or if the Exposure button is pressed. Press the exposure release button on the control box, foot, or hand switch until all projection images have been acquired. • The swivel arm remains in the end position. • The first view and the calculated slices are displayed. 7 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Important information Needle holders are used for biopsy examinations. • Reusable needle/probe guides (bushings) must be sterilized before every examination. Follow the manufacturer's guidance. Plastic needle/probe guides (bushings) must be replaced for each patient. • When performing a vertical biopsy, ensure that there is enough room and that nothing is between the biopsy device and the tube head. Consider the biopsy device's overall length and the needle holder's height (target height). When the biopsy device is attached, the needle holder should not be raised to the highest position. • If a biopsy is performed using the horizontal holder on the biopsy unit, ensure that there is adequate clearance with nothing between the compression paddle and the patient's breast. • If an error message appears while the needle holder moves, continue the procedure with a new scout view. • During a biopsy exam, ensure cables and tubing are not in the field of view. These objects may impact the image processing. 8 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Standard vertical needle holder Standard is used for vertical fine needle and core biopsy. Make sure to use the appropriate needle guides for the selected needle and needle holder in use. The lower part of the vertical standard needle holder can be extended. This offers increased stability for fine needle guidance. Push the lower part of the needle holder downwards to open the extension. You can take the needle holder extension apart for cleaning and disinfection. Upper holder for bushing/needle guide Release button Lower holder for bushing/needle guide (Extendable) 9 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Standard horizontal needle holder The standard horizontal needle holder is mainly used for horizontal needle markings and fine needle biopsies. The package includes two holders to enable access from the left side and the right side. X- offset position button Release button Proximal and distal holder for bushing/needle guide The standard horizontal needle holder has four different X- offset positions: 110mm, 140mm, 170mm and 200mm. The X- offset position should be selected according to the chosen needle length (shorter needle lengths = smaller X- offset position, longer needle lengths = larger X- offset position) to reach the target volume. To change the X- offset position, press the X- offset position button and slide to the desired position. Ensure this locks into place to ensure accuracy of reaching the target with the selected needle. 10 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Dedicated vertical and horizontal needle holders Dedicated needle holders are available as a set, with one vertical and two horizontal approach needle holders for various vacuum biopsy manufacturers (for example, Mammotome Revolve ). TM Needle holder fork to mount adapter plate and biopsy device R Release button Bracket for dedicated bushing/needle guide Horizontal Vertical 11 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Mounting accessories The accessories for mounting a vacuum biopsy device* to the corresponding dedicated needle holder are included in the scope of delivery. This includes an adapter plate, fixing screw, allen key, and allen screw. Allen screw Allen key Opening for the Allen screw Insertion aid (needle holder fork) Fixing Screw Stopper (needle holder fork) Mammotome Revolve 044415 Adapter plate Attachment pins to the counterpart on the biopsy device Third-party product Mammotome Revolve TM 12 *An additional vendor-specific adapter may be required to mount a vacuum biopsy device. QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Attachment accessories (1/2) 1. Attach any required* accessories for the biopsy instrument, such as a dedicated biopsy device adapter plate or fire-forward accessory, including a driver bracket, according to the description in the corresponding instructions for use by the third-party manufacturer. 2. Place the adapter plate so that the pins on the adapter plate fit into the holes provided on the biopsy device. These are located (depending on the manufacturer) either directly on the holster, the specific adapter plate, or the fire-forward accessory. Image of third-party vendor adapter pictured above Please note: The black fixing screw of the adapter plate must point towards the head side of the stereotactic probe. The stopper points towards the needle. 3. Insert the Allen screw into the corresponding opening and tighten it using the Allen key. 4. Attach the dedicated needle holder to the biopsy unit. 5. Attach the needle guide/bushing for the needle used. Please note: At this point, the biopsy examination has started. A target is transferred, and the biopsy unit is in the target position. If necessary, the swivel arm can be moved to a specific side before attaching the biopsy device. *Disclaimer: Only needle holders tested by Siemens Healthineers are to be used. 13 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Attachment accessories (2/2) Inserting the biopsy device: 6. Make sure that the fixing screw of the adapter plate is loosened sufficiently. Now, insert the adapter plate with the insertion aid into the fork of the needle holder. Ensure that the needle is inserted into the bushing/needle guide. Fully insert the needle before starting the biopsy examination. 