DESCRIPTION OF THE PRODUCT

The product is known as The Driver Resonator. The device relates to a muscle stimulation apparatus (or) appliance in a clinical- or household situation.

The device is externally powered by one 15 – 18 Volt converter from 230 Volt or 110 Volt (internally switching) which is rectified to 12 -15 Volt DC and generates a waveform comprising of variable-frequency, biphasic, DC offset square wave pulses with safe output parameters, since it may be used in domestic situations, i.e. use without medical supervision.

The Driver Resonator has current regulating circuitry, which regulates the output of the Driver Resonator with a maximum output of 5 ma. The series connection between the current regulating circuitry and the voltage source is provided for use with the patient’s body via the output terminals of the device.

When the device is operative and with the output terminals connected via applied leads to human body contact electrodes. The biphasic DC offset pulses have the effect of stimulating the body to release neuro-hormones and neurotransmitters in some of the frequencies generated by the resonator. Other frequencies stimulate detoxification and also electromagnetic-field-boosting of the human body. Some of the frequencies have the effect of resonating pathogens to the effect of their elimination from the human body.

Rationale for classification

According to Rule 9 (Annex IX of the Council Directive 93/42/EEC), the device is designed to be classified as a Class IIa medical device, since the device exchanges energy to the body in a non-hazardous way.

INTENDED USE OF PRODUCT

According to the intended use of the Driver Resonator, unless otherwise stated elsewhere, the device may be used in the household situation without medical supervision.

In the household situation it is most likely that the patient/user will be alone in using the device and that the user will not have been provided with any or little tuition in its use, other than that provided in the User Guide.

The intended use of the Driver Resonator includes the following

• Stress relief.
• Enhanced energy.
• Pathogen removal.
• Bone growth stimulation.
• Increased sense of well-being.
• Auxiliary in pain management.
• Relaxation of muscle spasms.
• Increased local blood and lymph circulation.

WARNING

Take note that the device was neither tested on pregnant women nor on children under the age of 12 years.

Patients/ users with electronic implants such as heart-pacemakers, undergoing radiation therapy or that suffer from epilepsy, cannot use the device.

Patients/ users with internal spinal braces may experience pain as the bone begins to re-grow.

The device is however safe to use on patients who have had knee, hip or any other prostheses or medical implants (except pacemakers).

Patients/ users are advised to take a pro-biotic culture after treatment.

The device should not be used during thunderstorms.