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MOSAIQ User's Guide - UCSF Radiation Oncology

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Disclaimer<br />

Training<br />

Introduction<br />

Elekta/Impac Medical Systems assumes no liability for use of this document if any<br />

unauthorized changes to the content or format are made. The information in this guide has<br />

been reviewed and validated for accuracy. The instructions and descriptions are based on<br />

<strong>MOSAIQ</strong> 2.0. Elekta/Impac Medical Systems reserves the right to update the document to<br />

improve the content and/or design.<br />

This guide is provided without warranty of any kind, implied or expressed, including, but<br />

not limited to, the implied warranties of merchantability and fitness for a particular purpose.<br />

Elekta/Impac Medical Systems assumes no liability for damages incurred directly or indirectly<br />

from not following the instructions, warnings, and cautions in the guide properly when using<br />

the <strong>MOSAIQ</strong> software.<br />

<strong>MOSAIQ</strong> is installed by a qualified Elekta Impac Software installer/engineer. The<br />

installer/engineer configures some components of <strong>MOSAIQ</strong>; however, the staff system<br />

administrators at your facility also configure settings in <strong>MOSAIQ</strong> according to the <strong>MOSAIQ</strong><br />

system configuration guides. Users certify acceptance of validated product installation via<br />

Customer Acceptance Testing.<br />

<strong>MOSAIQ</strong> users must receive adequate training on safe and effective use of the software<br />

before attempting to work with it. Training requirements may vary from country to country.<br />

Users must make sure that training is received in accordance with local laws or regulations<br />

that have the force of law. Information on training is available from your local Elekta Impac<br />

Software sales representative.<br />

Patient/User Safety and Residual Risk<br />

ELEKTA/Impac consciously designs its products to minimize risk to patient and user safety.*<br />

ELEKTA/Impac incorporates extensive precautions to mitigate potential system hazards. Due<br />

to the nature of the product, a low level of residual risk may exist during use. All residual<br />

risks inherent to this product have been deemed to be as low as reasonably practicable.<br />

ELEKTA/Impac provides training and user documentation and expects users to operate the<br />

system with due diligence and strictly heed all messages and warnings. Because it is unable to<br />

protect against all misuses, faults and device failures, ELEKTA/Impac maintains that only<br />

personnel who have studied this material are qualified to use this product. This product shall<br />

be used in accordance with all applicable user, patient, and environmental safety guidelines<br />

by users with adequate training, experience, and qualification.<br />

* ELEKTA/Impac complies with ISO 14971, Application of Risk<br />

Management to Medical Devices.<br />

Copyright 2010, Elekta Impac Software 3<br />

LUGMSQ0002/4.0/23-Sep-2010

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