Safety & Intended Use

General Information

This software program has been developed with the latest technology and is safe to use. To run CoreArchive safely and without errors, please follow the operating instructions set forth in this manual.

Manufacturers References

All trademarks, registered trademarks, product names, and company names and/or logos are the property of their respective owners.

Demonstration Data

All references to patient names and patient data in sample screen shots or in sample reports are for demonstration purposes only and not intended to refer to any actual person.

Certification

Core Sound Imaging, Inc. is certified by NSAI to be compliant with ISO 13485:2003.

Intended Use

CoreArchive is part of the Studycast® subsystem, which intended to be used by trained medical professionals (e.g. medical technicians and physicians) for the transmission, storage and presentation of medical images and associated medical image data, and the transmission, storage, summarization and presentation of medical diagnostic test results.

Rx Only

Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

General Guidance

Do not use CoreArchive outside the intended use.

CoreArchive is intended to be used for the purpose of transmission, storage and viewing of medical image data. The electronic documentation is the basis for medical interpretation of examinations. The diagnosis or decision for further examination has to be done by a trained, qualified medical professional following good clinical practices.

Improper use of the CoreArchive software can result in a false diagnosis. To avoid false diagnoses, consider the basic following safety precautions:

•Only medical professionals trained by Core Sound Imaging, Inc. should utilize the software. Training is part of the installation process and training can be requested from Core Sound Imaging, Inc., if needed.

•Do not attempt to use CoreArchive unless the manual has been consulted and is understood. Request training from Core Sound Imaging, Inc., if needed.

•Review the procedures and safety precautions periodically.

•Do not modify the software. Manipulations can cause data loss or a false diagnosis.