USER MANUAL
Rev. A 2 May 2020
Copyright © 2020 by Alken, Inc. dba Polhemus
Colchester, Vermont, U.S.A.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in
any form or by any means, mechanical, photocopying, recording or otherwise, without the prior written
permission of Polhemus. No patent liability is assumed with respect to the use of the information contained
herein. While every precaution has been taken in the preparation of this manual, Polhemus assumes no
responsibility for errors or omissions. Neither is any liability assumed for damages resulting from use of the
information contained herein.
Windows® is a registered trademark of Microsoft Corporation.
Linux® is the registered trademark of Linus Torvalds in the U.S. and other countries.
Medical Device Use
The VIPER™ products are certified to meet the EN60601 conformance standards as noted in the following
sections. If VIPER™ products are used in a medical setting it is intended that they are used as medical device
components. Medical device components are products integrated into other medical devices or medical device
systems.
The VIPER™ system does not have a specific indication for use and there are no stand-alone regulatory clearances
or approvals for the VIPER™ itself.
As defined by FDA (21 CFR 820.3(c)), a component is any raw material, substance, piece, part, software, firmware,
labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device.
The end user/OEM/VAR/Distributor must determine how the VIPER™ products will be used and comply with all
FDA/CE regulations pertaining to the development and sale of finished medical devices and all other regulatory
requirements.
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