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When affixed to a medical device by a health care provider (user), the HEATmarker™ Time-Temperature Indicator (TTI) is indicated, via a permanent color change, for the purpose of distinguishing between medical devices that have exceeded a selected timetemperature profile of interest to the user from devices that have not exceeded that profile.

The HEATmarker™ TTI monitors the temperature history over time for any medical device to which it is affixed. The TTI can be used to monitor the heat exposure of devices at the unit package level. The TTI is constructed similar to a label that allows it to be permanently affixed to a medical device, or to the medical device packaging. The visible surface of the TTI contains an area of color-changing ink surrounded by an area of fixed color. The TTI varies in color from start point (light) to end point (dark), defined as the time when the inner, active area reaches the same color as the fixed reference area. TTIs are categorized by the length of time at a specified temperature until end point is reached, for example, 3 months at 5°C.