Contraindications; Device Description - Hologic Atec Bedienungsanleitung

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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
ultrasound introducer. It is not a reference to surgical techniques.
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.
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