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Interpolated data may give the appearance of healthy tissue in situations where pathology that is smaller than the scanning resolution may be present. This is data that is created by efilm based on the original data set. Users should be aware that certain views make use of interpolated data. It is important to protect this data from access by unauthorized persons.
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efilm saves images together with patient information, both when saving to the local database and when exporting from efilm. Users must be aware of the potential for errors. It is possible that an error could manifest as an incorrect measurement or image. While efilm Lite has been tested extensively, it is impossible to completely test any piece of software, and errors may remain in the software. For example, measurement values in efilm Lite are dependent on the calibration information provided by the modality in the DICOM header. The quality of the data is dependent on the correctness of the input data, the user s interaction with the data, the quality, characteristics, and settings of the display device or printer, and the necessity to interpolate the data for display purposes. The user should be aware of the limitations in the accuracy and correctness of the output data displayed on the screen, printed, or exported from efilm.
#VIEWER EFILM LITE SOFTWARE#
Our authorized representative in the European Community is: Anton van Kimmenade Merge emed Spegelt CD Nuenen NetherlandsĤ Considerations prior to use The software is not intended to replace the skill and judgement of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software s functions, capabilities and limitations. efilm satisfies the requirements for bearing the CE mark on its labelling. The K number for this product is K Europe According to the guidelines stated in Directive 93/42/EEC of the European Community, efilm is a Class I Medical Device. United States of America A 510(k) premarket notification for efilm with Modules was submitted to the United States Food and Drug Administration on March 19, On April 12, 2002, efilm received USFDA clearance as a Class II Medical Device.
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This product possesses a Class 2 Medical Device Licence issued May 30, 2001, by the Therapeutic Products Programme of Health Canada. Canada efilm is licensed for sale and use in Canada. Any additional software products named in this document are claimed as trademarks or registered trademarks of their respective companies.Ä£ Regulatory notes Merge emed provides you with the following information regarding the regulatory status of efilm in Lite form. Trademarks Merge emed, efilm, Fusion efilm, efilm Lite, efilm Scan, and efilm Video are all registered trademarks of Merge Technologies Inc. The authors of Merge emed shall have neither liability nor responsibility to any person or entity with respect to any loss or damages in connection with or arising from the information contained in this guide. Every effort has been made to make the information in this guide as accurate as possible. This guide has been produced to assist in providing instruction for the Merge emed product suite.
#VIEWER EFILM LITE MANUAL#
This manual shall not wholly or in part, in any form or by any means, electronic, mechanical, including photocopying, be reproduced or transmitted without the authorized, written consent of Merge emed. Phone: (414) Fax: (414) All Rights Reserved. Washington Street, Suite 2250, Milwaukee, WI, USA. 2 efilm Lite 2.1 User Guide Version 1 Part number OctoCopyright notice Copyright 2005 Merge Technologies Inc W.