Warnings And Precautions - Hologic Brevera Gebrauchsanleitung

Warnings and Precautions

• Use caution when attaching sharp devices to the adapter.
• As with any medical procedure, make sure that users wear appropriate personal protective equipment to guard
against potential contact with bodily fluids.
• The Brevera biopsy needle procedure should be performed only by persons with sufficient training and
familiarity with this procedure. Consult medical literature relative to techniques, complications, and hazards
before performing any minimally invasive procedure.
• The Brevera biopsy needle should only be used by physicians trained in percutaneous biopsy procedures.
• Caution: Federal law restricts this biopsy needle to sale by or on the order of a physician.
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• Use sound professional judgment when using the Brevera breast biopsy device on patients with breast implants.
• Avoid operator or instrument contact with the sheathed needle part of the Brevera biopsy needle.
• Minimally invasive instruments and accessories manufactured or distributed by companies not authorized
by Hologic may not be compatible with the Brevera breast biopsy system. Use of such products can lead to
unanticipated results and possible injury to the user or patient.
• Instruments or devices that come into contact with bodily fluids can require special disposal handling to prevent
biological contamination.
• Dispose of all opened disposable instruments whether used or not.
• Do not resterilize or reuse the Brevera biopsy needle or the introducer. Resterilization or reuse can compromise
the integrity of the instrument. This can lead to potential risks of failure of the biopsy needle to perform as
intended or to cross-contamination associated with using inadequately cleaned and sterilized devices.
• A complete and comprehensive preoperative medical history and physical examination are suggested.
Radiographic evaluation and laboratory tests may be included.
• The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and
there may be concern for reproductive and developmental effects.
• The Brevera breast biopsy system with CorLumina imaging technology is not for use with MRI or Ultrasound.
Brevera Biopsy Needle is compatible with the following systems and accessories:
Catalog Number
BREV100
BREV200
BREVDRV
BREVTF01
BREVTF12
EVIVA_NG09L
SMark-Eviva-13
SMark-Eviva-2S-13
SMark-E13-ss1
SMark-E13-ss2
SMark-E13-ss3
TriMark-Eviva-13
TriMark-Eviva-2S-13
English
Description
Brevera 100 System
Brevera 200 System
Driver
Single Chamber Tissue Filter
12 Chamber Tissure Filter
Needle Guide
Titanium Biopsy Site Marker
Titanium Biopsy Site Marker
Stainless Steel Biopsy Site Marker
Stainless Steel Biopsy Site Marker
Stainless Steel Biopsy Site Marker
Titanium Biopsy Site Marker
Titanium Biopsy Site Marker
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