Data security

Your System Administrator is responsible for backing up the image server. Backups MUST be verified regularly to avoid patient data loss.

Only allow authorized personnel to access the data. Changes to data may lead to incorrect diagnosis.

Implement measures to protect personal patient data from misuse.

If a critical error occurs during capture you should review the saved images and scans, and recapture scans and images if necessary.

Exit OptosAdvance before turning OFF the image server.

You can install critical Windows Updates and antivirus signatures on the Image Server PC and Viewing PCs by following the instructions displayed during the update.

IT networks used by medical devices

Connection of the device to an IT NETWORK/DATA COUPLING that includes other equipment could result in previously unidentified RISKS to PATIENTS, OPERATORS or third parties.

The RESPONSIBLE ORGANIZATION should identify, analyze, evaluate and control these RISKS.

Subsequent changes to the IT NETWORK/DATA COUPLING could introduce new RISKS and require additional analysis, and changes to the IT NETWORK/DATA COUPLING.

These include

• changes in the IT NETWORK/DATA COUPLING configuration

• connection of additional items to the IT NETWORK/DATA COUPLING

• disconnecting items from the IT NETWORK/DATA COUPLING

• update of equipment connected to the IT NETWORK/DATA COUPLING

• upgrade of equipment connected to the IT NETWORK/DATA COUPLING.

The image server should be kept in a secure location. You are resposible for maintaining the security of information stored on the image server.

You are responsible for the security of user accounts and the maintenance of password security.

The data upload may result in illegal or inappropriate images being ingested into the system that can potentially introduce cybersecurity risks. The healthcare provider is responsible to implement the cybersecurity best practices.

This portal can only be activated under the consensus of the healthcare provider, and distributed under this consensus.

A user’s access to the OptosAdvance software is dependent upon the connectivity of their computer or mobile device to the OptosAdvance server. An OptosAdvance site should maintain the network integrity since the network is a critical part of the distributed image viewing system.