Galil Visual-ICE MRI, Руководство пользователя

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Visual-ICE
™
MRI Cryoablation System
1-5
1.6 Warnings
•
Personnel present when making all connections prior to a cryosurgical procedure must be
completely familiar with all routine precautions taken in an MRI environment.
• The Visual-ICE MRI Cryoablation System Console is MR Unsafe. Never place the Console in the
magnet room.
• The Visual-ICE MRI Cryoablation Needles may heat up when the scanner RF field is active.
Hazards associated with heating can be minimized by using scan sequences with low SAR and
limiting the duration of the scan. It is recommended that the scanner be operated in Normal
Operating Mode with a whole body averaged specific absorption rate (SAR) of ≤1.5 watts per
kilogram (W/kg). It is also recommended that the scan duration be limited to about one minute per
scan if the needle is not operating in freezing mode during the scan.
•
Do not use this device for any purpose other than the stated intended use and indications for use.
•
A thorough understanding of the technical principles, intended use, indications for use and
risk associated with cryoablation procedures is necessary before using this product. Use of
this device is restricted to use by or under the supervision of physicians trained in cryoablation
procedures with a Galil Medical cryoablation system.
• Do not start a cryoablation procedure before verifying that the Visual-ICE MRI Cryoablation
System and all ancillary equipment are fully operational.
• Verify that the Ethernet cable is disconnected prior to starting a cryoablation procedure. Do not
connect the Ethernet cable during a cryoablation procedure.
•
Do not use the Visual-ICE MRI Cryoablation System if the system is visibly damaged, exposing
any internal components or sharp edges.
•
Have sufficient gas (argon / helium) available to conduct the planned cryoablation procedure: the
number and type of needles, gas cylinder size, pressure and rate of gas flow affect the required
gas volume.
• Secure the safety cable at the end of the gas supply line to the console bracket on the Visual-ICE
MRI Console before connecting the gas supply line to the gas inlet. The safety cables provide
backup protection if the gas supply lines become inadvertently disconnected from the system.
• Confirm that the gas connections to the Console and the Mobile Connection Panel are securely
connected.
•
Lock the wheels on the Visual-ICE MRI Mobile Connection Panel prior to using the system to
avoid inadvertent movement during a procedure.
•
Each needle must be locked into a needle channel before initiating a cryoablation procedure to
avoid the risk of forceful ejection of the needles from the Mobile Connection Panel while under
gas pressure.
• Do not unlock the locking bar for any needle channel if the GAS Pressure Indicator LED is solid
white. Unlocking the locking bars when the channels are under pressure could result in forceful
ejection of the needle connectors.
• Before the patient is anesthetized, the Needle Integrity and Functionality Tests on the MRI
cryoablation needles must be completed successfully to verify proper needle operation.
•
Do not pull on the power cord. Grasp the plug, not the power cord, to disconnect the device from
the wall socket.
•
Do not modify the Visual-ICE MRI Cryoablation System in any way. Only authorized Galil
Medical personnel or Galil Medical-trained authorized personnel are to service a Visual-ICE MRI
Cryoablation System.