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The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function. The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover. While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance."

The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

The ChillBuster® Model 8002 Portable Electric Blanket System features a special electrical resistively heated Blanket, a Controller to manage power and device function, a rechargeable Battery, special cabling, and means to connect to external DC or AC power for recharging the Battery and, at the option of the user, operating the Blanket. During therapy, the Blanket is encased in a Sterile, Single-Use Blanket Cover to prevent cross-contamination of successive patients and to prevent soiling. The device can perform therapy at virtually any interval in the following activities or activity chains: a) initial patient preparation and transport in the field, and at any stage of ER, surgery, and ICU or post-op care for injury victims from the field; b) pre-op, surgery, ICU or post-op care of in-facility patients; and c) special situations involving potential or actual hypothermia (e.g. hemodialysis; peritoneal dialysis; plasmapheresis; patient warming during transport from point to point, etc.).

The ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.

The ChillBuster® Model 8001 Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Battery, Cabling, AC Adapter, and Carrying Bag. The Blanket features a waterproof nylon outer layer, an inner layer of soft polar fleece, and a unique pattern of special thermal wire and a wire-adjacent thermistor. The Control Module contains an electronic circuit board, a User Interface Panel, Interconnect Wiring, and a Molded Chassis with a compartment for the Battery. The System uses a sealed lead acid, rechargeable Battery. Cabling includes a standard Blanket Interconnect Cable and an optional cable for connection to a vehicle cigarette lighter socket. All Systems include a standard AC-to-DC Adapter. The Carrying Bag conveys no impact on system safety.