This document presents a radiation hazard assessment for the IZON AFC-V2 Automatic Fraction Controller. The device, designed for laboratory use, automates extracellular vesicle (EV) isolation. It incorporates a 13.560 MHz NFC module for identifying proprietary qEV Columns during testing. Testing was conducted with an attached qEV Column.
FCC part 15 testing, detailed in EMC Technologies NZ Ltd test report number 240314.3 dated 25th November 2024, indicates a field strength of 57.0 dBuV/m (Quasi Peak detector) at a test distance of 10 meters. This corresponds to a radiated power of -27.8 dB, equivalent to 0.00167 mW. Compliance with FCC KDB 447498 D04 and Section 2.1091 ensures that the device operates in a manner that prevents public exposure to high levels of RF energy.
Given that the device is likely to come into close contact with the human body during normal use, particularly the hand when cards are used, the assessment concludes that the device is exempt as the power level remains below 1 mW. The device is therefore compliant with relevant regulations.