Indications for Use: The Arctic Sun® Temperature Management System is intended for monitoring and controlling patient temperature.

Contraindications

  • There are no known contraindications for the use of a thermoregulatory system.
  • Do not place ArcticGel™ Pads on skin that has signs of ulcerations, burns, hives or rash.
  • While there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities.

Warnings

  • When using the Arctic Sun® Temperature Management System, note that all other thermal conductive systems, in use while warming or cooling with this device may interfere with patient temperature control.

Cautions

  • Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy. Examine the patient’s skin under the ArcticGel™ Pads.
  • Skin injury may occur as a cumulative result of pressure, time and temperature.
  • Carefully remove ArcticGel™ Pads from the patient’s skin at the completion of use. Aggressive removal or removal of cold pads from the patient’s skin may result in skin tears.
  • The rate of temperature change and potentially the final achievable patient temperature is affected by many factors. Treatment application, monitoring and results are the responsibility of the attending physician. If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low or high water temperatures for an extended period of time which may increase the risk for skin injury.

Please consult package insert for more detailed safety information and instructions for use.