
Cincinnati Sub-Zero · Model Heat Therapy Unit
Variety of safety alarms Self-calibrating microprocessor Select temperatures in 1°C increments.
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.
Symptoms: Traction force not applied, CPM carriage will not move or stalls, drive assist weak, motion one direction only.
Root cause: Worn drive motor / leadscrew / actuator, a hand-control fault, or a control-board fault.
Symptoms: Set traction force or CPM angle not reached, load cell drifts, carriage overshoots or stalls short.
Root cause: Load-cell / position-sensor drift, a potentiometer fault, or a limit-switch fault.
Symptoms: Hand control unresponsive, the patient stop / reverse button does not work.
Root cause: Worn hand control or a damaged cable.
Symptoms: Rough or noisy travel, play in the carriage, frayed traction cord or rope.
Root cause: Worn bearings / slides or a frayed cable / cord.
Symptoms: Will not power on, short battery run time.
Root cause: Power supply / fuse or an aged battery.
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.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Drive motor / leadscrew / actuator | Major service part | $$$ | Difficult |
| Load cell / position sensor / potentiometer | Major service part | $$ | Moderate |
| Hand control | Periodic replacement | $$ | Fairly easy |
| Bearings / slides / traction cord | Periodic replacement | $$ | Moderate |
| Power supply / fuse / battery | Major service part | $ | Moderate |
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 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.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
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.
Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori
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.
Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.
Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
There is the potential that the power switch assembly can dislodge from the cabinet during use.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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