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2. Safety > 2.16. Reporting of incidents
Patient safety requires that the user can view the screen of the Sonalleve console any time during
the therapy. For the same reason the system does not automatically blank or lock the screen
during therapy, even when the user does not use the Sonalleve console for a while.
The intended use of the system prohibits automatic logoff during therapy. At the default level of
user access, automatic logoff takes place on exit from the Sonalleve application.
To log off when operating the system as a power user (see 10.7.1. About accounts):
1.
Exit the Sonalleve application, if it is running.
2.
Simultaneously press the Ctrl, Alt and Delete keys.
3.
Select Sign out.
2.15.1. Malware detection
The Sonalleve console is equipped with antivirus software that is designed to detect viruses on
your system and to deny access to infected files before the files can damage your system.
Profound Medical makes available Sonalleve security updates that contain security-related updates
to the Windows operating system and to the anti-virus software. The security updates are validated
by Profound Medical and must be controlled for this product. The updates are distributed by the
Profound Medical service organization. Remote installation of security updates is not supported
because it could involve risk to patient safety.
If the antivirus software has detected malware infection, do not use automatic repair utilities
because the integrity of the repaired software cannot be guaranteed. Contact the Profound Medical
service organization to assess and repair the system. You should adhere to local malware policies,
which may include disconnecting from the network until the situation is resolved.
2.15.2. Remote Desktop
Service can access the system remotely by using Remote Desktop functionality. During Remote
Desktop session the current user is locked out but can gain access to the system again by
pressing any key.
WARNING
The local user is responsible for ensuring the safe and secure use of the system and for the
safety of the patient. A Remote Desktop session shall only be performed with the
appropriate safety, security and privacy measures taken according to hospital policies.
During a Remote Desktop session, the local user must stay at the system console and
monitor the activities performed by the remote user.
2.16. Reporting of incidents
Any accident and/or injury to a patient, operator, or maintenance personnel that has occurred while
using the equipment should be reported to Profound Medical. Please contact your local Profound
Medical representative.
Any serious incident that has occurred in relation to the device should be reported to Profound
Medical and the competent authority of the Member State in which the user is established.
2.17. Safety improvements
Safety improvements to the equipment must be installed only by Profound Medical personnel.
Instructions for Use
109745C2 / 02-2022
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