vitalHEAT vH2 Temperature Management System Questions & Answers

  1. What is the indicated use for the vitalHEAT™ vH2™ Temperature Management System?
    The vitalHEAT vH2 system is designed to noninvasively treat hypothermic patients by warming their body core. This is accomplished with local application of negative pressure and thermal load (heat) to a distal appendage.
  2. What are the contraindications for the vitalHEAT vH2 Temperature Management System? The vitalHEAT vH2 system is contraindicated for patients under the age of 18 and for patients with peripheral vascular disease.
  3. Is the vitalHEAT vH2 system FDA approved?
    The vitalHEAT vH2 system is cleared for commercial distribution by FDA acceptance of Dynatherm Medical's Section 510(k) premarket notification.
  4. Can I use the vitalHEAT vH2 system on pediatric patients?
    No. Currently the vitalHEAT vH2 system is only available for use on patients age 18 or older. Clinical validation of use on pediatric patients is planned.
  5. Can I use the vitalHEAT vH2 system intraoperatively?
    Yes. Ongoing clinical evaluations have shown that the vitalHEAT vH2 system is capable of maintaining the patient's core body temperature during surgery. The system has been used on patients undergoing the following surgical procedures:
    • Open abdominal procedures such as open colectomy
    • Gynecologic procedures
    • Plastic/aesthetic procedures
    • Urologic procedures
    • Orthopedic procedures
    • Cardiac procedures
    • Minimally invasive / laparoscopic procedures

  6. How does heating the hand/forearm warm the rest of the body?
    It is the combination of the vacuum/heat application to the hand/forearm with the patient's own hemodynamic and thermoregulatory systems that enables this technology to warm the rest of the body. The mechanical force (negative pressure/vacuum) dilates and maintains dilatation of the subcutaneous heat exchange vasculature structures underlying the skin (the arteriovenous anastomoses, or AVAs) in one hand/forearm. Once vasodilated, thermal applications to the skin overlying that hand/forearm will be transferred directly via conduction into the blood flowing through the underlying AVAs and venous plexuses. This conducted warmth then travels via the vasculature directly to the heart in the body's core where it is distributed to organs and tissues based on the individual's thermoregulatory mechanisms. This cycle is repeated with every heartbeat as long as the vacuum / heat application continues. As a result of this, the critical core regions receive the warmth faster than is likely to occur with superficial applications of heat alone.
  7. If you applied a Warming Sleeve to both hands, would it work twice as fast?
    Dynatherm clinical studies have shown the vitalHEAT vH2 system to outperform current warming methods. In theory, the greater the number of AVAs and skin surface area exposed to the combined vacuum/heat application, the greater the amount of heat transfer into the body core would be. We are working with clinicians to develop a warming appliance for the feet. Based on blood flow studies to date, application of the vitalHEAT system to the feet may provide a patient warming system with exceptional rewarming capabilities.
  8. Can the vitalHEAT vH2 system treat severe hypothermia?
    Yes. We believe this population of patients can benefit most from the vitalHEAT vH2 system. This patient population also poses the greatest challenge to rewarm. Our studies indicate that the colder the patient, the greater the "ramp up" of warming and, therefore, the return to normothermia.
  9. Does this product eliminate shivering?
    The vitalHEAT vH2 system has been shown to minimize the shivering of postoperative hypothermia in patients when measured subjectively.
  10. What is the temperature on the warming pad surface?
    Temperature on the surface of the warming pad does not exceed 42°C, per FDA requirements.
  11. What happens if the temperature in the warming pad exceeds 42°C?
    Safety controls in the Control Unit sense this and shut the heat/vacuum application off.
  12. How long has the vitalHEAT vH2 system been used on a person?
     The vitalHEAT vH2 system has been tested up to 10 hours and has shown no adverse effects.
  13. What is the amount of vacuum applied?
    The level of vacuum inside the Warming Sleeve is < -10 mmHg.
  14. Does the use of the vitalHEAT vH2 system affect blood pressure readings?
    In practice, the Warming Sleeve is most often placed on the same arm as the blood pressure cuff. Clinical studies and test data to date indicate that the vitalHEAT vH2 system has no effect on the patient's blood pressure.
  15. Are there any problems associated with the application of a low-level vacuum on the hand?
    There have been no problems identified with the application of a low-level vacuum to one extremity.
  16. How does the vitalHEAT vH2 system affect hypotensive patients?
    In our clinical experience to date, we have not seen any adverse effects from the use of the vitalHEAT vH2 system on hypotensive patients.
  17. How does the vitalHEAT vH2 system affect heart rate?
    Our clinical experience to date indicates that the use of the vitalHEAT vH2 system on the hand/forearm has had no effect on the heart rate of the patient.