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7
.
7
Cybersecurity
Limitation of unauthorized access through
-
deactivation of
- boot option from external devices
- automatic Windows updates
-
password protection of
- whole device
- Windows access
- BIOS access
-
possible exclusion / no essential need for
- internet
- WIFI
- bluetooth
Limitation of data loss through
-
internal energy storage
-
backup option (USB) for training data
Further measures
-
software design acc. to IEC 62304 (software life-cycle processes)
-
re-confirmation of external control on the UserTerminal
-
warnings concerning handling of patient data in instructions for use
-
information / warnings for intergration by IT administrators in instructions for use
-
no patient database
7
.
8
Fire-
f
ighting
Apply all-pole disconnection from voltage power supply, preferrably through triggering respective FUSE circuit breaker.
Do not use liquid fire-fighting resources.
Use preferrably CO2 or powder fire extinguisher.
7
.
9
All-pole disconnection
The following options are available for all-pole disconnection from voltage power supply:
❚
Unplug device from power socket.
❚
Unplug cable from device (if possible).
❚
Switch off device protection switch.
❚
Trigger residual current circuit breaker / RCD of the building.
Maintain enough free space to ensure access to cables, power plugs and the circuit breaker (see “position of subject and operator”).
7
.1
0
Summary of safety and clinical performance
See following link:
https://www.hpcosmos.com/en/contact-support/media-downloads/certificates
❚
MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 25 of 97