BTG Visual-ICE - Accessory Products Used to Conduct Cryoablation Procedures; Storage

Visual-ICE™ Cryoablation System
1-3
1.3.2 Accessory Products Used to Conduct Cryoablation Procedures
The following items used with the Visual-ICE System are sterile, single-use only devices. Do not re-
sterilize or reuse.
• Galil Medical Cryoablation Needles: The Visual-ICE System is used only with Galil Medical
cryoablation needles. The cryoablation needles are available in a range of congurations that
produce various iceball sizes and shapes, allowing the clinician to match the needles to the
desired ablation zone. The cryoablation needles are supplied sterile in procedure kits or in needle
kits.
• Cryoablation Needle Labels
• Galil Medical Multi-Point Thermal Sensor™ (MTS): The Multi-Point Thermal Sensors (MTS)
contain four sensor locations along the distal shaft of the needle to monitor temperature near the
target site and adjacent critical structures. The cryoablation needles and MTS are supplied sterile
in procedure kits or in needle kits.
• Galil Medical Urethral Warming Set: The single use, disposable Urethral Warming Set is the
conduit that circulates warm saline through the urethra during a prostate cryoablation procedure.
• CIVCO Percutaneous Instrument Template
The following items used with the Visual-ICE System are re-usable and should be cleaned and/or
sterilized in accordance with the Instructions for Use that accompanies each product.
• Galil Medical Prostate Procedure Template: The Prostate Procedure Template is used to
guide needle placement during a prostate cryoablation procedure.
• IV Pole and Bracket for use with a uid warmer and pump system
The following items are needed to conduct cryoablation procedures and are not available from Galil
Medical.
• Argon gas cylinder(s)
• Helium gas cylinder(s) if using helium for thawing
NOTE: The argon and helium gases must meet the purity requirements specied in Section 8.4.
• A uid warmer and pump system when using the Galil Medical Urethral Warming Set
Galil Medical recommends the use of a sterile drape (customer supplied) to cover the touch screen if
the system will be operated by members of the sterile team.
1.3.3 Storage
Store the Visual-ICE System in a cool, dry, secure location. Storage conditions should be within
-15°C to +50°C and 10% to 90% relative humidity.