The following report was commissioned by Neurotron, Incorporated to evaluate claims made by Neuro Diagnostic Associates (NDA) that its Medi-Dx 7000 performs a neurodiagnostice procedure functionally equivalent to the procedure performed by Neurometer® CPT devices. Neurotron supplied Neurometer® CPT/C device (#C119809137) and Medi-Dx 7000 (#01533) for the purpose of this evaluation. The appendices contain detailed test results, summaries of findings and procedural documentation.

Eastern Tech Manufacturing Corporation 9693 Gerwig Lane Columbia, MD 21046 (410) 381-0433 Client Neurotron, Incorporated; 1501 Sulgrave Ave. Ste 203; Baltimore, MD 21209 Evaluating Engineer Lawrence Seiler President, Founder and Owner of Eastern Tech Manufacturing Company Masters Degree in Electrical Engineering from Johns Hopkins Univ. (1982) Project Neurotron, Incorporated supplied a Neurometer® CPT/C device (Serial# C119809137) and a Medi-Dx 7000 device (Serial# 01533) in order to examine claims made by NDA, the manufacturer of the Medi-Dx 7000 device, that their device performs diagnostic procedures that are functionally identical to procedures performed with the Neurometer® CPT/C device, and as a consequence all research conducted with the CPT/C device applies equally to the Medi-Dx 7000 device as well. The Neurometer® CPT/C is a medical device (manufactured by Neurotron, Inc.) which produces three specified frequencies (2000 Hz., 250 Hz., 5 Hz.) of sine wave electrical stimulation which are applied to the skin of a patient in order to measure sensory nerve function. It produces a constant current output across a range of intensities from 0.01 mA to 9.99 mA. (mA = milliamperes). The amount of the electrical current delivered by the device at each frequency is the data which is used to evaluate patients. Conclusions Note: Appendices 1-4 present the detailed results of the tests conducted on each device that form the basis for this report. Stimulus Waveforms Each device produces completely different types of waveforms at all three stimulation frequencies. The Neurometer® CPT/C produces sine waves at the 2,000 Hz, 250 Hz. and 5 Hz. frequency settings. The Medi-Dx 7000 does not produce a sine wave at any of the three settings. It produces an undefined waveform at the 2000 Hz. setting (see Fig. 2, pg. 5), a square waveform at the 250 Hz. setting (see Fig. 6, pg. 7) and an undefined asymmetric waveform at the 5 Hz. setting (see Fig. 10, pg. 9). Stimulus Frequencies Each device has settings for producing a 2000 Hz., 250 Hz., and a 5 Hz. stimulus. The Neurometer® CPT/C emits a 2000 Hz., 250 Hz. and 5 Hz. frequency stimulus in conjunction with its settings. The Medi-Dx device did not produce stimulation frequencies identical to the Neurometer® CPT. The Medi-Dx produces a 2000 Hz. with a secondary 173 Hz. frequency stimulus at the 2000 Hz. setting, a 173 Hz. frequency stimulus at the 250 Hz. setting, and a 4.3 Hz. with secondary 2000 Hz. and 173 Hz. frequency components at the 5 Hz. setting. (see Appendix 1) Constant Current Output The Neurometer® CPT/C produces a constant current output which delivered the specified amount of current across the entire range of frequencies, intensity settings and loads in a series of twelve tests. The Medi-Dx 7000 does not produce a constant current output and was unable to deliver the specified amount of current in any of the twelve tests conducted. (see Appendix 4) Summary There is no apparent basis for claims made by the manufacturer of the Medi-Dx 7000 that their device does perform or is capable of performing tests which are functionally identical to tests performed with the Neurometer® CPT/C device. There was no correlation found between the stimulus waveforms, the stimulus frequencies, the current output levels or the accuracy of the two devices in any of the twelve tests conducted on each device. Appendices (Click on links to view.) Appendix 1. Summary of Stimulus Output Comparison Test Results From the Neurometer® CPT/C and the Medi-Dx 7000. Appendix 2.  Directory of Stimulus Output Comparison Tests Conducted Over a Range of Loads, Frequencies and Intensity Output Settings. Test 1:  2000 Hz.  1.50 mA.  5K Ohms Test 2:  2000 Hz.  9.99 mA.  5K Ohms Test 3:  250 Hz.  1.50 mA.  5K Ohms Test 4:  250 Hz.  9.99 mA.  5K Ohms Test 5:  5 Hz.  1.50 mA.  5K Ohms Test 6:  5 Hz.  9.99 mA.  5K Ohms Test 7:  2000 Hz.  1.50 mA.  10K Ohms Test 8:  2000 Hz.  9.99 mA.  10K Ohms Test 9:  250 Hz.  1.50 mA.  10K Ohms Test 10:  250 Hz.  9.99 mA.  10K Ohms Test 11:  5 Hz.  1.50 mA.  10K Ohms Test 12:  5 Hz.  9.99 mA.  10K Ohms Appendix 3.  Deviation of the Actual Current Output From Each Device's Intensity Settings. Appendix 4.  Ability of Each Device to Maintain a Constant Current Output into 5K and 10 K Ohm Loads. Appendix 5.  Data Acquisition Board Specifications. Appendix 6.  Attenuation Circuit Diagrams.