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General| Category | Medical Equipment |
|---|---|
| Type | Electrotherapy Patch |
| Brand | Chattanooga |
| Material | Hydrogel |
| Single Use | Yes |
The I-Bresis System is for administering soluble salts or other drugs into the body as an alternative to hypodermic injection.
Lists conditions and patient types where the I-Bresis System should not be used, including electronic devices, sensitivities, and specific body areas.
Do not use with pacemakers or defibrillators due to risk of shock, burns, or interference.
Avoid use if patient has known sensitivity to the drug, electrical current, or the solution.
Do not use on pregnant women or damaged/scarred skin due to safety concerns.
Do not apply treatment across the temporal or orbital regions of the head.
Covers warnings related to children, application across the chest or head, pain, and skin condition.
Details risks like blisters, skin reactions, electromagnetic interference, flammable anesthetics, and MRI use.
Addresses potential systemic adverse effects from delivered drugs and prohibits equipment modification.
Includes drug information, single-use policy, packaging, electrode inspection, and handling guidelines.
Discusses erythema, positive polarity with chloride ions, and general handling to avoid shock or burns.
Advises on avoiding RF interference and general system handling to prevent malfunction.
Details the I-Bresis Patch as a disposable, single-use device for drug delivery, usable with or without a controller.
Explains that drug pad polarities are labeled on the Patch for correct drug application.
Describes the two drug pads, their fill volume, and the requirement for charged drugs and chloride counter ions.
Identifies the battery pack location as the connection point for the Controller.
Explains iontophoresis using like-charge repulsion to drive ionic solutions into the skin.
Advises on potential skin irritation, erythema, and patient sensations like tingling or warmth.
Step-by-step guide on preparing the patch, including cleaning the skin and applying drug/saline solutions.
Outlines three treatment options: I-Bresis Treatment, Standard Treatment, and Patch-Only Treatment.
Details the procedure for initiating and completing an I-Bresis mode treatment using the controller.
Specifies the wear time for I-Bresis mode treatments based on mA-minutes dosage.
Provides instructions for setting up and executing treatments in Standard Mode.
Explains the process and wear times for Patch-Only treatments.
Lists the components and materials used in the I-Bresis Patch.
Covers the patch's expected life, single-use nature, and proper disposal methods.
Provides guidance for patients wearing the patch at home, including expected sensations and warnings.
Instructs on proper patch removal timing, rinsing, and disposal after use.
Describes possible skin reactions like erythema, blisters, and irritation after treatment.
Lists order numbers and descriptions for the I-Bresis Charging Station, Controller, and Patch.
Details the device classifications (e.g., Type BF Applied Part) and battery type.
Specifies environmental conditions for storage and use, and flammability considerations.
Lists supported treatment modes, physical dimensions, and weight of the patch.
Provides dose range, maximum voltage, and maximum current for the patch.
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