
CryoConsole Cardiac CryoAblation System
The CryoConsole is the device that powers the Arctic Front Advance™ Cardiac CryoAblation Catheter and the Freezor® MAX Cardiac CryoAblation Catheter. The console houses the electrical and mechanical components and software needed to perform cryoablation procedures. It controls the delivery, recovery, and disposal of cryoablation refrigerant safely and efficiently.
Overview
Advanced Technology for Efficient Operation
The CryoConsole encompasses the electrical and mechanical components and proprietary software for controlling a cryotherapy procedure with the Arctic Front Advance and Freezor MAX catheters. It stores and controls the delivery of the liquid refrigerant (N2O) through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheters and the CryoConsole to promote safety.
Flexible and Ergonomic
The CryoConsole features ergonomic design, a height-adjustable monitor, and touch-screen control for a straightforward procedure.
Intuitive Operation
Patient data and therapy variables are managed by a simple touch-screen interface. The screen also displays numerical and graphical data to help physicians and staff assess the status of the system, catheter-tissue contact, ablation time, and catheter temperatures. The CryoConsole can transmit information about the procedure to other EP recording systems for display purposes.
How the CryoConsole Works
The CryoConsole safely manages the delivery, recovery, and disposal of N2O during cryoablation procedures. Its components and software operate the Arctic Front Advance and Freezor MAX catheters, and provide continuous monitoring ensuring system safety.
Perform and Monitor, Cryoablation Procedures
During a cardiac ablation procedure, pressurized liquid nitrous oxide (N2O) is delivered from a tank in the CryoConsole. The liquid refrigerant travels in an ultra-fine tube through the coaxial umbilical and the shaft of the cryoablation catheter to the tip of the catheter.
The liquid refrigerant vaporizes as it is sprayed into the tip. As it vaporizes, it absorbs heat from the surrounding tissue, thereby cooling and freezing the target tissue. The warmed refrigerant is vacuumed back to the CryoConsole through a large lumen within the shaft of the catheter and coaxial umbilical. The CryoConsole discharges the vapor into the hospital scavenging system.
Specifications
The CryoConsole is compatible with the Arctic Front Advance™ and Freezor MAX catheters.
Size
Height (max): 157 cm
Height (min): 126 cm
Depth: 59 cm
Width: 55 cm
Weight: 131 kg (without nitrous oxide tank)
Other Specifications
Power input parameters: 110/120/230V
Operational parameters: 15-30°C; maximum of 75% humidity
Refrigerant: Liquified nitrous oxide (N2O); 99.5% purity with humidity level < 50 ppm
Accessories
In addition to the CryoConsole and the cryoablation catheters, the Cardiac CryoAblation System consists of sterile, single-use cables, as well as nonsterile accessories. The coaxial umbilical provides the refrigerant transport to the catheter and vapor recovery to the CryoConsole. The electrical umbilical provides the electrical connection between the catheter and the CryoConsole. The Auto Connection Box provides an electrical interface to the catheter. The ECG cable provides an interface between the catheter and a standard ECG monitor (via 2 mm touch-proof connectors). The scavenging hose is used to connect the CryoConsole to the hospital scavenging system.
Guidelines for Gas Suppliers to Refill the Medtronic CryoCath N2O Tank
N2O Specifications
- Description: Liquefied nitrous oxide
- Molecular Formula: N2O (UN 1070) 99.5% purity with a humidity level less than 50 ppm
- Note: Non-USP, non-medical grade
Refilling Instructions
- The refrigerant must be refilled in the supplied Medtronic CryoCath® N2O tank made of aluminum. These tanks consist of three (3) parts: cylinder, stainless steel dip-tube, and a valve.
- The gas supplier must connect to the N2O tank valve with an outlet connector model “CGA326”.
- The approximate amount of refrigerant to refill is 10 lbs..
- At each refilling, supply the hospital with a “Certificate of Analysis” showing the refrigerant meets or exceeds the specifications indicated above.
- Note: For customers refilling with AIRGAS, the part number is: NS CC10ACT50C
- Find the closest AIRGAS location near you, call: 1 (866) 924-7427 or use online locator: http://www.airgas.com/customer_service/site_locator.aspx
Contact Information
For any questions, please contact:
AF Solutions Technical Support
Toll-free: 1 (877) 464-2796
rs.yultechnicalsupport@medtronic.com
All parties handling the refrigerant tanks must be aware that tanks containing N2O refrigerant are considered dangerous goods (I.A.T.A Class 2.2 Non Flammable, Non-Toxic Gas and Class 5.1 Gases Oxidizer) and should be handled accordingly.