User's Instructions

6-1
Chapter 6 EX 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 an EX Ultrasound Guided Procedure.
Mammotome revolve EX Probe and EX Holster
Summary Description
The Mammotome revolve EX Probe and EX Holster are used together to perform an ultrasound-guided breast
biopsy procedure.
• The EX 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 EX probe to drive the basic
functionality for the procedure. Buttons on the holster control the functions of the Mammotome revolve Dual
Vacuum-Assisted Biopsy System.
• The EX Probe (with its integrated components) is a sterile, single-patient-use device that may be used
with imaging guidance to excise (a) tissue sample(s). The probe is designed to be loaded onto the EX
holster. The probe consists of an outer trocar shaft and an inner cutter in a distal sample aperture. The
sample aperture can be manually rotated by using the wrist to rotate the probe/holster assembly to the
desired orientation. 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 four (4) proximal specimen collection
chambers. Three (3) collection chambers are designed to capture and hold the excised tissue of a
25 mm lesion (approximate). One (1) chamber is designed to hold a single piece of excised tissue for
removal and examination. The specimen collection chambers are designed to be removed from the
fluid management manifold.
NOTE: Only the Mammotome revolve probes with the letters “EX” in the product code should be used
with the Mammotome revolve EX Holster.
NOTE: EX Probe, Sleeve, and Holster Illustrations and Nomenclature are described in Chapter 2:
System Description.