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Insightec Exablate 2100V1 - 2.6. System Security and Malware Protection

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SAFETY
Manual Part Number
39
After each treatment, the transducer should undergo a cleaning and high-level disinfection (HLD)
procedure, as described in Appendix C of this manual.
Prior to every application of energy ensure that the water interface is full.
The Sonication Power-On light in the magnet room indicates that the transducer is applying ultrasound
energy. This light must be in clear view of the nurse and the console operator. Never move the patient or
place your hand near the transducer while the sonication power-on light is illuminated.
It is hereby stated that no patients or operators are exposed to any hazardous material.
No modification of this equipment by non-authorized personnel is allowed.
2.6. System Security and Malware Protection
The Exablate system is a standalone system that is not connected to external networks (including the
hospital network) and is connected to the MRI via a private MRI-equipment hub that is obscured from the
hospital backbone network.
The WS PC has two connections. One is direct communication with the MRI internal equipment network.
This local point-to-point connection has no direct access to external hospital network and is solely used by
the Exablate system and the MRI scanner. The second connection is between the Exablate WS and the
Exablate Control PC, which is also an internal, point-to-point connection.
For MRI security and malware protection, refer to the MR system operator's manual.
CAUTION:
Do not insert into the USB ports any unauthorized devices, including radiofrequency (RF)
transmitters, nor use the USB ports to charge other equipment.
[C-2]
The Exablate system also has additional mechanisms to ensure file and data integrity. These mechanism
include hard drive integrity protection as well as prevention of any unauthorized change or modification to
the system configuration files.
All Exablate software related updates and/or modifications are performed by only INSIGHTEC personnel, or
other qualified personnel approved in writing by INSIGHTEC.

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