 The ThermaCoolT system is a unique monopolar capacitive
radiofrequency (CRF) device. The differentiating factor
between the ThermaCool system and other RF devices is a
capacitive coupling electrode, one of the company's core
patents. Through capacitive coupling, deep, uniform and
volumetric heating is deployed to tighten and contour both
the skin and underlying tissue, while concurrently applying
cryogen cooling to protect the epidermis. The result is a
non-surgical, non-laser, user-friendly device that
consistently provides:
- Immediate collagen contraction
- Long-term collagen remodeling
- Controlled volumetric tissue heating
- Concurrent cryogen cooling to protect the epidermal
surface
- Controllable dermal heating depths
- No patient recovery time following outpatient
treatment
The ThermaCool system for tissue tightening and
contouring is approved for cosmetic/aesthetic use based on
research data from a U.S. clinical trial that enrolled 86
patients treated by 6 leading aesthetic procedure centers
across the country and a retrospective study evaluating
safety and efficacy of full face treatment.
The ThermaCool System includes 5 major components:
This powerful generator produces a 6-megahertz
radiofrequency signal that can be directed to targeted
tissue. The RF generator is regulated by a compact,
Pentium-based, on-board computer capable of rapidly
processing a high volume of treatment feedback from the
handpiece assembly, including temperature, treatment
application force, tissue contact, and information on the
radiofrequency interaction with tissue.
The generator itself is simple and efficient to operate;
controls are within easy reach and important user
information is clearly displayed on the built-in video
monitor -- including energy delivered, tissue impedance,
radiofrequency on-time, and even feedback on procedure
technique.
The handpiece contains an advanced computer logic board
that processes information about skin temperature and
contact, treatment force against the skin, cooling system
function and other important data. A precision control valve
within the handpiece meters the delivery of cryogen, which
cools and protects the epidermal surface.
ThermaTip delivery device contains the patented
technology components that transform radiofrequency energy
into a controlled, volumetric tissue heating source with
simultaneous surface cooling.
- To achieve simultaneous heating and cooling, the
coupling surface transmits RF energy to the skin while
serving as a contact cooling membrane for the spray
cryogen. The contact membrane continually monitors skin
surface temperature to protect the epidermis.
- The ThermaTip device is available in several
configurations of firings, size and depth for efficient
implementation of optimal treatment guidelines.
- Uniquely engineered tip-to-skin detection technology
permits delivery of RF energy only if all four corners
of the ThermaTip device are in contact with the skin's
surface. This facilitates the safe delivery of RF energy
(heat) into the tissue.
- To further support patient safety and physician
confidence, each ThermaTip device is sterilized prior to
shipment and, through a unique electronic enforcement
system, can only be utilized as a single-patient-use
item.
The cooling module houses environmentally safe cryogen
coolant that is metered by a precision valve within the
handpiece and controlled by on-board microprocessors in both
the generator and the handpiece. Surface cooling is maintained
throughout treatment as cryogen is sprayed onto the cooling
membrane of the ThermaTip device. Precision monitoring
features are incorporated into the system to ensure that
cryogen is always available to cool the skin to desired
temperatures.
Each 15 oz cryogen canister can be used for an average of
5-6 procedures depending on the total skin surface area
treated and the ThermaTip device used.
In addition to the single-patient-use ThermaTip device,
each patient will require his or her own return pad. The
return pad is adhered to the patient's lower back to allow a
path of travel for the radiofrequency current back to the
generator. Proprietary coupling fluid, a viscous liquid that
helps ensure electrical and thermal contact with the ThermaTip
device, is also packaged in single-patient-use quantities.
Easy to use, safe and proven effective, the ThermaCoolT
system is versatile and upgradeable. The key advantage of the
ThermaCool system over other systems is its single-platform
flexibility. Interchangeable ThermaTipT options allow for
flexibility in customizing individual treatments. With a
simple change of treatment tips, Thermage® enables you to go
from a very small to a very large treatment area. Additional
treatment tips now in development will allow for even greater
flexibility in customizing individual treatments.
Patient safety is built into every ThermaTip device. Each
single-patient use tip is sterilized and programmed using a
read-only memory chip to optimize system performance and
safety. With each touch to the skin the tip uniformly
distributes capacitive radiofrequency (CRF) energy across the
entire tip surface while simultaneously protecting the outer
layer of the epidermis with cooling. An epidermal temperature
sensor within the tip constantly monitors the tissue's surface
temperature while a four-corner tip-to-skin contact system
ensures the tip is seated accurately on the skin prior to
delivering the CRF energy.
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