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Insightec Exablate 2100V1 - 2.2. Symbols Used in the System

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SAFETY
Manual Part Number
28
2.1.1. Use of Exablate System within the MRI Environment
The Exablate Prostate Patient Table is MR Safe
2.1.2. Use of MR Equipment
Personnel operating the MR equipment must have a thorough understanding of the proper operation of
the system.
Do not operate the MR equipment before reading the appropriate user manuals and gaining a clear
understanding of the operation of the system. If any part of the MR system's manual is not clear, contact
the MR equipment's technical and/or clinical service personnel for clarification.
For the safety of the patients, operating personnel and technical personnel, all operating instructions and
particularly the safety instructions therein must be strictly adhered to.
2.1.3. System Service
The Exablate system should be installed, maintained, and serviced by INSIGHTEC personnel, or other
qualified personnel certified by INSIGHTEC.
Periodic maintenance should be performed regularly according to INSIGHTEC service standards by
INSIGHTEC or by INSIGHTEC certified personnel.
An Exablate Prostate system should be serviced every six months.
WARNING:
If a system is not appropriately serviced and maintained, it should not be clinically
operated.
[W-2]
2.2. Symbols Used in the System
Symbol
Symbol Title
Description
Standard Reference
CE mark
Designates that the product labeled is
authorized for sale in EU.
EU 2017/745

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