TREK Diagnostic Systems Ltd, Units 17 - 19, Birches Industrial Estate, East Grinstead, West Sussex RH19 1XZ,
United Kingdom
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL
NOT
BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN
CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT. Thermo Fisher Scientific and
its subsidiaries are not responsible for any performance issues or defect as a result of abuse, neglect, or failure to operate and
maintain equipment as outlined in any user documentation. This is extended, but not limited to (1) operation of the system by
personnel not trained by the manufacturer or approved distributor, (2) any attempts to modify, alter, service, or repair the
equipment by any person other than those approved by Thermo Fisher Scientific that have completed requirements to do so,
and (3) changes in form or function of consumables approved for use with this instrument.
Revision history: Pub. No. MAN0018223 (English)
Revision
C.0
15 June 2022
B.0
A.0
19 March 2019
TRADEMARKS: Steris and SPOR-KLENZ are trademarks of Steris Corporation. All other trademarks are the property of
Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2022 Thermo Fisher Scientific Inc. All rights reserved.
Sensititre AIM™ Instructions for Use
Date
Supersedes < AIM user manual EN CID11166>
Update of document to comply with EU 2017/746 (IVDR) Annex I, section 20.4.1.
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23 April 2019
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Initial release in Thermo Fisher Scientific document control system.
Supersedes <AIM-US-FDA-V1 4 CID9104> and <AIM-GB-V1.5-CID9104>.
Updated to the current document template, with associated updates to trademarks,
logos, licensing, and warranty.
The ATCC Licensed Derivative®
Emblem, the ATCC Licensed
Derivative® word mark, and the
ATCC catalogue marks are
trademarks of ATCC. Thermo
Fisher Scientific Inc. is licensed to
use these trademarks and to sell
Description
Updated wording Operators Manual to Instructions for Use
CID updated to CID11193
Information for safety updated
Conformity marks updated
Safety and Electromagnetic Compatibility (EMC) warnings updated
Safety standards added
EMC Standards and Regulations added
Environmental design Standards and Regulations added
Statement regarding 'Serious Incidents' added.
Medical Device Symbols updated.
Sentence for professional use added
'Materials Provided' and 'Materials Not Provided' sections added.
Technical specifications updated
Appendix A wording updated
Appendix B table numbering updated
Documentation and support section wording updated
Added trademark information about Steris Corporation.
Added description of Vizion system.
Changed "g" in gram from upper to lower case to be consistent.
Capitalized the word abbreviation "MERO".
Added the word "organisms" after negative in Table 4 figure title.
CID number : CID10505
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