Temperature management is an essential component of modern healthcare, affecting myriad physiological factors such as metabolic activity, inflammation and glucose level. Welkins’ Temperature Management System provides hospitals and emergency care givers a means of controlling patient temperature in a safe, non-invasive, and effective way across the continuum of care—from the critical minutes after an injury thru the ICU and recovery.

Combining patented, NASA-spinoff technology with battlefield-tested hardware, Welkins' FDA-cleared Systems are:

• Rapid: -2°C regional cooling in first 15 minutes
• Non-Invasive: the Headliner cools the scalp and neck without invasive (intravenous, intra-nasal or otherwise) procedures
• Easy: deployable by non-specialized medical personnel in <60 sec.
• Portable: internal battery power enables uninterrupted cooling that can follow a patient across pre- and in-hospital environments
• Reliable: housed in rugged heat- and impact-resistant thermoplastics, the System is lightweight and requires no external power during cooling

FDA-Cleared Cooling Headliner & System

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Why Welkins?

Although cooling is well-established in selected clinical conditions, most current applications use intravenous (IV) and/or whole body cooling, which have numerous drawbacks. IV cooling, once the method of choice for out-of-hospital cardiac arrest (OHCA), has been linked to significant clinical and methodological challenges such as increased risk of re-arrest, decreased artery perfusion, IV insertion error, and need for high-dose diuretics to mitigate volume overload. Whole body or systemic cooling devices, likewise, are associated with coagulation abnormalities, impaired immune function, and may easily miss the treatment window because they are not practical in the pre-hospital setting.

Welkins’ portable Temperature Management System remedies these shortcomings, enabling safe, non-invasive cooling that can be deployed by non-specialized medical personnel in the field, during transit, and throughout the hospital (ER/OR/ICU):

Cooling Headliners for Multiple Applications

The Cooling Headliner offers a safe, non-invasive method of temperature management through cooling of the head and neck (carotid triangle). Its flexible design, small footprint, and various collar designs allow uninterrupted cooling for a wide variety of procedures, without obstructing clinicians. Configurations include:

1. Integrated Cervical Collar (EMS)
2. Flex Collar (EMS, OR, ICU, Out-Patient, Athletic) - pictured with gel head pad for surgical use
3. fMRI-Safe Umbilical (Diagnostic, Research)

FDA-Cleared Indications for Use

The Welkins Temperature Management System and Cooling Headliner have passed rigorous third party testing to verify their electrical safety (per UL 60601-1 and IEC 60601-1-6), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993).  The System has been cleared by the U.S. Food and Drug Administration (FDA) with the following indications for use:

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The WElkins EMT/ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated.

Note that the safety and effectiveness of the Head-Neck Cooling Pad has not been demonstrated for treatment of stroke or head trauma, and is not indicated for use in the treatment of stroke and/or head trauma.