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The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and managemt of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.

The function of the Synapse Transcutaneous Electrical Stimulation Device is to apply a series of pre-programmed micro-currents of varying frequency, amplitude and duration to the patient via electrode pads. A micro-controller is used to set the current demands to a linear current controller implemented solely in hardware. The Synapse Transcutaneous Electrical Stimulation Device is oval shaped and measures approximately 7 cm wide by 4 cm high by 2 cm deep. It is activated by pressing the On/Off button. There is single set program which runs in specific sequence for 48 hours after which time the unit will turn itself off and should be replaced with another unit until the end of the prescribed course of treatment. The devices are packaged in quantities of 6 so that the total treatment duration is 12 days. The Synapse Transcutaneous Electrical Stimulation Device has an LED light which indicates operational status: unit off, treatment active, treatment dormant (waiting for next active session), or current too low (e.g., interruption during treatment due to poor skin contact of the electrodes) Only Covidien's Uni-Patch electrode series are recommended for use with the Synapse Transcutaneous Electrical Nerve Stimulator. These electrodes are cleared for marketing by the FDA and are provided with stimulating electrode hydrogel (K915333); Synapse Order Code EP84910)