Device Description - Devicor Mammotome elite Manual Del Usuario

Indications
The Mammotome® elite Biopsy System is indicated to obtain imaged or palpated tissue samples from the breast or axillary
lymph nodes for diagnostic analysis of breast abnormalities.
• The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial or
complete removal of the imaged abnormality.
• The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial
removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance
of these abnormalities. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does
not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not
histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard
surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/
or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome® elite Biopsy System may also be used
to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the
standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be
examined for completeness of removal using standard surgical procedures.
Contraindications
• This instrument is for diagnostic use only and is not indicated for therapeutic use.
• This instrument is contraindicated for those patients where increased risk or complications may be associated with core
removal or biopsy based upon the physician's judgment. Patients receiving anticoagulant therapy or who may have
bleeding disorders may be at increased risk.

Device Description

Devicor's Mammotome® elite Biopsy System is composed of a Holster and a Probe. The Mammotome® elite system may be
used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. The
components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a
biopsy procedure.
The Holster, reusable and supplied non-sterile, is a self-contained, handheld, electro-mechanical vacuum-assisted biopsy
device that consists of a rechargeable lithium-polymer battery and includes a charging base with an AC power cord and
adapters (See Figure 1).
The Probe, single use and supplied sterile, includes an outer trocar shaft with distal aperture and a translating inner hollow
cutter (See Figure 2). The Probe also includes an Integrated Coaxial Cannula, and a proximal Specimen Collection Cup with
an enclosed Tissue Sample Basket and cap (See Illustration 2). The body of the Probe contains one Alignment Tab and two
Locking Tabs to secure the Probe into the Holster.
The Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter
rotates at high speeds and advances across the aperture to acquire targeted tissue. The tissue sample is transported by
vacuum to the Specimen Collection Cup. The Integrated Coaxial Cannula may be detached from the Probe after the biopsy
and remain in the breast to retain a track to the biopsy site when placing a biopsy site identifier. The Holster is designed with
3 biopsy button options to accommodate multiple hand positions (See Figure 3).
IMPORTANT:
The 14 GA CorMARK™ biopsy site identifiers may be used in conjunction with the Mammotome® elite Biopsy
System to radiographically mark the location of the biopsy procedure. DO NOT USE A MARKER NOT APPROVED FOR USE IN
THE Mammotome® ELITE BIOPSY SYSTEM.
Figure 1
2