Arctic Sun™ Stat Temperature Management System

Empower your team to precisely control temperature for all appropriate patients.

    The Arctic Sun™ Stat Temperature Management System offers a way to non-invasively control temperature within a narrow range for all appropriate patients. It is the technology at the heart of the BD™ TTM Solution.

    The Arctic Sun™ Stat is indicated for adult and pediatric patients of all ages.

    Work to cool

    Continuously monitors fluctuation in water temperature to help you determine when your patient may be generating heat.

    Monitor mode

    Lets you set upper and lower temperature limits to continuously monitor patients being treated with Normothermia, and alerts or automatically starts therapy when the patient's temperature exceeds the bounds.

    Wireless connectivity

    Allows you to transmit data to your EMR, with customizable outputs for patient temperature, water temperature and flow rate, therapy mode, work to cool settings, and device serial number.

    Updated ergonomics

    Offers an updated ergonomic design, based on human factor analysis of the previous generation of Arctic Sun™ System, addressing cord management, handle height and design, and screen viewing angle.

    Monitor Mode - hypothermia scenario

    • To activate Monitor Mode, select the Monitor Mode button on the upper right side of the therapy screen.
    • If the patient temperature drifts outside your prescribed parameters, the Arctic Sun™ Stat Temperature Management System will either alert you when set to manual mode or begin controlling temperature to a specified target when set to automatic mode.

    Monitor Mode - normothermia scenario

    • To start Monitor Mode, the difference between the patient temp and the target temp must be within 0.5ºC and the patient temp must be within the selected upper/lower limits.
    • When activated, Upper and Lower temperature limits will display as dotted lines above and below the target temperature on therapy graph, the flow rate status will indicate Monitoring and Monitoring message is animated on status screen.

    Indications for use

    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.

    Contraindications

    • There are no known contraindications for the use of a non-invasive thermoregulatory system.
    • Do not place ArcticGel™ Pads on skin that has signs of ulcerations, burns, hives or rash.
    • Do not remove the fabric release liner of the Neonatal ArcticGel™ Pad and expose the hydrogel.
    • Do not place ArcticGel™ Pads on immature (non-keratinized) skin or premature babies.
    • 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.
    • The Arctic Sun™ Temperature Management System is not intended for use in the operating room environment.
    • Medivance supplies temperature simulators (fixed value resistors) for testing, training and demonstration purposes. Never use this device, or other method, to circumvent the normal patient temperature feedback control when the system is connected to the patient. Doing so exposes the patient to the hazards associated with severe hypo- or hyper-thermia.

    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 edema, 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 Operator’s Manual for detailed safety information and instructions for use. Federal Law (USA) restricts this device to sale by or on the order of a physician.

    Customer service phone: 1.844.823.5433
    Urgent clinical support: 1.866.840.9776

    Medivance, Inc.
    321 South Taylor Ave., Suite 200
    Louisville, Colorado 80027 U.S.
    arcticsun@bd.com

    BD-16196