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9

ADMINISTERING TREATMENTS

The I-Bresis™ System is designed to provide the following three treatment options:

I-Bresis™ Treatment

 

The Controller delivers current at 3 mA to the Patch for three minutes for a Skin Conductivity Enhancement (SCE), followed by the patient 

wearing the Patch for approximately one to two hours, resulting in a 40-80 mA-minute treatment respectively.

Standard Treatment

 

The Controller delivers current at 2, 3 or 4 mA to the Patch for 10-20 minutes, resulting in a 40 mA-minute treatment. For an 80 

mA-minute treatment, repeat the treatment.

Patch-Only Treatment

The Patch delivers low level current over 2–4 hours, resulting in an approximate 40–80 mA-minute treatment respectively.

I-BRESIS™ MODE TREATMENT

NOTE: While using the Controller, should an in-process iontophoresis treatment need to be stopped or paused, DO NOT suddenly 

remove the Controller from the Patch without first switching off the Controller. To stop a treatment while the Controller is administering 

iontophoresis, press the ON/OFF button and wait a few moments for the Controller to turn off.
NOTE: For additional information on the Controller, refer to the Controller Instructions for Use.

1.

  Push the ON button on the Controller. The Green I-Bresis™ Light will blink slowly.

2. 

Attach the Controller to the Patch. The Patch connector (located at the center of the Patch) plugs into the slot on the back of 

the Controller. Ensure that the Patch connector is fully and securely engaged into the Controller—a click will be heard upon full 

engagement.

3. 

Position the patient so that there is no pressure on the Patch during treatment.

4. 

Press the START button to begin treatment. The green I-Bresis™ Light will blink more rapidly, then glow steadily.

5. 

After three minutes, the Controller will sound a beep and the lights will turn off automatically. This indicates that the Skin 

Conductivity Enhancement (SCE) is completed.

6. 

Remove the Controller from the Patch. The Patch will now continue to deliver the remainder of the iontophoresis treatment to the 

patient.

7. 

If the patient will be wearing the I-Bresis™ Patch outside of the clinic, review the “Instructions for Home Use” at the end of this 
document with the patient, and provide the patient with a copy of those instructions, if requested.

 

6. 

Remove the adhesive release liner from the hydrated Patch.

7. 

Apply the hydrated Patch so that the drug pad is over the treatment site and secure it by pressing the adhesive border. Avoid pressing 

directly over the pads. Pressing directly on the pads can cause leakage that will compromise adhesion to the patient.

 NOTE: 

DO NOT tape or bind the Patch during treatment. Do not apply hot or cold therapy over Patch during treatment.

Summary of Contents for 5000060

Page 1: ...0060 Instructions For Use I Bresis Patch Carton Contents 6 Patches 6 Saline Ampoules 6 Alcohol Preps READ THE I BRESIS CONTROLLER AND CHARGING STATION INSTRUCTIONS FOR USE FOR ADDITIONAL IMPORTANT INF...

Page 2: ...se of WEEE as municipal waste Contact your local distributor for information regarding disposal of the unit and accessories Consult Instructions For Prescription Only Caution Federal law USA restricts...

Page 3: ...rillator or other implanted electronic device because this may cause electric shock burns electrical interference or death Drug sensitivity Do not use on patients with known sensitivity to the drug be...

Page 4: ...ent reaction to the materials in the electrodes or a poor connection between the electrode and the patient s skin Advise the patient of this possibility before starting treatment If a visible skin rea...

Page 5: ...rodes have been placed can cause poor contact between the skin and the electrode or uneven distribution of current resulting in greater risk of skin irritation Erythema A transient erythematous reacti...

Page 6: ...tments 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 Pa...

Page 7: ...ultiplying the current mA by the time min PREPARING THE PATIENT Advise the patient that iontophoresis has the potential to result in skin irritation and or burns Direct current may result in transient...

Page 8: ...s NOTE Fill volume is approximately 1 5 ml Drug pads should be saturated but not overfilled If the drug pads are overfilled beyond the saturation point the pads may leak and directly affect the adhesi...

Page 9: ...blink slowly 2 Attach the Controller to the Patch The Patch connector located at the center of the Patch plugs into the slot on the back of the Controller Ensure that the Patch connector is fully and...

Page 10: ...START button to begin treatment The Green mA Light will blink more rapidly then glow steadily 6 To change the iontophoresis current setting while the Controller is administering a treatment press the...

Page 11: ...d pets The Patch cannot be reused PATCH MATERIALS AND PH BUFFER Component Material Adhesive Material Beige polyester fabric medical grade pressure sensitive adhesive Conductive Element Polyester film...

Page 12: ...MRI scans as this may result in metal overheating and causing skin burns in the area of the Patch Handle the Patch with care Do not immerse the Patch in fluids or allow it to be connected with other e...

Page 13: ...within a few hours after treatment Avoid scratching this area Contact your clinician if this problems persists longer than 24 hours Small pinhead size blisters may develop in response to certain drug...

Page 14: ...temperatures above 50 C 122 F Flammability Do not use around flammable gasses liquids or materials Treatment Modes I Bresis Standard and Patch Only Dimensions 13 7 cm L x 6 6 cm W x 1 1cm H 5 4 x 2 6...

Page 15: ...DJO Global LLC 1430 Decision St Vista CA 92081 USA 800 336 6569 760 727 1280 14 73101 Rev B 2017 DJO LLC Inc DJOglobal com...

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