The Exablate system requires special precautions regarding electromagnetic compatibility
(EMC) and must be installed and put into service according to the EMC information
provided below:
◼ The Exablate system should not be used adjacent to or stacked with other
equipment and, if adjacent or stacked use is necessary, the system should be
observed to verify normal operation in the configuration in which it will be used.
◼ Be aware that portable and mobile RF communication equipment can affect the
Exablate system.
◼ The Exablate system should not be used adjacent to Portable RF readers. If use of
adjacent RFID readers is necessary, Insightec service must be informed to verify
normal operation in the configuration in which it will be used.
◼ Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Exablate System, including cables specified by Insightec. Otherwise,
degradation of the performance of this equipment could result.
◼ The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals. If it is used in a residential environment, this
equipment might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
◼ In case of system power loss due to AC inputs mains Voltage interruption, the
system will shut down. Wait for a stable return of the AC power and restart the
system to repeat the planning stage and resume the treatment. If the return of
power is delayed, and you decide to abort the treatment, proceed to patient
release procedure, as described in the operator’s manual.
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