7. Tighten the fixing screw in the final position. Please note: The needle is in the final position when the adapter plate is pushed into the fork of the needle holder as far as it will go. The fixing screw can be fixed midway to lock the biopsy needle in any position before touching the skin. For example, to inject anesthetics or skin incision. 14 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Needle holders SIEMENS Healthineers Attaching or detaching a needle holder to the biopsy unit The needle holders have a sliding mechanism for mounting. The Acquisition Workstation (AWS) may request a safety check. For that, the needle holder must be attached and removed. After that the biopsy examination can be started. To attach the needle holder, bring the back of the needle holder with the counterpart to the needle positioning part at the biopsy unit. Then, slide it in from top to bottom. If it clicks into place, it is installed correctly. To detach the needle holder, push the release button and slide it upwards. 15 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Compression plates SIEMENS Healthineers Options for biopsy examinations The following compression plates can be used for a biopsy examination: Compression plate for vertical biopsy with Compression plate for horizontal biopsy without window (option). window. The biopsy volume is indicated by the straight lines. A thin line in the plastic tray indicates the Field of View (FoV). 16 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Compression plates SIEMENS Healthineers Detaching/Attaching The plastic trays can be removed from the holder. Push the front edge down and remove the tray. This is shown in the following side view diagram: 2 1 The plastic trays can be attached to the holder. Mount the plastic tray from below 1 and move it upwards 2 . Please note: To avoid defects in the recess, check that the recess of the compression plate is positioned correctly. Do this before each compression. You may have to press the metal sides of the compression paddle frame to ensure a good fit for the paddle insert. 17 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Spacer plate (option) SIEMENS Healthineers The spacer plate is used for biopsy examinations. It can only be used if previously activated in the service menu. The spacer plate for horizontal needle holders: • Can easily be mounted on the biopsy table to raise the breast. Also, the distance between the biopsy table and the compression paddle should be increased. • For horizontal approach, and thin body part- and compression thickness. • Taking the spacer plate into consideration, dose setting, breast thickness, and target volume are calculated. • The breast thickness is the distance between the spacer plate surface and the compression paddle (body part thickness). • The slices are counted and reconstructed from the table (incl. spacer plate). Please note: The spacer plate is recommended to be used for horizontal biopsies with a horizontal needle holder, especially for thinner breasts (breast thickness < 30 mm) or if the lesion is in the lower part of the breast. 18 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers Safety mechanism Indication lamp Overriding buttons Needle holder Needle holder release button There are two states for the safety mechanism: 1. Automatic movement of the needle positioning device is possible  Indication lamp lights up yellow; no needle holder is mounted. 2. Automatic movement of the needle positioning device is not possible  Indication lamp lights up green; a needle holder is mounted. 19 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers Mounting a needle holder Mounting a needle holder: • Slide the needle holder from top to bottom into the connector on the biopsy tower. Slide until the needle holder release button is locked. • To remove the needle holder, press the release button and push the needle holder up. The blocked movement of the needle positioning device is overruled when pressing one of the overriding buttons. • Lamp lights up yellow for as long as you keep the button pressed. • Move the needle holder position by pressing the desired direction button on the handbox simultaneously. 20 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers System behavior (1/2) The system behavior depends on the setting of the safety mechanism and the compression force. No needle holder attached, and compression force < 15 N: • Height adjustment and rotation of the swivel arm with the rotation keys (tube head with detector table) is possible. No needle holder attached, and compression force > 20 N: • Height adjustment is not possible. • Rotation of tube head with rotation keys is possible (tube head and detector are decoupled). • Indication on the display Minimum compression reached (check mark). Needle holder attached: • Height adjustment is not possible. • Rotation of the tube head with rotation keys is possible (tube head and detector are decoupled). • Indication on the display: The system graphic is grey to indicate that the system's height adjustment and rotation are blocked. • When a needle holder is attached, height adjustment is blocked. Tube head rotation with the rotation keys is possible regardless of the compression force. 21 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers System behavior (2/2) Needle Compression Height Rotation of swivel arm Rotation of tube head Display “minimum Indication light holder force adjustment (including object table) (decoupled from compression on biopsy tower/ automatic attached object table) reached” movement possible No < 15 N Yes Yes No No Yellow / yes No > 20 N No No Yes Yes Yellow / yes Yes 0 - 200 N No No Yes Compression Green / no force dependent 22 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers Checking automatic movement The precision of the biopsy examination depends upon the correct accuracy check of the system. This is checked daily by means of a biopsy examination. The accuracy of the biopsy unit is ˂ The biopsy unit must be inspected daily to check the biopsy tower safety mechanism functions correctly when mounted. 