Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
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Hotline: 0700-berlinheart (+49(0)700 23754643)<br />
This document relates to the following versions:<br />
• <strong>Ikus</strong> software: from V 3.40 RC0029<br />
• Laptop software: from V 3.40V<br />
• Laptop from CF27<br />
Approval and con<strong>for</strong>mity declaration<br />
Manufacturer<br />
<strong>Berlin</strong> <strong>Heart</strong> GmbH<br />
Wiesenweg 10<br />
12247 <strong>Berlin</strong><br />
Imprint<br />
© January 2008<br />
<strong>Berlin</strong> <strong>Heart</strong> GmbH<br />
Wiesenweg 10<br />
12247 <strong>Berlin</strong><br />
All rights reserved.<br />
This handbook may not, in full or in part, be reproduced, sent, transmitted in an electronic<br />
medium, stored in a data processing system or translated into another language without the<br />
written consent of <strong>Berlin</strong> <strong>Heart</strong> GmbH.<br />
This handbook is intended <strong>for</strong> in<strong>for</strong>mation purposes only. The contents of this handbook may<br />
be expanded, modified or updated at any time without notification.<br />
Previous versions of the instructions <strong>for</strong> <strong>use</strong> become invalid with the publication of this version.<br />
All translations of this handbook were per<strong>for</strong>med and checked to the best of our knowledge and<br />
belief. However, only the German and English editions of this handbook are valid as the legally<br />
binding versions.<br />
Licenses, trademarks and brand names<br />
EXCOR ® , INCOR ® and are brands / trademarks of <strong>Berlin</strong> <strong>Heart</strong> GmbH.<br />
They are protected in Germany and other countries.<br />
All other trade names mentioned in this handbook are subject to the rights of their respective<br />
owners. These rights are expressly recognized and respected wherever these names are <strong>use</strong>d in<br />
this publication.<br />
Text and design<br />
<strong>Berlin</strong> <strong>Heart</strong> GmbH<br />
The EXCOR ventricular assist device (UMDNS number: 10-847) fulfils the<br />
requirements of Guideline 93/42/EWG <strong>for</strong> Class 3 medical device. The<br />
entire EXCOR system including the <strong>Ikus</strong> and all consumable materials<br />
have carried the CE mark since 1996.<br />
1000002 Rev. 4.9.1 i
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