U.S. Version

The IQool™ Warm System

IQoolTM System is a medical device for treatment of cardiac arrest and stroke. BrainCool AB has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its second product in the United States, the IQoolTM Warm System, with an indication for use of thermal regulation to cool and rewarm adult patients when clinically indicated. The new system adds important features to the company’s first product, the IQool™ System, which was cleared by the FDA in May, 2017, with the indication to cool patients using its patented anatomically-targeted temperature regulation pads.

The IQool™ Warm System is a next-generation precision surface temperature regulation system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and torso. The IQool™ Warm System quickly and effectively regulates body temperature in adult patients when clinically indicated using easy-to-apply non-stick adhesive pads prefilled with BCCOOL (a non-toxic and bacteriostatic cooling agent) that are attached to an automated temperature control unit. The IQool engages within seconds, allowing clinicians in a variety of settings to manage patient temperature quickly and effectively.

 

The IQool™ Warm System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 39.5°C. The system delivers temperature-controlled BC COOL (coolant) ranging between 4°C and 30°C through the Cooling Pads. This results in heat exchange between the BC COOL and the patient. Patient temperature is monitored by one or two patient temperature probes. The system is always ready to go since the fluid in the system BC COOL is only required to be changed once a year.

The IQool™ Warm System maintains a controlled patient temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system. The default treatment settings for temperature and time can be changed through the touchscreen monitor. Alarms and notifications are activated if any errors are detected.

Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring. After a treatment, a detailed log file can be collected with the BC STICK.

 

The patented silicone Cooling Pads are molded to ensure the best fit and are available in different sizes. Silicone is a substance that retains its properties even when chilled, and it is adaptable and tolerated by most people with only a small risk of hypersensitivity. The Cooling Pads are non-sterile, biocompatible silicone material and contain no latex. The Cooling Pads are delivered pre-filled, and no filling or purging is necessary before or after a treatment. They are designed without any adhesive connection between the pad and patient skin and can easily be lifted during treatment if the clinician or operator needs access to covered body parts. The IQool System’s Cooling Pads work independently from each other, and this provides redundancy. If one Cooling Pad malfunctions, the treatment can continue during replacement of the damaged pad. The Cooling Pads are divided into three separate cooling areas:

  • Two Cooling Pads for the torso
  • Two Cooling Pads for the thigh
  • Two Cooling Pads for the head/neck (Optional)

The IQool System does not require any rinsing or cleaning of the fluid pathway before or after use.

The IQool System has three double connections to connect Cooling Pads for the head/neck, torso, and thigh. All Cooling Pads have a uniquely keyed (Left/Right) design with internal sensors to indicate if a Cooling Pad is connected. When both the left and the right side of the Cooling Pad are connected, a green light will be shown.

The Cooling Pads can be disconnected during treatment if necessary. If all Cooling Pads are disconnected, the IQool System will pause the treatment.