1. Mount the biopsy unit. 2. Mount the needle holder. Ensure the indication light glows green. 3. Press any button on the handbox. Ensure that the needle holder does not move. 4. Press one override button and simultaneously any button on the handbox. Ensure the indication light glows yellow and movement is possible. 5. Detach the needle holder. Ensure that the indication light glows yellow. 6. Press a button on the handbox. Ensure the needle holder movement device moves without pressing override buttons. 23 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers Daily accuracy check of the biopsy unit and the needle (1/2) The precision of the biopsy examination depends upon the correct accuracy check of the system. This is checked daily through a biopsy examination in biopsy mode with the biopsy phantom. The accuracy of the biopsy unit is < ± 1 mm. 1. Prepare the system for the biopsy examination. 2. Insert at least one pin in the center position of the biopsy phantom. The aperture on the phantom pin should be parallel to the object table plane. 3. Place the biopsy phantom on the object table, so that the reference mark is visible in the hole in the base plate. 4. Attach and remove the needle holder as directed on the screen to verify the safety mechanism. 5. Move the compression paddle down and compress it enough to fix the phantom. 6. Take a scout exposure. 7. Take a stereo pair if scout exposure is done in stereo mode. 8. Check the reference point(s). 9. Set an accurate target mark in stereo pair or tomo scout (in the center of the pin's metal ring); if necessary, select Zoom From Point or Zoom from Target Mark and click Confirm. 24 Phantom target circle and base plate circle in the image QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Biopsy tower SIEMENS Healthineers Daily accuracy check of the biopsy unit and the needle (2/2) 10. Select the calibration needle on the Acquisition subtask card, if this is not the default needle for the daily accuracy check verification procedure. 11. Select the target mark with the corresponding needle and needle holder. 12. Click Transmit to transmit the target mark to the biopsy unit. The needle positioning part moves to the target position. 13. Attach the needle holder and insert the bushings for the calibration needle. 14. Insert the calibration needle. 15. Check the needle tip position of the calibration needle • The needle tip must be no more than 1 mm from the selected target point. • If the deviation exceeds ±1 mm, please perform a biopsy calibration and repeat the accuracy check. • The needle tip should be within the hole of the phantom. The needle tip must not touch the phantom, go through the hole, or be positioned above it. (2) (1) (2) X (3) 2 mm 1 x (4) 2 mm (3) X ( 5 ) 2 mm (4) (5) 2 mm Incorrect needle positioning Correct needle positioning (1) Top view of phantom and needle (2) Side view of phantom and needle (3) Needle (4) Phantom (5) Phantom hole 25 MAMMOMAT B.brilliant Operator Manual VA10 pp. 217-220 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Handbox SIEMENS Healthineers The handbox is used to control the needle positioning device. Key Function 00 Movement in x direction (x = left/right) 00 Movement in y direction (y = back/forth) G14 Movement in z direction (z = up/down) After the coordinates for a target have been sent to the biopsy unit, the following information is displayed on the handbox: • X - Selected target (maximum 25 targets can be set) • Y - Length of selected needle (as per needle configuration, for example, 106 for 106 mm) • Z - Safety distance, e.g., 5 for 5 mm to the detector cover (vertical) If you touch a button on the handbox, all information disappears, and 0.0.0 is displayed on the handbox. If the needle holder is moved, the distance from the original coordinates will be added, and the final values will be displayed. 26 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 Handbox SIEMENS Healthineers Attachment and handbox holder The handbox holder with the flexible arm to the left and right at the cover of the biopsy unit can be attached. Then, the handbox can be attached to the handbox holder. Please note: Before mounting the handbox and handbox holder, rotate the swivel arm in the desired position for the biopsy procedure. 1. 1 Slide the flexible arm from top to bottom into the corresponding counterpart on the biopsy table. 2. 2 Hang the handbox holder on the corresponding counterpart on the flexible arm. 3. 3 Insert the handbox into the holder from above. 4.4 Connect the cable of the handbox to the plug on the back side of the biopsy unit. 8 88 BRB 1 1 2 2 3 4 27 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025 SIEMENS Healthineers Please note this 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 or third-party vendors. This material is to be used as training only and shall not substitute the Operator Manual. 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 at the time of the training. The Operator Manual shall be used as your main reference, particularly for relevant safety information, such as warnings and cautions, and daily checks to ensure proper functionality. Please note: Some functions 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 prohibited 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. Siemens Healthineers HQ I Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com 28 QR700016614 I 02 Jan 2025 Unrestricted | © Siemens Healthineers AG, 2025