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Table of Contents Grid-Based Approach Positioning the Breast 1 Fiducial Placement 2 Target Correlation 3 The Biopsy: Localization and Sampling Marker Placement and Procedure Completion Verifying VisiLoc™ Position 9 Attaching the Probe 10 Depth Registration 4 Prepping the Breast surface 5 Trocar Preparation 6 Locking the Block 7 Securing the Cannula 8 Sampling Program Applicator Placement 13 Marker Deployment 14 Cavity Verification 15 Introducer Specifications 16

Positioning The Breast Fiducial Placement Target Correlation Depth Registration

Positioning the Breast Position breast within the well of the coil to ensure optimal access to the lesion from the surface of the grid. Advance the grids and/or stabilization plates uniformly until a “pillowing” of the tissue is visible between the fenestrations of the grids

Place an external fiducial marker within a free fenestration of the grid as an external reference point for targeting—ideally away from the suspected ROI but near the breast tissue. Scan the patient pre and post contrast and identify the target ROI seen on the diagnostic MRI Pre Post Fiducial Placement 2

Correlate the position of the ROI within the breast relative to the fiducial on the surface of the breast contained within the grid. Using the MRI Grid Worksheet, determine and note the block location as well as the aperture position within the block that correlates to the ROI. Target Correlation

=10mm Calculate the depth of the targeted ROI by subtracting the actual position of the sagittal slice on which the lesion is identified from the slice in which the surface of the breast is seen. Advance the depth stop to the proper location on the cannula and be sure to add 2cm to the calculated depth to account for the thickness of the block. Depth Registration 4

Prepping The Breast Surface Trocar Preparation Locking The Block Securing The Cannula Verifying VisiLoc ™ Position Attaching The Probe Sampling

Prepping the Breast Surface Sterilize the appropriate area of the breast in and around the fenestration of the projected approach. Anesthetize along the entire projected approach pathway and ~2cm beyond the ROI. Utilize an MRI approved scalpel to make a skin nick at the appropriate location (as noted on the MRI Grid Worksheet). 5

Insert the trocar through the cannula. Slide the trocar and cannula through the appropriate aperture of the block. Trocar Preparation 6

Orient the block to the appropriate position as defined by your MRI Grid Worksheet or CAD software. Insert the tip of the trocar into the skin nick and seat the block firmly into place in the grid without advancing the trocar. Lock the block into the grid fenestration by rotating the lever into the locked position, denoted by the “L” on the block. Locking the Block 7 L

While holding the cannula hub, gently twist the trocar and cannula together while inserting to the desired depth. Lock the cannula into place by rotating the depth stop clockwise until it seats firmly into position. Securing the Cannula 8

2 3 Remove the trocar and insert the VisiLoc obturator into the cannula and fully advance until the handle is flush against the cannula hub. Re- image the patient. The VisiLoc obturator will provide a bright disc in the sagittal plane image and a bright line in the axial plane image. Verifying VisiLoc Position 9 Sagittal Axial

Attaching the Probe Upon confirmation of targeting, attach the EnCor MRI probe onto the EnCor MRI Driver by sliding the front of the probe beneath both of the leading edge guides and snapping the rear of the probe into place. Press the sample button on either the foot-pedal or the driver to calibrate the probe prior to sampling. NOTE: Prior to loading an EnCor MRI Probe, rotate collection chamber 180°. 10

Sampling 2 3 Remove the obturator and insert the probe into the cannula, advancing until it rests flush against the hub. Pre-programmed sampling options available in the EnCor Control Module allow for selecting a sampling pattern to best suit each study. 11

Sampling While the collection chamber remains sealed at all times during tissue acquisition, the tray can be removed for close inspection of samples. Samples accumulate within the collection chamber at the back of the probe. With the tray in place, this provides a truly closed system. 12

Applicator Placement Marker Deployment Position Verification Introducer Specifications

Applicator Placement Upon completion of sampling, carefully remove the probe from the cannula. Outside of the MRI suite, prepare samples for pathology. Insert the SenoMark™ UltraCor® MRI marker applicator into the cannula and advance until the adapter seats firmly into place within the hub. 13

Marker Deployment st 2 nd Unlock the plunger by rotating 90°. Fully advance the plunger in a uniform motion to deploy the marker within the biopsy cavity. SenoMark UltraCor markers are designed to deploy pellets to help ensure that the metal marker remains centered within the biopsy cavity. 14

Position Verification ~1c m Remove the marker applicator and re-insert the obturator into the cannula leaving about 1 cm extending from the hub to prevent disturbance of the marker in the cavity. Re-image. SenoMark UltraCor markers initially provide visibility for all modalities – MRI, stereotactic and ultrasound. 15

Introducer Specifications 16 Item Description10G7G Depth Beyond Obturator Tip Trocar17mm 18mm Blunt Tip Probe15mm N/A Trocar Tip Probe20mm 21mm Sampling Notch Length Full Sample19mm 19mm Half Sample9.5mm 9.5mm Block Depth2 cm 2cm VisiLoc Obturator Trocar Blunt Tip Probe Sampling Notch Block Depth Trocar Tip Probe Half Sample Depth Beyond Obturator Tip

Rx Only Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and directions for use. SenoMark and VisiLoc are trademarks of SenoRx. EnCor and UltraCor are a registered trademarks of SenoRx. ©Copyright 2009 SenoRx ®, Inc. All rights reserved.

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