BD PrepMate Automated Accessory - Page 2

BD PrepMate™ Instrument User’s Manual
2
Change History
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Dickinson and Company or its affiliates. © 2022 BD. 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 Becton, Dickinson
and Company, 7 Loveton Circle, Sparks, Maryland 21152, USA.
Unauthorized changes or modifications to the BD PrepMate™ Automated Accessory may void the user’s
warranty.
*Product is not CE marked to Regulation (EU) 2017/746 and not represented by the stated EU Authorized
Representative.
Revision
Date Change Summary
03 2018-11 Added use with BD Totalys™ SlidePrep and
BD CytoRich™ Clear Vial.
04 2020-04 Updated operating conditions and added number of
fuses to Operational Specifications section. Added
serious incident information to Warranty section.
Added intended user information under Safety and
Precautions section Converted printed instructions
for use to electronic format and added access
information to obtain the document from
bd.com/e-labeling.
05 2022-01
Updated for IVDR 2017/746.
Updated ISO Symbols.
Updated Manufacturer address.
Updated EC REP symbol and address.
Added CH REP symbol and address.
Added Technical Service and Support statement.
Added Safe Disposal Statement.
Updated BD Trademark and Copyright statement.
Updated Intended Use section.
Updated Requirement section with Intended User
statement.
Updated About this manual and Operating
sequence details sections.
Updated Serious Incident statement.
Added use of a footnote indicating which products
are not CE marked.
*Product is not CE marked to Regulation (EU)
2017/746 and not represented by the stated EU
Authorized Representative