Insightec Exablate 2100V1 - 2.3. Safety Instructions

SAFETY
Manual Part Number
32
Symbol
Symbol Title
Description
Standard Reference
Protective earth
(ground)
Identifying any terminal, intended for
connection to an external conductor for
protection against electric shock in case of
a fault, or the terminal of a protective earth
(ground) electrode.
IEC 60601-1 3.1Ed
Table D.1 (6)
Input; entrance
Indicating an entrance (e.g. hydraulic
pump).
ISO 7000-0794
Output; exit
Indicating an exit (e.g. hydraulic pump).
ISO 7000-0795
Method of
sterilization
Method of sterilization using ethylene
oxide.
ISO 15223-1: 2016,
clause 5.2.3
MR Safe
Indicates that the device is safe- it poses no
risks in any MR environment.
ASTM F 2503-13
2.3. Safety Instructions
WARNING:
Before using the Exablate Prostate system:
◼ Read and understand each of the following safety warnings.
◼ Refer to the safety information supplied with the MRI System.
◼ The Exablate Prostate is type BF applied part.
◼ It is properly grounded by design and by the installation process.
◼ It is important for the safety of the patient and operator to maintain proper system
grounding. Connect the system as instructed, and do not disconnect any of the
system installation connections.
◼ The use of accessories, transducers and cables other than those specified or
provided by Insightec with this equipment may result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
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