BTG Visual-ICE, Руководство пользователя

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Visual-ICE™ Cryoablation System
1-5
1.6 Warnings
•
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 use a Visual-ICE Cryoablation System near magnetic resonance imaging (MRI)
equipment.
•
Do not start a cryoablation procedure before verifying that the Visual-ICE 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 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
System 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.
•
Lock the wheels on the Visual-ICE System prior to using the system to avoid inadvertent
movement of the system 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 system while under gas pressure.
• Before the patient is anesthetized, the Needle Integrity and Functionality Tests on the cryoablation
needles must be completed successfully to verify proper needle operation.
•
Do not touch the chassis of the Visual-ICE Cryoablation System while touching the patient to
avoid the risk of shocking the patient if an inadvertent electrical fault exists.
•
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 Cryoablation System in any way. Only authorized Galil Medical
personnel or Galil Medical-trained authorized personnel are to service a Visual-ICE System.
• Do not touch the screen if the touch-screen monitor goes blank for more than five (5) seconds
during a procedure. Immediately turn off power to the system and end the procedure to avoid
inadvertent activation of needles.
•
High-pressure gas is dangerous if handled improperly. Local laws and safety rules regarding
pressurized gas systems, reservoirs and components should always be observed.
•
The Visual-ICE Cryoablation System should not be operated in the presence of flammable fumes,
e.g., flammable anesthetics or volatile substances.
• The Visual-ICE Cryoablation System should be inspected and serviced periodically according
to the system specifications. Service must be performed by authorized service engineers.
Reference Section 6 for system care and maintenance information.