Experimental description

0030-EX-PL-2007 Text Documents

AJ Medical Devices

2007-01-29ELS_79461

Form 442 Page 1

PROPOSED EXPERIMENTAL OPERTATION

Premise of the Experimentation.

AJ Medical Devices (“AJ Medical”) herein supplements its application for
new experimental authority with the following detailed information regarding
its proposed operations. AJ Medical seeks authority to operate 36 unique
Medical Implant Communications Service (MICS) devices. As intentional
radiators, MICS devices are not permitted to operate under the Commission’s
rules, even for the purposes of testing and demonstration, absent an equipment
authorization. Accordingly, AJ Medical herein seeks permanent experimental
authority to permit it to operate the devices at commercial and residential
environments with human and dog subjects in the states of Illinois and
Minnesota as described below. 1

AJ Medical’s request for experimental authority is supported by good
cause. AJ Medical has entered a new phase in the development of a cardiac
arrest monitor and alarm that detects ventricular fibrillation or asystole and
transmits an alarm signal and ECG. The unit comprises 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 implant’s
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 use its medical implant and
associated receiver devices for up to 24 months in clinical trials wherein patients
will be ordered by their physicians to test the transmission through weekly
magnet-activation of the implant’s 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.

1The Commission has previously authorized AJ Medical to operate its experimental devices on
an STA basis. Owing to a re-commitment of its funding, AJ Medical is herein seeking permanent
authority to operate its devices in a fashion nearly identical to its previously approved STA
operations. (See File Nos. 0348-EX-ST-2005 and 0713-EX-ST-2005.)

Form 442 Page 2

The devices operate at extremely low power of just 25 uW. AJ Medical
will be operating its devices only in the laboratory setting or under physician
supervision at locations in Illinois and Minnesota.

AJ Medical is performing these experimental operations in anticipation of
filing an application seeking authority under the Commission’s equipment
authorization rules in the future. Additionally, AJ Medical requires the feedback
from its experimentation in order to supplement its applications before the Food
and Drug Administration, which also must approve of the use of MICS devices.
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.

Details of operation:

AJ Medical is a manufacturer of MICS devices and seeks authority to test
36 unique devices in different environments: 12 devices are proposed for use in
AJ Medical’s laboratory facilities for testing; 12 devices will be used to transmit
from dogs in medical facilities; and 12 devices will be used to transmit from
human patients who will be working with their physicians in medical facilities
and their respective residential environments. In all phases of use, the devices
are operated on a single MICS frequency at extremely low transmitting power
within a small radius around the body and worn against the body. Accordingly,
and given the characteristics of the devices and the relatively small testing
sample, AJ Medical asserts that there is no potential for interference with other
devices in the adjacent spectrum.

Document Created: 2007-01-29 15:18:03
Document Modified: 2007-01-29 15:18:03

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