Hologic Brevera 100 System Bedienungsanleitung Seite 4

Clinical Benefits
The Brevera Breast Biopsy System performs biopsies in a time-efficient manner by combining vacuum-assisted tissue acquisition, real-time imaging
verification and advanced post-biopsy handling in one integrated system. Real time imaging enables visual confirmation of tissue acquisition steps,
allowing physicians to make informed clinical decisions with confidence thereby avoiding repeated biopsy procedures.
Adverse Effects
The following adverse effects could occur or have been reported in association with the use of the Brevera Breast Biopsy system:
• Hematoma
• Perforation
• Blunt Trauma
• Infection
• Tissue Damage
• Pain
• Bleeding
• Inflammation
• Electric Shock
• Radiation Exposure, Unintended
• Foreign Body Reaction
Device Preparation - Firing or Non-firing Device
Biopsy Device Connections
Figure 1: Device Driver Component
Refer to the Brevera User Guide for complete console and device instructions for use.
WARNING: Before use, inspect the protective packaging and needle to verify that neither has been damaged during shipment. If it appears that the
packaging or needle has been compromised, do not use the needle.
WARNING: Do not connect the biopsy needle until the system is powered on and the device driver is homed and ready.
1. Place the sealed packaging for the biopsy needle on the console tray.
2. Peel open the sterile packaging of the biopsy needle.
3. Remove the biopsy needle from the tray, leaving the tubing and the tissue filter in the tray. Make sure the biopsy
needle gears are fully forward, toward the needle tip.
WARNING: To maintain sterility, leave the protective sheath on the tip of the biopsy needle.
4. Hold the biopsy needle in one hand, with the gears facing down and the sheathed needle tip facing to the right. Line up the tab on the biopsy needle
with the notch in the device driver.
WARNING: Do not place fingers on the metal parts of the device driver. These parts can move before a
biopsy needle is installed.
5. Carefully move the biopsy needle straight down, aligning the back of the tab with the back of the notch, until the needle engages with the driver. Do
not drag the biopsy needle across the device driver.
WARNING: Do not place fingers on the device driver when system power is on. Parts can move unexpectedly.
6. Slide the biopsy needle forward (to the right) until it locks into position with a click.
WARNING: Make sure that the biopsy needle is fully latched onto the device driver.
7. Get a saline bag and remove the protective cap. (A 250 cc saline bag is recommended.)
8. Remove the saline tubing from the biopsy needle packaging.
9. Insert the spike into the saline bag.
WARNING: Make sure you use an aseptic technique when spiking the saline bag to prevent contamination.
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Figure 2: Connect the Biopsy Needle to the Device Driver
1. Connection to the biopsy needle
2. Connection point to the biopsy device adapter
(groove on bottom)
3. Device driver cord
4. Release latch for the biopsy device adapter
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