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Drug Information 

– Consult directions for the use of the drug/compound before delivery. Some drugs/compounds require a 

specific polarization for use. Observe the indications, contraindications, warnings and precautions related to this issue.

• 

Single Use

 – Do not use electrodes that have been previously used. These patches have been designed for single use only. 

Reuse may cause burns to patient.

• 

Packaging Information 

– Inspect the electrode packaging before use.  Do not use electrodes past the Best If Used By date 

printed on the packaging.  Do not use electrodes if the packaging is not sealed.  The electrodes may not be as effective if they 

are used past the Best If Used By Date or if they have been exposed to high humidity for an extended period of time.

• 

Electrode Inspection

 – Inspect the electrodes before use. Discard any electrode that shows signs of alteration or damage, as 

these electrodes may not be safe for use.

• 

Excessive Motion

 – The electrodes can be worn during normal activity. However, excessive motion where the electrodes 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 reaction, characterized by a uniform red pattern, can sometimes occur directly under 

the electrodes. The redness usually disappears within a few hours after treatment. Advise the patient of this possibility before 

starting treatment.

• 

Positive Polarity with Chloride Ions 

– Use only saline ampoule supplied for the return pad. For positive polarity (+), use only 

drugs with Chloride (Cl-) counter ions. Use of tap water or any other solution may cause tattooing or staining.

• 

Handle with Care 

– Handle the system with care. Do not immerse the system in fluids or allow it to be connected with other 

electrical devices. Do not drop, abuse, or in any way exceed normal use. Do not sterilize. Misuse may cause the device to 

malfunction in ways that may lead to shock or burns.

• 

Use with RF Equipment 

– Do not operate this system in an environment where other devices are being used that intentionally 

radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect 

Medical Electrical Equipment.

PRECAUTIONS

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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