Please explain in the area below why an STA is necessary:
AJ Medical Devices (AJ Medical), in accordance with Section 5.61 of the Commissions rules, herein seeks Special Temporary Authority (STA) for a period of six (6) months to operate 36 unique Medical Implant Communications Service (MICS) devices. As intentional radiators, albeit at very small power levels, MICS devices are not permitted to operate under the Commissions rules, even for the purposes of testing and demonstration, absent an equipment authorization. Accordingly, AJ Medical herein seeks experimental STA to permit it to operate the devices at commercial and residential environments with human and dog subjects in the states of Illinois, Indiana, and Wisconsin as described below.
AJ Medicals request for STA is supported by good cause. AJ Medical is in the early stages of developing a cardiac arrest monitor and alarm that detects ventricular fibrillation or asystole and transmits an alarm signal and ECG. The unit will comprise of two elements. The first element is an implanted patient monitor containing a transceiver that transmits automatically in the event of a medical emergency, and by patient activation for non-emergency and system testing, to a second device, which is an external transceiver (pocket receiver) located within a few meters of the patient. The pocket receiver itself receives the transmission from the implant and, in return, transmits to it, for programming and for activating the implants transmission in the patient activation mode. Clear channel access scanning is performed by the pocket receiver before it transmits to the implant to enable its transmission in the patient-activated mode.
AJ Medical herein seeks authority to initiate use of its medical implant and associated receiver devices in clinical trials wherein patients will be ordered by their physicians to test the transmission through weekly magnet-activation of the implants alarm function. AJ Medical will also be testing the devices in its laboratories and in medical facilities with dogs in order to gather additional feedback regarding system functionality and efficiency. The information garnered from the operation of these devices will permit AJ Medical to improve performance of the devices, enabling the company to continue to make modifications to its MICS chips before brining them to full production. Furthermore, AJ Medical is performing these experimental operations in anticipation of filing an application seeking authority under the Commissions equipment authorization rules in the future. To this end, and given the incredible health benefits that are afforded from early detection of heart-related events, AJ Medical maintains that this request is in the public interest.
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