Optopol SOCT Copernicus - Disposal; Protective Measures for It Systems; Cybersecurity Functions; System Overview

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SOCT User Manual Version 10.0 rev. A
Disposal
For disposal at the end of the product life cycle, please follow national regulations.
CAUTION: Do not use this instrument for purposes other than intended and
specified.
Protective Measures for IT Systems
Manufacturer recommends operating SOCT only on password-protected systems.
SOCT must only be operated on virus-protected computers/networks. The institution
operating the device is responsible for the safety of the network.
When using external storage media, the user is responsible for ensuring that the media is free
from viruses. The consequences of virus attacks cannot be foreseen.
Manufacturer will not accept any liability for damage due to a computer virus.
NOTE: User must periodically backup patient data. Manufacturer will not accept any
liability for lost data.
Manufacturer recommends the use of an established antivirus software and/or firewall such
as e.g. Norton, McAfee.
The SOCT is tested by the manufacturer with anti-virus protection provided with Windows 10
“Microsoft Security Essentials”.
Make sure that your operating system, your medical device software and your antivirus
software are always working properly and up-to-date.
Make sure that all changes, updates and patches including operating systems are validated
prior to installation.
For questions regarding cyber security contact Manufacturer.
Cybersecurity Functions
The purpose of this section is to summarize the cybersecurity controls for the SOCT with Windows
10 operating system.
Cybersecurity risk management is a shared responsibility among stakeholders including the
medical device manufacturer, the user, and the health care facility. Failure to maintain
cybersecurity can result in compromised device functionality, loss of data availability or integrity,
or expose other connected devices or networks to security threats.
System Overview
The SOCT device has the following interfaces that are critical for cybersecurity:
- ETHERNET port /Wireless connection for DICOM interface