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PATCH DESCRIPTION AND INTENDED USE
The I-Bresis™ Patch is a disposable, single-use Patch with an internal battery and current-limiting circuitry. It can deliver both negatively
and positively charged water-soluble drugs/compounds across intact skin. The Patch can be used with and without the Controller. The
Controller is used with the Patch to deliver an I-Bresis™ or Standard Treatment. A Patch-Only Treatment does not require the use of the
Controller.
The Patch is and Applied Part that is intended to deliver energy and ions (charged atoms or molecules) across the patient’s skin. The Patch
is a prescription device in the USA. The clinician is responsible for selecting the appropriate drug and treatment site for the condition
being treated. The Patch is intended to be applied in a clinic or hospital setting by the clinician. I-Bresis™ and Standard Treatments that
use the I-Bresis™ Controller are intended to occur in a clinic or hospital setting for the time that the Controller is attached to the Patch.
The Patch itself is designed for home use. The Patient may wear the Patch out of the clinic for Patch-Only or I-Bresis™ Treatments. At the
discretion of the clinician, Patches may also be sent home with the patient for future treatments.
Drug Polarity Labeling
The polarities of the drug pads are labeled on the Patch.
Patch Drug Pads
The Patch has two drug pads. Each drug pad has a ~1.5 ml fill volume. Use negatively charged water-soluble drugs/
compounds on the negative (-) drug pad and positively charged water-soluble drugs/compounds on the positive (+) drug
pad. For (+) polarity, use only drugs with Chloride (Cl-) Counter Ions.
Battery Pack and Controller Connector
The Battery Pack that contains two 3-Volt batteries is also the connecting location for the Controller.
Patch Battery
Compartment
Connector for
Controller
Removable Liner
Positive
Drug Pad
Negative
Drug Pad
Patch Top Patch Bottom Patch with Controller
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