Instructions For Use

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Indications

The DESCRIBE^® PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.

 

Contraindications

The DESCRIBE^® PFD Patch is contraindicated for patients with dermatological conditions that would disrupt the integrity of the skin in the area of application. Do not use on open wounds.

 

Instructions For Use

1. Procure swabs.
2. Ensure treatment area is clean and dry.
3. Verify that liquid perfluorodecalin (PFD) is present within the pouch.
4. Tear open top of pouch along dotted line.
5. Immerse swab in liquid PFD within pouch.
6. Pre-wet treatment area with PFD-coated swab.
7. Remove Patch from pouch.
8. Peel Patch from its release liner.
9. Because PFD evaporates quickly, promptly apply Patch with the adhesive surface making contact with the treatment area.
10. Treat directly through the transparent Patch with selected laser.
11. Do not use more than two Patches per patient per treatment session.
12. Immediate laser retreatments may be performed in accordance with clinical signs and symptoms.
13. Discard the single-use Patch after use. Follow local governing ordinances regarding proper disposal of medical waste.

 

Precautions

1. For use only with laser and settings selected by trained laser operator.
2. Single-Patient-Use Only. Risk of cross-contamination. Do not reuse.
3. Do not use if product is opened, damaged, opaque or visually defective.
4. If the Patch becomes darkened or opaque with ejected pigment, replace it with a fresh DESCRIBE PFD Patch.
5. Although the product is non-flammable, keep away from open flame.
6. Wear protective gloves and safety glasses. (i.e., undamaged, form fitting to the face, and those that offer protection for the wavelength being used for treatment)
7. Do not perform more than four laser passes per treatment session.

 

Potential Adverse Events

The use of the DESCRIBE PFD Patch does not alter Potential Adverse Events from those encountered with the use of lasers alone. These potential adverse events may include pain, burns, abrasions/cuts/wound, eye/vision damage (improper use or lack of protective eyewear), necrosis, redness, swelling, pigmentary changes, infection, scabbing, scarring, crusting, bruising, itching, flaking, or blistering. Allergic reaction could occur in individuals sensitive to components of the patch.

 

Usage Note

The DESCRIBE^® PFD Patch does not attenuate or scatter dermatological laser treatment light. The user is not required to modify laser settings and may use maximum tolerable fluence in accordance with clinical signs and symptoms.