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Indications, Safety, and WarningsIntended useThe console is intended for use with compatible Medtronic cryoablation catheters. The CryoConsole™ (the console), together with its components and specified catheters, is for use in performing cardiac ablation procedures. While in CryoAblation™ mode, the console causes the cooling segments of catheters to reach cryoablation temperatures sufficient to cause tissue necrosis. During a procedure, pressurized liquid N₂O (nitrous oxide) refrigerant is injected from a tank in the console. The refrigerant travels through an ultra-fine tube, which passes through the coaxial umbilical cable and the catheter shaft to the cooling segment of the cryoablation catheter. Inside the cooling segment of the cryoablation catheter, the liquid refrigerant evaporates as it is released out of the injection tube. As the liquid evaporates, it absorbs heat from the tissue around the catheter cooling segment, cooling the tissue. The warmed vapor returns to the console through a lumen within the shaft of the catheter and the coaxial umbilical cable. This lumen is maintained under a continuous vacuum. The console evacuates the vapor into the hospital suction or evacuation system.Each catheter used with the CryoConsole™ requires different settings for operations. Therefore, the data for each catheter is stored in a catheter file. When a catheter is approved for use with the CryoConsole™, the associated catheter file is installed on the system.ContraindicationsSee the technical manual for the catheter being used.Warnings and precautionsThese warnings apply in general to using the console for cardiac cryoablation. Refer to the technical manual for console-compatible catheters for more information related to catheter use.

Cryoadhesion — Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury.

Improper connection — Do not connect a cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF energy. Doing this may cause catheter malfunction or patient harm.

RF ablation — Before powering up an RF generator or applying RF energy, disconnect the cryoablation catheter from the console to avoid an error message and unnecessary catheter replacement.

Do not resterilize a single-use device for purpose of reuse. Resterilization may compromise the structural integrity of the device or create a risk of contamination from the device that could result in patient injury, illness, or death. Single-use devices are intended only to be used once for a single patient. Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the console and catheters or patient injury or death may occur. Use only Medtronic cryoablation catheters and components and Medtronic-provided refrigerant tanks with the console. If the sterile packaging or catheter is damaged, do not use the catheter. Do not use a catheter if it is kinked or damaged.Cryoablation procedures should be performed only in a fully-equipped facility. This equipment should be used only by or under the supervision of physicians trained in cryoablation procedures. The catheter tip and rings provide a low-impedance pathway to the heart. Static electricity applied to the heart may induce arrhythmia or affect patient health. Failure to follow electrostatic discharge (ESD) precautionary procedures may cause console malfunction. If a catheter handle or coaxial and electrical connectors are exposed to fluids or solvents, the cryoablation system may not function properly, and connector integrity may be compromised. Disconnect the catheter’s electrical connection prior to cardioversion/defibrillation. The console meets the requirements of IEC 60601-1. It is the user’s responsibility after installation to verify and ensure that the console meets the applicable local electrical safety requirements. Minimize exposure to nitrous oxide to prevent short-term behavioral and long-term reproductive health effects.Potential complicationsSee the technical manual for the catheter being used.Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.MAJ_83945

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