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The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun™ Stat Temperature Management System is a non-invasive, thermal regulating device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The system consists of a console, non-sterile single patient use ArcticGel™ Pads, and associated accessories. The Arctic Sun™ Stat Temperature Management System circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ Pads, resulting in heat exchange between the water and the patient. A commercially available Yellow Springs Instrument (YSI) 400 series compatible patient temperature probe connected to the console provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Stat console has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun Stat Temperature Management System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6° F to 101.3°F). The system consists of the Arctic Sun Stat Control Module, associated accessories, and is used with the ArcticGel Pads. The Arctic Sun Stat Control Module and associated accessories are the subject of this submission. The Arctic Sun Stat Control Module circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient. A commercially available YSI 400 series compatible patient temperature probe connected to the Arctic Sun Stat Control Module provides patient temperature feedback to an internal control algorithm, which automatically increases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun Stat Control Module has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

The Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun Temperature Management System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The Arctic Sun Temperature Management System consists of the Arctic Sun 5000 Control Module and disposable non-sterile ArcticGel Pads. The control module recirculates temperature-controlled water to the ArcticGel Pads. A commercially-available medical temperature probe, such as naso-pharyngeal, bladder, rectal, or esophageal, connected to the control module senses the patient's core temperature. A control algorithm automatically adjusts the water temperature (automatic mode) or the clinician can adjust the water temperature (manual mode) to obtain the desired patient temperature. The ArcticGel Pads come in various sizes to cover a broad range of patients and fit both males and females. Each pad has an inlet and an outlet connection that attaches to a fluid delivery line that is connected to the Arctic Sun 5000 Control Module. Up to six pads can be connected at one time. The pads adhere to the patient by the use of a biocompatible hydrogel adhesive.

The Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun Temperature Management System is a noninvasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The Arctic Sun Temperature Management System consists of the Arctic Sun 5000 Control Module and disposable non-sterile ArcticGel Pads. The control module re-circulates temperature-controlled water to the ArcticGel Pads. A commercially-available medical temperature probe, such as naso-pharyngeal, bladder, rectal, or esophageal, connected to the control module senses the patient's core temperature. A control algorithm automatically adjusts the water temperature (automatic mode) or the clinician can adjust the water temperature (manual mode) to obtain the desired patient temperature. The ArcticGel Pads come in various sizes to cover a broad range of patients and fit both males and females. Each pad has an inlet and an outlet connection that attaches to a fluid delivery line that is connected to the Arctic Sun 5000 Control Module. Up to six pads can be connected at one time. The pads adhere to the patient by the use of a biocompatible hydrogel adhesive The Small Universal ArcticGel Pad and Neonatal ArcticGel Pad are modified versions of the current ArcticGel Pads and utilize an additional patient contacting fabric material.

The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia). Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System. The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.

The Arctic Sun Hybrid ArcticGel Pads are a modified version of the Arctic Sun ArcticGel Pads. The Hybrid ArcticGel Pad is designed to operate in two different modes, Ice Gel Mode in which is the pre-frozen pads are used as standalone devices to initiate patient cooling, and Water Flow Mode in which the pads are connected to the Arctic Sun Temperature Management System which is used to control the patient at a target temperature. These dual modes provide the opportunity for early initiation of cooling in the pre-hospital setting or the hospital emergency department followed by continued temperature management with the Arctic Sun once the ice gel is thawed. The Hybrid ArcticGel Pads are pre-frozen in a freezer operating between -3°C and -20°C (27°F and -4°F). The release liners are removed from the hydrogel adhesive, and the frozen Hybrid ArcticGel Pads are applied to the patient's skin. Between 4 and 8 pads are applied to the patient, depending on the patient's size and patient temperature reduction required. Heat from the patient is conducted through the hydrogel and pad layers into the ice gel compartment. The heat from the skin melts the ice gel. The duration of Ice Gel Mode is approximately 60 to 90 minutes from the time of application to complete melting of the Ice Gel. To convert to Water Flow Mode, pad lines are irreversibly snapped onto the inlet and outlet water ports of the Hybrid ArcticGel Pads. The pad line connectors are connected to the Arctic Sun fluid delivery line. Up to 6 Hybrid ArcticGel Pads may be connected to the Arctic Sun. Temperature controlled water from the Arctic Sun control module can then be circulated through the pad. The water passes through the water flow compartment, allowing heat to be transferred from the patient's skin across the hydrogel adhesive and into the circulating water.

The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.

The Medivance Nasogastric Tube (NGT) Temperature Sensor is a sterile, single use, disposable YSI400 series thermistor temperature probe that is designed for placement in the vent lumen of a 16 or 18 Fr Bard Nasogastric Sump or Argyle Salem Sump® nasogastric tube (or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen) for measurement of esophageal temperature.

The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.

The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 32°C to 38.5 C (89.6°F to 101.3 F). The Arctic Sun System consists of the Arctic Sun Control Module and disposable ArcticGel Pads. A patient temperature probe connected to the Control Module provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient.

The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

The Arctic Blast Intravenous Fluid Chiller is composed of two main components: a heat exchanger assembly and an adsorption cooling module. The sterile fluid path is incorporated in the heat exchange assembly, which consists of the heat exchanger, a spike with vented drip chamber at the heat exchanger inlet, and a spike receptacle at the heat exchanger outlet. Prior to activation, the heat exchanger assembly inlet (spike) is connected to a liter bag of sterile fluid, and the outlet (spike port) is connected to a standard commercially-available intravenous infusion set. The heat exchanger assembly is constructed of materials and components which are commonly used in the manufacture of commercially-available intravenous infusion sets. The cooling module provides the cooling capability of the device via an adsorption process. The cooling module does not require an external power source. The cooling process is activated by pressing a button on the module. The cooling module is fully sealed and does not come into direct contact with the sterile fluid path.

The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.

The Arctic Sun Temperature Management System is a device used to monitor and control patient temperature. It consists of single-use heat transfer pads, which are adhered to areas of the patient's skin, and a control module that circulates temperature-controlled water. The control module is connected to the pads by flexible tubing. A commercially available temperature probe connected to the control module senses the patient's core temperature. The system can control the patient's core temperature by altering the temperature of the circulating water.