Hologic Faxitron CT, Руководство пользователя

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FAXITRON CT USER MANUAL | HOLOGIC | REVISION 002
TABLE OF
CONTENTS
0-2
All rights reserved. No parts of this work may be reproduced in any form or by any means - graphic, electronic, or
mechanical, including photocopying, recording, taping, or information storage and retrieval systems - without the written
permission of the publisher.
Products that are referred to in this document may be either trademarks and/or registered trademarks of the respective
owners. The publisher and the author make no claim to these trademarks.
Read all this information carefully before operating the system. Follow all warnings and precautions as stated in this manual.
Keep this manual available during procedures. Always follow all the instructions in this manual. Faxitron Bioptics, LLC does
not accept responsibility for injury or damage from incorrect system operation. Faxitron Bioptics, LLC can arrange for training
at your site.
Unreleased Engineering Drafts
Draft 1.0 - Issued: 17 June 2017
Draft 1.1 – Issued: 06 July 2017
Draft 1.2 – Issued: 03 Aug 2017
Draft 1.3 – Issued: 08 Oct 2017
Draft 1.4 – Issued: 29 Mar 2018
Draft 2.0 - Issued: 30 Jan 2019
Released Versions
Revision 001 - Issued September 2019
Revision 002 – Issued March 2020
This manual was created by Faxitron Bioptics LLC. It is intended to guide the user on how to setup, install and use the
Faxitron CT hardware and the Software System, both developed by Faxitron Bioptics LLC.
Faxitron CT was previously known as VisionCT, and associated software was referenced as Vision softwarre. The software
is now referred to as the Faxitron CT software.
The user must first setup the hardware, then initiate the Faxitron CT Software. Please review the required setup procedures
in Part 2 of this manual before continuing.
Intended Use
The Faxitron CT is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of
harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been
excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be
completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit
the number of patient recalls.
 Prescription use (Part 21 CFR 801 Subpart D)
Caution: Federal law restricts this device to sale by or on the order of a physician
The system can operate as a stand alone device. If connected to a network it is critical that measures are implemented to
reduce the risk to patients by decreasing the likelihood that device functionality is intentionally or unintentionally
compromised by inadequate cybersecurity.
© 2019 Faxitron Bioptics LLC, a Hologic ® Inc. Company
Revision Record
Foreword