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Using the sterilizer
5.12 Cybersecurity
This sterilizer has been designed and manufactured by NSK Dental Italy with the aim of removing, as far as
possible, the impairment of performance or the risks associated with possible negative interactions between the
device and the IT environment in which it operates, even if the medical device does not patient data is managed or
saved, but only cycle reports.
To check the current firmware version use the menu.
To prevent unauthorized use NSK Dental Italy has applied an intrinsically safe design which includes:
• End-to-end (TLS) encrypted data communications are used to keep communications with NSK Cloud
confidential.
• Digital signatures are used to preserve integrity. Highly sensitive data, such as firmware updates, are accepted
by authenticated end-points.
• Data flows in only one direction from the Ethernet port, the security context must be mutually authenticated,
and cryptographic mechanisms, including encryption and signature verification, must be bi-directional.
• Corrections or firmware updates from NSK Dental Italy will be available promptly if needed and should be
applied as soon as available. Systematic procedures will be in place for authorized users to download and
install updates from NSK Dental Italy once a patch or new firmware is available.
• Full support will be available for users, in case of requests regarding device cybersecurity please write to
servicesterilization@nsk-italy.it.
Then, to mitigate the risk of cybersecurity threats:
• the IT network where the device is installed and connected must be appropriate for this medical device (for
example, the use of configurations may include end point protections such as anti-malware, firewall/firewall
rules, whitelisting, security event parameters, logging parameters, physical security detection).
• Only the Ethernet port can be used to communicate with NSK Cloud.
• allow the use of the device only to suitable and adequately authorized personnel
• users must be careful not to spread their pins to enter the technical menu.
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