Hologic Brevera 100 System Bedienungsanleitung Seite 5

10. Place the saline bag on the saline bag hook on the left side of the console.
11. Route the saline tubing from the spike through the saline tubing notch, counterclockwise around the saline tubing management plate, and through the
saline tubing conduit.
12. Insert the larger diameter section of the saline tubing into the saline pinch valve. Make sure the saline tubing is fully seated.
13. Insert the vacuum tubing into the guide at the top of the saline tubing management plate.
WARNING: Make sure the needle guide is installed correctly before use.
Installing and Removing the Tissue Filter Cap
A. To install, gently lower the tissue filter cap onto the tissue filter until the two tabs snap into place.
WARNING: Make sure that the protrusions in the center of the tissue filter cap align with the grooves on the tissue filter spindle. Make sure both tabs
are fully latched.
B. To remove, pinch the two tabs on the tissue filter cap and pull the cap up.
Performing a Biopsy and Concluding the Procedure
Refer to the Brevera User Guide for complete console and device instructions for use.
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.
ONLY
• 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 Brevera breast biopsy system with CorLumina imaging technology is not for use with MRI or Ultrasound.
• One or more components of this device contain substances defined as Carcinogenic, Mutagenic and Reproductive Toxin (CMR 1A and/or CMR 1B) and/
or endocrine disrupting in a concentration above 0.1% weight by weight. However, the biological risk has been assessed and the product remains safe.
More information on CMR substances is available on the European Chemicals Agency website: https://echa.europa.eu/
Figure 3: Placement of the Saline Tubing in the Saline Pinch Valve
Figure 4: Installing and Removing the Tissue Filter Cap
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