Contraindications - Hologic Atec Gebrauchsanweisung

ATEC Introducer Localization System
®
Instructions for Use
Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical
consequences.
Important: This package insert is designed to provide Instructions for Use of the ATEC Introducer
Localization System. It is not a reference to surgical techniques.
Patient Target Group
The target patient population of ATEC Breast Biopsy and Excision System includes patients undergoing
breast tissue removal for diagnostic sampling of breast abnormalities.
Indications
The ATEC Introducer Localization System (ILS) is intended to be used as an aspiration needle and/or as an
introducer with another biopsy needle in percutaneous biopsies of the breast for diagnostic purposes only.

Contraindications

When performing biopsies in conjunction with the ATEC Introducer Localization System (ILS) sound
professional judgement should be used on patients who are using anticoagulant therapy and/or patients with
known hemophilia problems.
Device Description
The ATEC ILS is a sterile, single use system of devices comprised of
an introducer stylet, introducer sheath, needle guide and localizing
obturator. The ATEC ILS is intended for use with the ATEC Breast
Biopsy and Excision System when performing vacuum assisted
breast biopsies.
Magnetic resonance imaging (MRI) procedures should be performed
according to the following guidelines.
Intended user
The ATEC Breast Biopsy and Excision System should be used only
by physicians trained in open or percutaneous biopsy procedures.
Expected Clinical Benefit
The ATEC Breast Biopsy and Excision System enables physicians to
use a minimally invasive system to extract small biopsy samples of potentially malignant breast tissue.
Instructions for Use
1. Standard aseptic patient preparation should be employed prior to use of the ATEC ILS.
2. Prior to use of the ILS, inspect the protective packaging and device to verify that neither has been
damaged during shipment. If it appears the packaging has been compromised, do not use the device.
3. Insert the introducer stylet into the introducer sheath. Position the depth stop on the introducer sheath
at the appropriate location according to the pre-determined "Z" value.
4. A standard protocol should be employed to anesthetize the patient and the biopsy site.
5. Insert the sterile needle guide into the compression grid at the identified target area.
6. Insert the introducer sheath/introducer stylet assembly into and through the needle guide to the depth
stop. Rotate the sheath/stylet assembly while advancing. This will create access to the target area.
7. Remove the introducer stylet from the introducer sheath while leaving the introducer sheath in place.
Insert the localizing obturator into the introducer sheath. Move the patient into the imaging field and
image to confirm target accuracy.
Note 1: The usable length of the localizing obturator is equal to the distance from the hub of the ATEC
handpiece to the middle of the sampling aperture.
Note 2: The localizing obturator shows up as a "black dot" on the image screen in the sagittal view and
as a "black line" in the axial view and provides identification, localization and confirmation of the target
area.
8. Move the patient out of the imaging field and remove the localizing obturator. Insert the ATEC handpiece
through the introducer sheath to the biopsy site in preparation for the biopsy to be performed.
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