Prescriptive Information


Indications for Use:

The Arctic Sun® Temperature Management System is intended for monitoring and controlling patient temperature within a range of 32°C and 38.5°C (89.6°F and 101.3°F).


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.


Cautions

• Federal law restricts this device to sale by or on the order of a physician.

• This product is to be used by or under the supervision of trained, qualified medical personnel.

• The clinician is responsible for determining the appropriateness of use of this device and the user-settable parameters, including water temperature, for each patient.

• For small patients (≤30 kg) it is recommended to use the following settings: Water Temperature High Limit ≤40°C (104°F); Water Temperature Low Limit ≥10°C (64.4 °F); Control Strategy =2. It is recommended to use the Patient Temperature High and Patient Temperature Low alert settings.

• 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 or steroid or high dose vasopressor therapy. If accessible, examine the patient's skin under the ArcticGel™ Pads often; especially those patients at higher risk of skin injury.

• Skin injury may occur as a cumulative result of pressure, time and temperature. Do not place bean bags or other firm positioning devices under the ArcticGel™ Pads. Do not place any positioning devices under the Pad manifolds or patient lines.

• Do not allow urine, antibacterial solutions or other agents to pool underneath the ArcticGel™ Pads. Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion. Replace pads immediately if these fluids come into contact with the hydrogel.

• Do not place ArcticGel™ Pads directly over an electrosurgical grounding pad. The combination of heat sources may result in skin burns.

• 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 ArcticGel™ Pads are non-sterile for single patient use only. Do not place pads in the sterile field. If used in a sterile environment, pads should be placed according to the physician's directions, either prior to the sterile preparation or sterile draping.

• Do not reprocess or sterilize.

• Use Pads immediately after opening. Do not store pads in opened pouch.

• Do not allow circulating water to contaminate the field when lines are disconnected.

• The ArcticGel™ Pads should not be punctured with sharp objects. Punctures will result in air entering the fluid pathway and may reduce performance.

• If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.

• The ArcticGel™ Pads are only for use with an Arctic Sun® Temperature Management System.

• The water content of the hydrogel affects the pad's adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature. Periodically check that pads remain moist and adherent. Replace pads when the hydrogel no longer uniformly adheres to the skin. Replacing pads at least every 5 days is recommended.

• If needed, place defibrillation pads between the ArcticGel™ pads and the patient's skin.