St. Jude Medical, Inc. EnSite Velocity
ST. JUDE MEDICAL, INC. · Model EnSite Velocity
• Facilitates procedures in all champers of the heart • Features an open platform that is compatible with almost any EP catheter and most EP lab equipment. • Provides real-time visualization and navigation of up to 128 electrodes on a combination of catheters. • The OneModel Tool enables users to create a precise model of patient cardiac anatomy in less time than previously possible. • OneMap Tool allows for the chamber model and electrical information to be collected simultaneously. • Supports both contact and non-contact mapping procedures. • Detailed model creation and a full suite of mapping tools help support a variety of treatment strategies.
Key tips
- ·Never defeat or bypass a return-electrode monitoring (REM) alarm to finish a case - it's a direct burn risk.
- ·Verify OR table battery backup - a table that loses power mid-procedure is a real, documented incident type.
- ·Track surgical light lamp-hours rather than waiting for failure - a sudden failure mid-case is avoidable.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Instrument / implant breakage
HighSymptoms: Fractured tip, loose component, debris.
Root cause: Metal fatigue, improper reprocessing, or misuse.
Reprocessing / sterilization failure
MediumSymptoms: Residue, bioburden, discoloration.
Root cause: Inadequate cleaning cycle or damaged tray.
Table hydraulic / actuator fault
MediumSymptoms: Slow or drifting positioning.
Root cause: Cylinder seal or actuator wear.
OR light LED failure
LowSymptoms: Dim or dead panel, color shift.
Root cause: LED module aging.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Table hydraulic actuator
Class Periodic replacementRel. cost $$$R&R Difficult
Instrument repair / replacement set
High-turnover consumable instruments.
Class Periodic replacementRel. cost $$R&R Fairly easy
Electrosurgical pencil & electrode
Consumable per procedure.
Class ConsumableRel. cost $R&R Easy
Return electrode (patient plate)
Single-use; expiry critical.
Class ConsumableRel. cost $R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Table hydraulic actuator | Periodic replacement | $$$ | Difficult |
| Instrument repair / replacement set High-turnover consumable instruments. | Periodic replacement | $$ | Fairly easy |
| Electrosurgical pencil & electrode Consumable per procedure. | Consumable | $ | Easy |
| Return electrode (patient plate) Single-use; expiry critical. | Consumable | $ | Easy |
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.
- ·Pre-case functional check
- ·Electrosurgical return-electrode cable inspection
- ·Table hydraulic / mechanical inspection
- ·Annual electrical safety test and full PM
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Electrosurgical electrode wear
- Confirm the presentation - typically poor cut/coag, sparking, low power - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: burned/eroded blade or pencil.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the electrosurgical pencil & electrode per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Return electrode / pad fault
- Confirm the presentation - typically pad alarm, no activation - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: poor contact or expired pad.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the return electrode (patient plate) per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Operating rooms
- Procedure rooms
- Interventional suites
Documents & Manuals
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
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