BTG Visual-ICE, Руководство пользователя

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Visual-ICE™ Cryoablation System
1-7
•
Do not use a USB extension cable to connect the USB flash drive to the USB port. Connect the
Galil Medical USB flash drive directly to the USB port provided on the Visual-ICE System. Use of
a USB extension cable may result in electromagnetic emissions exceeding regulatory limits .
•
Do not perform a cryoablation procedure with the Ethernet cable plugged into the Visual-ICE
System to avoid the potential risk of corrupting the system software. Only use the Ethernet cable
when downloading software updates or when uploading reports to the Galil server.
• Any person who connects external equipment to the Ethernet or USB ports has formed a Medical
Electrical System and is therefore responsible for the system to comply with the requirements. If
in doubt, contact a qualified medical technician or your local representative or Galil Medical.
1.7.2 Handling
•
Maneuver the Visual-ICE System by pulling on the system using the rear handle.
• Handle the Visual-ICE Cryoablation System with care. Rough handling may damage the system
and cause it to become inoperable.
• Do not bend or kink the gas supply lines. Sharp bends or kinks may compromise the integrity of
the gas supply lines.
•
Do not tilt the Visual-ICE Cryoablation System.
•
Lift the Visual-ICE System to clear any threshold that is higher than 2 cm. Two people, one on
each side, should use the handles to lift the system.
• Do not roll the Visual-ICE System over the gas supply lines; such activity may damage the lines.
• The Visual-ICE Cryoablation System is non-sterile. When attaching cryoablation needles to the
system, do not contaminate the sterile field or the sterile cryoablation needle. Avoid contact with
the distal portion of the cryoablation needle.
•
Position the Visual-ICE System in a manner to avoid draping needle tubing across the patient.
Needle tubing may become extremely cold when conducting freeze cycles during a cryoablation
procedure. It is important that a patient’s skin is protected from direct contact with needle tubing
to avoid the potential for thermal injury to the patient. Ensure an appropriate insulating barrier is
placed as needed (such as towels) or other method is employed to prevent needle tubing from
touching a patient’s skin.
•
Use care to avoid electrostatic discharge (ESD) events when removing the cover from the Visual-
ICE System. Galil Medical recommends that the operator touch one or more metal parts on the
rear of the system prior to touching anything on the Needle Connection Panel.
• Do not store liquids in the storage compartment. The storage compartment is not water tight.
1.7.3 During Use
•
Use image guidance to monitor needle insertion, iceball formation, needle positioning, and
removal.
•
Use Freeze and Thaw operations only when the needle is placed in the target tissue.
• Failure to operate the Visual-ICE System within the working pressure limits indicated on the user
interface (Table 4-2) may affect the cryoablation procedure.
• Needle handles frost during freezing. Avoid prolonged contact with frosted portions of a needle
handle to avoid unintended thermal tissue damage to the patient or clinician.