2. SAFETY
2.1. Exablate Safety Considerations
Exablate Prostate was designed and manufactured to ensure maximum safety of operation. Maintain the
system in strict compliance with the safety precautions, warnings, and operating instructions in this manual.
The Exablate Prostate should be installed, maintained, and serviced by only INSIGHTEC personnel, or other
qualified personnel approved in writing by INSIGHTEC.
The Exablate Prostate, in whole or in part, should not be modified in any way without the prior written
approval of INSIGHTEC.
The Exablate Prostate system must be used under the supervision of a physician who has successfully
completed the INSIGHTEC training program.
The owner should ascertain that only fully qualified, properly trained and certified personnel according to
INSIGHTEC training program, are authorized to operate this equipment.
Only trained and certified clinicians, specializing in Urology, Radiology and/or Radiation Oncology should
use the Exablate Prostate system for treatment of patients.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and
the country regulatory authority.
It is important to keep this manual near the system. It should be studied and reviewed periodically by all
authorized operators. However, INSIGHTEC makes no representation that the act of reading this operator’s
manual renders any user qualified to test, calibrate, or operate the system.
Unauthorized personnel should not be allowed access to the system.
If the system does not operate properly or fails to respond as expected to the controls as described in this
manual, tend to the safety of the patient first, and then attend to the system.
The Exablate 2100V1 is compliant with Directive 2011/65/EU of the European Parliament (Restrictions of
Hazardous Substances, RoHS).
As required by IEC60601-1 (3.1 edition) to define:
◼ System applied part list: FUS cradle.
◼ System accessory part list: Leg supports, endorectal silicon probe cover (single-use, non-sterile
introduced), water-based US gel (single-use, non-sterile introduced) and purified water bottles
(single-use, non-sterile introduced).
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