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.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Cryoablation catheter will not reach target temperature / weak freeze
HighSymptoms: Balloon or tip temperature not dropping to target, long freeze times, poor lesion.
Root cause: Low refrigerant (N2O) supply, a blocked catheter Joule-Thomson section, moisture / ice in the line, or a console gas-delivery fault.
Catheter connection / recognition fault
MediumSymptoms: Console does not recognise the catheter, will not arm a freeze.
Root cause: Catheter umbilical connector wear or a damaged catheter hub.
Vacuum / safety-monitoring fault
HighSymptoms: Vacuum alarm, safety interlock, freeze aborts and the catheter auto-thaws.
Root cause: Vacuum pump, a circuit leak, or a monitoring-sensor fault.
Gas-supply / scavenging fault
MediumSymptoms: Low gas-pressure alarm, or exhaust-scavenging fault.
Root cause: N2O cylinder low, regulator, or the scavenging connection.
Console / display fault
LowSymptoms: Unresponsive display, will not power on.
Root cause: Console power supply or control board.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
N2O gas cylinder / regulator
Class Frequent wear itemRel. cost $$R&R Fairly easy
In-line gas filter / drier
Class Frequent wear itemRel. cost $R&R Fairly easy
Catheter umbilical / connector assembly
Class Periodic replacementRel. cost $$$R&R Moderate
Vacuum pump
Class Periodic replacementRel. cost $$$R&R Difficult
Console control board
Class Major service partRel. cost $$$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| N2O gas cylinder / regulator | Frequent wear item | $$ | Fairly easy |
| In-line gas filter / drier | Frequent wear item | $ | Fairly easy |
| Catheter umbilical / connector assembly | Periodic replacement | $$$ | Moderate |
| Vacuum pump | Periodic replacement | $$$ | Difficult |
| Console control board | Major service part | $$$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Weak or no freeze
- This is an OEM-service ablation console - a BMET supports the console and gas system, not the sterile catheter.
- Check the N2O supply pressure and fit a full cylinder if low.
- Replace the in-line filter / drier and let the console purge.
- Confirm the catheter is recognised and fully connected at the umbilical.
- Escalate a confirmed gas-delivery or vacuum fault to Boston Scientific; coordinate with the EP team.
Symptom: Vacuum alarm / freeze aborts
- Confirm the catheter has auto-thawed and is safe.
- Check all circuit connections for a leak.
- Note the exact fault code.
- Run the console self-test / diagnostics.
- Escalate a vacuum-pump or sensor fault to Boston Scientific.
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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