Audit Trail; Network Time Synchronization - Profound Sonalleve MR-HIFU Instructions For Use Manual

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10. Appendices > 10.6. Security and privacy features
The system does not provide functionality to synchronize with customer central user account
administration systems (LDAP, etc.).
The system supports only single user sessions. It does not provide application functionality to
register multiple simultaneous users or to switch between users other than via log-off / log-on.
The system does not support single sign-on for situations where the system works together with
other (optional) systems or is part of another system, e.g. extra workstations.
NOTICE
It is not possible to prevent the transfer of data to removable media.

10.6.2. Audit trail

Required to log user activities which are information-security critical:
Applies to logging-on, reading and/or modifying clinical information.
Uses the local Security Event Log which is accessible only to service and system
administrators.
Use of an external standard 'Syslog' server is not supported.
Application specific access information is stored in RFC-3881 format; Logon/Logoff information is
stored using Windows' event format.
Viewing the local audit log
To view the local audit log:
1.
Log on to the Sonalleve console as an administrator.
2.
Open the Windows Start menu.
3.
Select the Windows Administrative Tools folder.
4.
Under Administrative Tools, click Event Viewer.
Log-on, log-off and other security critical events are found in Windows Logs → Security.

10.6.3. Network time synchronization

The Sonalleve MR-HIFU system synchronizes its time to the MR scanner. It is possible to configure
the MR scanner to synchronize system time to an external time standard:
The MR scanner uses a standard Network Time Protocol (NTP) to synchronize system time.
A coupling between the scanner and an external time standard can be configured by the
Profound Medical service representative during the installation of the MR scanner.
The system time on the MR-HIFU system is synchronized to the system time on the MR scanner
during the QA Test (see 7.2.2. Performing the QA Test).
Instructions for Use
109745C2 / 02-2022
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