SMARTFREEZE™
BOSTON SCIENTIFIC CORPORATION · Model M004CRBS400H0
A mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It typically includes a console, monitor, connection cable(s), electrocardiogram (ECG) electrodes, and a cryoablation catheter in which extremely low temperatures are achieved through expansion of a pressurized liquid refrigerant (e.g., nitrous oxide) at the catheter tip; monitoring is achieved via ECG displays and sensors within the catheter.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Cardiac cryosurgical system
- FDA product classification
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
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