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PATCH SPECIFICATIONS

Classifications:

Internally Powered. Type BF Applied Part

Battery:

Contains two 3-Volt non-rechargeable lithium 

manganese dioxide button cell batteries

Environmental Conditions:

Storage

: 15°C  -  30°C

 

(59°F- 86°F)

 

DO NOT expose to 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” x 0.4”)

Weight: 

6 g (0.2 oz.)

Disposal:

Dispose according to local, state and federal regulations.

Dose range: 

0-80 mA-minutes

Maximum Voltage:

6.8 V (Patch only)

Maximum Current:

3.4 mA (Patch only)

Number of uses:

The Patch is designed for only one use.

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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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