Caution: Federal law restricts this device to sale by or on the order of a physician, or any other prac-
titioner licensed by the law of the State in which the practitioner practices to use or order the use of
the device and are trained and experienced in the use of the ThinPrep
®
Integrated Imager.
The ThinPrep
®
Integrated Imager is a PC-based automated imaging and review system for use with
ThinPrep cervical cytology sample slides. The ThinPrep Integrated Imager is intended to help a
cytotechnologist or pathologist highlight areas of a slide for further manual review. The Product is
not a replacement for manual review. Determination of slide adequacy and patient diagnosis is at the
sole discretion of the cytotechnologists and pathologists trained by Hologic to evaluate ThinPrep-
prepared slides. If and only if it is finally determined by a court of competent jurisdiction that the
Product sold to Customer hereunder was defective in design or contained a manufacturing defect
and that such defect was solely responsible for an error in diagnosis that caused harm to a patient,
Hologic shall indemnify Customer for the compensatory damages paid by Customer to discharge
the personal injury judgment with respect to Product.
© Hologic, Inc., 2018. All rights reserved. No part of this publication may be reproduced,
transmitted, transcribed, stored in a retrieval system, or translated into any language or computer
language, in any form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual,
or otherwise, without the prior written permission of Hologic, 250 Campus Drive, Marlborough,
Massachusetts, 01752, United States of America.
Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes no
liability for any errors or omissions, nor for any damages resulting from the application or use of this
information.
This product may be covered by one or more U.S. patents identified at
http://hologic.com/patentinformation
Hologic, PreservCyt, and ThinPrep are registered trademarks of Hologic, Inc. in the United States
and other countries. All other trademarks are the property of their respective companies.
Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Document Number: AW-16644-001 Rev. 002
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