header for the data set. Because of this, the software's measurements should be used for reference only
until the accuracy of the DICOM header information can be verified or the image information has been
calibrated through the use of a measurement instrument in the image.
When interacting with the worklist, you should be aware that while you are viewing any images and reports,
any real-time updates on image information or availability will not automatically be seen in your current
viewing session. These updates can only be viewed if you perform a new search and re-access the updated
study.
Response times
Response time will vary depending on several factors, including:
network latency (response time may be slower if you are using a remote or shared wireless data
connection, for example),
bandwidth consumption (devices with higher resolution monitors cause the server to render
larger images, which consumes more bandwidth), and
the particularities of the displayed images (window/level and other settings affect how well the
images can compress, which also impacts response time)
Risk of potential errors
While the Synapse Mobility software has been tested extensively, it is impossible to completely test any
piece of software, and errors may remain. It is possible that an error could manifest as an incorrect
measurement or image. You must be aware of the potential for errors.
Certain views make use of interpolated data. This is data that is created by the software based on the
original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology
that is near or smaller than the scanning resolution may be present.
Training & user familiarization
It is strongly recommended that user training be conducted by each institution implementing Synapse
Mobility. This training should include:
1. Institutional on-call process for reviews to be performed using the technology.
2. Log-in protocols and security for access to the Synapse Mobility server.
3. Operation of the software and practice on various uses cases including use of the product under
various lighting conditions.
4. Review of labeling including indications for use, warnings, precautions, and directions of use.
5. Criteria for activation of fall-back procedures should access to imaging data not be available or
fail during attempts to access it.
6. How to access user and product support through the institution.
7. Review of criteria and procedures for reporting adverse events.
Synapse® Mobility User Guide for HTML5 Preface
Confidential and Proprietary
DOC-0046692-A
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