Cincinnati Sub-Zero · Model Blanketrol III
Preset-Variable and Programmable Variable Gradient temperature selection is available in both heating and cooling mode which allows for rapid or gradual patient temperature management control. A new feature, SMART mode, associated with the term gradient setting is to have the ability for the BIII to adjust the gradient temperature settings of 5°C should you not reach your desired patient temperature within 30 minutes. The Blanketrol III continues to monitor and adjust temperature every 30 minutes until your desired patient temperature is reached.
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.
Symptoms: No heat, overheat alarm.
Root cause: Element or thermal fuse failure.
Symptoms: Setpoint error, alarm.
Root cause: Sensor aging.
Symptoms: Uneven warming, hotspot.
Root cause: Blower wear.
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.
Common R&R.
Consumable per patient.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Heating element / thermal fuse Common R&R. | Periodic replacement | $$$ | Moderate |
| Blower fan | Periodic replacement | $$ | Fairly easy |
| Temperature probe Consumable per patient. | Periodic replacement | $ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.
During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.
The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution.
The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
Ask Bio →