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The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient the comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperatur management system can be used with adult and pectratr patients.

The Bair Hugger temperature management system consists of: - · a portable forced-air temperature management unit (200, 500, or 700 series), - · a disposable Bair Hugger forced-air blanket (various models), and - · the Model 459 patient cooling set (new disposable component of the system). The temperature management unit delivers warmed or room-temperature air directly to a Bair Hugger blanket via a flexible hose, or it delivers room-temperature air to the Model 459 patient cooling set, which, when filled with common ice, cools the air before delivering it to a Bair Hugger blanket. Depending on the blanket model used, the blanket is placed around, over, or underneath the patient. Small perforations in the patient-side of the blanket disperse the air over the patient. The new disposable Model 459 patient cooling set consists of an ice receptacle (flexible plastic bag) with an attached flexible hose assembly. The patient cooling set also has a handle to allow hanging it on an IV pole or similar stand near the temperature management unit. The ice receptacle has: - · a hose port that accepts the hose of a Bair Hugger® temperature management unit, - · a resealable opening for adding and retaining ice, - · a valve for draining meltwater, and - · an integral divider that directs the flow of room-temperature air from the temperature management unit through the ice, which cools the air to a temperature ranging between 3.5℃ and room temperature, as required.

The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.

The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery charger, temperature control unit, warming card, and a clean dressing called a wound cover that supports the warming card and holds it away from the wound and skin. The wound cover is a disposable, single-patient-use wound dressing. It is comprised of a thin shell, a window, and a foam frame. The shell has an adhesive border to hold the wound cover in place. It is water-resistant and can be easily cleaned. A clear window in the center of the wound cover allows the caregiver to view and assess the wound, and a pocket on top of the window holds the warming card used during warming therapy. The foam frame absorbs wound fluid (exudate), and keeps the pocket above the wound surface so neither the window nor the warming card contact the wound.

The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

The Bair Hugger Blood/Fluid Warmer consists of a warming device and a disposable set. The warming device is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 500 ml/min. The Bair Hugger Blood/Fluid Warmer can deliver temperatures as high as and including 42°C, (temperatures in accordance with the American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services). Two types of sterile disposable sets are available. The disposables are composed of the same materials used in the predicate devices. The fluid warming bag, attached to the disposable set, is placed inside the warming device and contacts heated aluminum plates. Blood, blood products, and liquids pass through the warming bag and are heated as they flow through. The warming device controls the temperature of the aluminum plates, which are heated by means of electrical resistance. The device meets the requirements of UL 2601, IEC 601-1, and EN 60601.

The Bair Hugger® Model 630 Cardiac Blanket is intended to be used to warm adult patients during cardiac surgery.

The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System® - Modification. The Model 630 Cardiac Blanket is constructed of the same materials as the Model 525 Blanket and other blankets currently on the market.

The Augustine Medical Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.

The wound care system is comprised of a power supply/battery charger, heater control unit, heater card, and a sterile dressing/bandage called a Wound Cover which supports the heater card and holds it away from the wound and skin. The Wound Cover is a disposable, single-use, sterile, non wound-contact dressing. The Wound Cover may be used either as a stand-alone wound dressing or as part of the Augustine Medical Wound Care System. The Wound Cover incorporates a clear or opaque window. The clear window allows the caregiver to view and assess the tissue. The Wound Cover surrounds and protects the wound, absorbs wound exudate and allows active warming of the periwound area by the application of radiant heat. The warming components of the system include a thin heater card, a control unit, and a power supply/battery charger. The system operates on standard wall outlet electricity or the self-contained batteries. The heater card is sized appropriately to the Wound Cover and attaches easily over the clear window of the Wound Cover. The heater card does not contact the wound and is intended for single patient use. The control unit incorporates temperature safety limits.

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The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification.

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The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit.