Copyright
© 2003-2023 Intelerad Medical Systems Incorporated. All Rights Reserved.
No portion of the contents of this publication may be reproduced or transmitted in any form or by any means without the express written permission of Intelerad Medical Systems Incorporated.
Except as expressly provided otherwise in writing, the information provided in this document is provided AS IS, without any condition or warranty, whether written, oral, express, implied, legal, or statutory. No condition or warranty of merchantability or fitness for a particular purpose applies to anything provided by Intelerad. Without limiting the foregoing, Intelerad nor any of its suppliers warrants this documentation is or will be accurate, error free or meets or will meet user requirements.
TRADEMARKS
Intelerad, Intelerad Medical Systems, and the Intelerad logo, IntelePACS, InteleBrowser, IntelePACS Browser, InteleViewer, Reporting Worklist Module, InteleOne, InteleOne XE, InteleFlex, Assignment Engine, InteleWeb, Acquisition Traffic Controller, Multi-Method Reporting, Intelerad Pulse, IntelePACS 3D, IntelePACS Image Fusion, InteleSuite, InteleRIS, Flow, Nuage, Disaster Recovery Services, Cloud Imaging Platform, Intelerad Peer Review, Intelerad Critical Results, Critical Results Module, ATC Portal, Panorama, InteleConnect, InteleConnect EV, Odyssey, Clario, Clario SmartWorklist, Clario Reporting, LUMEDX, HealthView Analytics, Digisonics, Heart Imaging Technologies, HeartIT, WebPAX, PRECESSION, Insignia Medical Systems, and Ambra are either registered trademarks or trademarks of Intelerad Medical Systems Incorporated or its affiliates.
THIRD-PARTY TRADEMARKS
Adobe, Acrobat, and Reader are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. Firefox is a registered trademark of Mozilla Foundation in the United States and other countries. Google Chrome browser is a registered trademark of Google Inc. in the United States and other countries. Internet Explorer is a registered trademark of Microsoft Corporation in the United States and other countries. Intel, Pentium, Pentium II Xeon, and Pentium III Xeon are trademarks or registered trademarks of Intel Corporation or its subsidiaries in the United States and other countries. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. NVIDIA is a trademark or registered trademark of NVIDIA Corporation in the United States and/or other countries. Oracle and Java are registered trademarks of Oracle Corporation and or its affiliates. PowerScribe 360 is a trademark or registered trademark of Nuance Communications Inc. or its affiliates in the United States and/or other countries. Sun, Sun Microsystems, and Java are trademarks or registered trademarks of Sun Microsystems, Inc. in the United States and other countries. Safari, Mac, and OS X are trademarks of Apple Inc., registered in the United States and other countries.
All other brand names, product names, or trademarks belong to their respective holders.
PERFORMANCE CHARACTERISTICS
The main benefits of IntelePACS are the improved image accessibility and associated time savings. There is also some indication that IntelePACS can help data integrity and help reduce operating costs in radiology. There is no significant indication that it affects or improves diagnosis accuracy and image quality. There have been some reports of adverse events associated with IntelePACS and some recalls linked to possible patient safety issues, but no strong case of adverse effects of using IntelePACS technology. IntelePACS technology is a low-risk medical device that has been used successfully and undergone continual refinements.
INDICATIONS FOR USE
IntelePACS is a software application that receives digital images and data from various sources (such as CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations
Mammographic images may only be interpreted using a display that is cleared, and that meets technical specifications reviewed and accepted, by your regulatory authorities.
IntelePACS on mobile devices (applicable for IntelePACS 5.1.1 or later only):
For Canada, United States, Europe, Australia, New Zealand, and South Africa only: When used with a mobile device, IntelePACS is suitable for diagnostic image review only on tested devices as specified in your Intelerad product's documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.
For all other countries: IntelePACS is not intended for diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.
CONTRAINDICATIONS—None.
Caution: Federal law restricts this device to sale by or on the order of a physician.
This system does not replace the education, skill, and judgment of properly trained medical practitioners. Only properly trained and qualified individuals shall have access to and use IntelePACS and must know of its functionality, capabilities and limitations. Typical users of this system are trained health professionals, physicians, nurses, and technologists.
Downloaded Images, Workstations and Isolated Installs: You and your users must maintain IntelePACS with the most current versions, including available updates and upgrades. Delaying or refusing updates or upgrades following a recall may result in a non-compliant IntelePACS
SAFETY ISSUES: IntelePACS is a medical device, and as such, must meet medical device safety and effectiveness requirements imposed by national regulations. Any unmonitored or unconnected use of IntelePACS, or use of IntelePACS without a valid right may put the health and safety of patients at risk as you will not be advised of the availability of any software patch, bug fix, update or upgrade nor will be informed of Field Safety Notices, Medical Device Recalls or Advisory Notices related to IntelePACS. Client and authorized users must consult national regulatory site(s) to be informed of Field Safety Notices, Medical Device Recalls or Advisory Notices related to IntelePACS. Intelerad does not have access to authorized users systems to implement corrections to prevent (or correct) occurrences of patient safety issues. You are responsible to flow down recall and patient safety information to your users. The user of the medical device must report any serious incident that has occurred in relation to the medical device to the manufacturer (Intelerad) and the competent authority having jurisdiction in their locale.
Referring Physicians Use: Images for authorized referring physicians may not be of diagnosis quality and should not be used for diagnostic purposes.
InteleConnect: Images in InteleConnect are intended for review only and are not appropriate for diagnostic purposes. Please use InteleViewer for diagnostic viewing.
CD Burning and Nuage Patient Portal: Intelerad Clients remain responsible for collecting patient consents and accesses. Images on CD and on Nuage Patient Portal are intended for review only and are not appropriate for diagnostic purposes. Please use InteleViewer for diagnostic viewing.
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Intelerad Medical Systems Incorporated
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IntelePACS UDI is: B228INTELEPACS0 |
AUSTRALIAN SPONSOR
Emergo Australia
201 Sussex Street, Darling Park, Tower 2, Level 20
Sydney, NSW 2000, Australia
tel: +61.0.2.9006.1662
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Title: |
InteleViewer Online Help |
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Software version: |
5.6.1 (Multiple Patient Multiple Use) |
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Date: |
2023-03-01 |
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Part number: |
IVEN5.6.1H-O Issue 007 |