Hologic ThinPrep, Operator'S Manual

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Caution: Federal law restricts this device to sale by or on the order of a physician, or any other
practitioner 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
®
Imager Duo Imaging
Station.
The ThinPrep
®
Imager Duo Imaging System is a PC-based and automated review system for use
with ThinPrep cervical cytology sample slides. The ThinPrep Imager Duo Imaging System 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., 2021. 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://www.hologic.com/en/about-us/patent-information/
Hologic, ThinPrep and PreservCyt are registered trademarks in the United States and other
countries.
H
net
is a trademark of Hologic.
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-24526-001 Rev. 001