Cardioblate® CryoFlex™

Argon Gas Specifications
Cardioblate® CryoFlex
™
surgical ablation system
Guidelines and Specifications for Argon Gas with the
Cardioblate® CryoFlex™ Argon-Powered Surgical Ablation System
The Cardioblate CryoFlex Argon-Powered Surgical Ablation System uses argon refrigerant for rapid ablation.
Argon gas and tank must meet the following specifications for proper function of the Cardioblate CryoFlex
Argon-Powered Surgical Ablation System.
Argon Gas Specifications
Argon Grade
North America Prepurified Argon > 99.998% pure (grade 4.8)
(Maximum acceptable level of impurity: 20 ppm)
Tank Pressure
6000 psi
310 Bar/31,000 Kpa
Tank Volume
~ 50 liters
50 liters
Tank Diameter
10 inches
25.4 cm
Tank Height*
56 inches
122 cm
Europe
Prepurified Argon
> 99.998% pure (grade 4.8)
Tank Valve Fitting
CGA677 or CGA680
CEN 1 (Argon)
W30 mm x 2 mm
Cryo Time per Cylinder
~ 35 minutes
~ 70 minutes
www.medtronic.com
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888
E-mail: [email protected]
The Cardioblate CryoFlex Surgical Ablation System
Indications for Use: is intended for minimally invasive cardiac surgical procedures, including the treatment
of cardiac arrhythmias. The Cardioblate CryoFlex 7cm, 10cm, and 10-S probes plus the Cardioblate CryoFlex
Clamp and Cardioblate CryoFlex Surgical Ablation Console freeze target tissue and block the electrical
conduction pathways by creating an inflammatory response and cryonecrosis. Contraindications: The
Cardioblate CryoFlex Surgical Ablation Probe is not designed for use inside a beating heart. Adverse Events
or Complications: Potential adverse events with this device are similar to other cardiac surgery procedures
and may include the following: Bleeding; re-operation; extension of extracorporeal bypass; heart rhythm
disturbances (atrial and/or ventricular); effusion; pericarditis; cardiac tamponade; pleural effusion;
mediastinitis; conduction disturbances (SA/AV node); acute ischemic myocardial event; thrombus formation;
low cardiac output; stroke; renal, gastrointestinal or respiratory complications; sepsis; adjacent structural
damage; and death.
• Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury. Perioperative heart
rhythm disturbances (atrial and/or ventricular)
• Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial
stenosis. It is unknown whether Cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will
have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact
with coronary vessels during Cryoablation.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete
listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for
Use which accompany each product.
Cardioblate is a registered trademark of Medtronic, Inc. CryoFlex is a trademark of Medtronic, Inc.
UC201105524 EN © Medtronic, Inc. 2011. All Rights Reserved. Printed in USA
*Includes cylinder cap and valve
Note: When the tank depletes to 3,000 psi/210 Bar/21,000 Kpa, it is no longer useful and should be changed.
Argon gas tanks are refilled by local gas suppliers of the hospital’s choice.