User's Instructions

2-1
Chapter 2 SYSTEM DESCRIPTION
All information in this guide applies to ST, U/S, and EX modalities, unless otherwise stated.
Overview—System Description
The Mammotome revolve Dual Vacuum-Assisted Biopsy System allows the user to sample breast tissue that has
been identified as suspicious under imaging guidance. Multiple tissue samples can be taken without removing the
needle. The user may identify the tissue as it is collected to correspond with the imaging display.
The Mammotome revolve Dual Vacuum-Assisted Biopsy System comprises three primary subsystems:
1. Control Module: a reusable control module, containing the vacuum pump, power supply, valve
actuators, user touchscreen interface, and control electronics.
2. Holster: a reusable holster, containing the drive motors, gear trains, and user activation buttons.
3. Probe: a disposable single-patient use probe, containing the biopsy needle, specimen management
system, and vacuum tube set.
In addition, several optional reusable detachable components are available including a transport cart, remote
footswitch, and remote keypad controls. Disposable detachable components required include a vacuum canister
(ST, U/S, and EX), probe guides (ST only) and a probe and holster holder (EX only). A disposable Holster
Sleeve (EX only) for single-patient use, provided with a packaged EX Probe, is intended to provide a barrier
between the user’s gloved hand and reusable Holster.
NOTE: The usable volume of the canister is 800cc.
Fluids can be delivered through the Mammotome revolve probe for managing selected patient/procedure
requirements.
Biopsy site identifiers may be used in conjunction with the ST and U/S probes to radiographically mark the
location of the biopsy procedure. In the event of removal of evidence of the abnormality, it is strongly
recommended that a biopsy site identifier or other marking device be placed to mark the biopsy site (in case
follow-up is required).
NOTE: Biopsy site identifiers are not intended to be placed through the EX probe. Alternative methods should be
used if placement of a biopsy site identifier is required.
NOTE: Refer to the Biopsy Site Identifier Instructions for Use for compatibility, confirmed fit, function, and length
with the Mammotome revolve Dual Vacuum-Assisted Biopsy System.