Contraindications; Device Description - Hologic Atec Gebrauchsanweisung

ATEC Ultrasound Introducer
®
Instructions for Use
Please read all information carefully. Failure to properly follow
the instructions may lead to unintended consequences.
Important: This package insert is designed to provide
instructions for use (IFU) for the ATEC
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 ultrasound introducer is indicated 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

Sound professional judgement should be used used when
performing biopsies on patients who are using anticoagulant
therapy and/or patients with known hemophilia problems.

Device Description

The ATEC ultrasound introducer is for use in conjunction with the
ATEC Breast Biopsy and Excision System to obtain percutaneous
core biopsy samples from soft tissue. The ATEC ultrasound
introducer is designed specifically for use with the 9cm and
12cm length, 20mm aperture ATEC breast biopsy devices. The
ATEC ultrasound introducer is a sterile single-use system of
devices comprised of a stylet with an echogenic aperture and
introducer. The ATEC ultrasound introducer provides single
insertion access to the targeted area of interest and assists in
deploying the appropriate biopsy site marker.
Intended user
The ATEC Breast Biopsy and Excision System should be used
only by physicians trained in open or percutaneous biopsy
procedures.
Device Preparation
(All steps to be performed per standard interventional technique)
1. Standard aseptic patient preparation should be employed prior
to the use of the ATEC ultrasound introducer.
2. Prior to use of the ATEC ultrasound introducer, inspect the
packaging and device to verify that neither has been damaged
during shipment. If it appears that the packaging has been
compromised, do not use the device.
3. Carefully remove the ATEC ultrasound introducer from its
protective packaging and remove its protective sheath.
4. If a 9cm ATEC ultrasound introducer is being used with a
CeleroMark,SecurMark for Celero, or SecurMark Ultrasound
biopsy site marker, remove the spacer provided in the
packaging and install it onto the biopsy site marker until it
engages into place. (Figure 1)
5. Set-up the appropriate ATEC handpiece per standard operating
procedures to perform an ultrasound-guided biopsy utilizing
the ATEC Breast Biopsy and Excision System.
Release Date: 03/26/2025
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