Warming System

The Warming System is a forced air warming device comprising a Medical Warming Unit and disposable warming blankets. It is indicated for hypothermic patients or normothermic patients requiring induced hyperthermia or localized temperature increase. The unit features temperature settings at 43°C, 38°C, and 32°C with an LCD display and emergency alarm function.

The proposed device has the same classification, product code, indications for use, temperature settings, and general design as the predicate IOB Temperature Management System. Minor differences include slightly higher system power specifications (100-127VAC vs. 110-120V), higher heater power (1000VA vs. 950W), extended shelf life for blankets (5 vs. 3 years), and slightly different over-temperature threshold (50°C vs. 47°C). The device includes replaceable 0.2 micron air filters and secure locking hoses.

Performance testing per ASTM F1886/F1886M-16, ASTM F2096-11, ASTM F1929-23, ASTM F88/F88-23, USP<71>, and ASTM F1980. Biocompatibility per ISO 10993-1, 10993-5, 10993-10, and 10993-23. Electrical safety and EMC per IEC 60601-1, IEC 60601-1-2, IEC 60601-4-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-35, and IEC 61000-4-3.

The proposed device is substantially equivalent because it has identical indications for use, the same regulatory classification and product code, and similar design features and technological characteristics to the predicate device. Performance testing demonstrates the proposed device is as safe and effective as the predicate device, with minor variations in power and temperature thresholds that do not compromise safety or effectiveness.