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mammotome REVOLVE - Chapter 4 STEREOTACTIC (ST) INSTRUCTIONS FOR USE; Overview and ST Probe;Holster Description

mammotome REVOLVE
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4-1
Chapter 4 STEREOTACTIC (ST) INSTRUCTIONS FOR USE
Overview
This chapter provides a step-by-step description for collecting tissue samples using the Mammotome revolve Dual
Vacuum-Assisted Biopsy System for a Stereotactic Guided Procedure.
Mammotome revolve ST Probe and ST Holster
Summary Description
The Mammotome revolve ST Probe and ST Holster are used together to perform a stereotactic breast biopsy
procedure.
The holster is a non-sterile, reusable instrument with one electrical cable for transmitting information to the
control module. The holster communicates with the control module and ST probe to drive basic functionality
for the procedure. Buttons on the holster control the functions of the Mammotome revolve Dual Vacuum-
Assisted Biopsy System.
The ST Probe is a sterile, single-patient-use device that may be used with imaging guidance to excise
a tissue sample for diagnosis. The probe is designed to be loaded onto the ST holster. The probe
consists of an outer trocar shaft and an inner cutter in a distal sample aperture. The sample aperture
can be rotated to the desired orientation using either the probe’s aperture rotation thumbwheel or the
ST Holster aperture rotation knobs. The probe comes packaged with an attached vacuum tube set to
connect the probe to a vacuum source. The tube set has three points of attachment: 1) the control
module vacuum connection slot, 2) the vacuum canister port, and 3) a saline bag. For further
convenience, the probe includes a Specimen Management System consisting of 12 proximal
specimen collection chambers. Each collection chamber is designed to capture and hold excised
tissue. The specimen collection chambers are designed to be removed from the fluid management
manifold in two separate trays (of six chambers each). If desired, the tissue can remain in the
chambers to be directly imaged in the post-biopsy specimen radiograph.
NOTE: ST Probe and Holster Illustrations and Nomenclature are described in Chapter 2: System
Description.
ST Holster Button Description
OPEN/CLOSE button. Opens and closes the cutter location in the aperture.
BIOPSY button. Activates the cutter for tissue sampling.
o Press and release for single specimen acquisition.
o Press and hold for continuous sampling.
NOTE: When the BIOPSY button is pressed, the specimen management system first automatically
indexes to the next available chamber to receive the attempted specimen.

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