Instructions for Use

Indications for Use:

Zaffiro is a state-of-the-art device designed to deep clean, resurface and nourish the skin while performing noninvasive, thermo-lifting on the face and body.

Contraindications for Water Peeling

• Herpes • Diseases related to cancers • Diabetes • Serious heart conditions • Epilepsy • Diseases related to the nervous system. For example, Multiple sclerosis (MS) or Bell’s palsy. • Serious inflammatory conditions • Open wounds • Scars • Arterial diseases, such as angiomas; Lesions, local dermatitis

• Post-operative spots, up to one month after operation • Acne therapy based on isotretinoins (general or topical), up to one month after therapy • Immunological disorders. For example, HIV/AIDS. • Taking medicine that reduces the efficiency of the immune system. For example, steroids. • Hemostasis disorders • Taking anticoagulants; • Keloid scars or previous occurrences of keloid scars • Poor healing of wounds

Additional Contraindications for Thermo-Lifting Therapy

• Sunburn at the spot intended for therapy • Taking medicine that increases sensitivity to light or using topical substances inducing the similar effect within the area undergoing therapy. For example, antibiotics, diuretics, retinoids, and isotretinoin. • Any lesion should be examined by a physician prior to treatment • Facial tumors

Patient Safety:

The Zaffiro device has been designed with consideration for the highest safety standards. The Zaffiro device can cause harm to the user and/or patient if not used as instructed. The user must follow treatment procedures and abide by the guidelines defined in the Operation Manual, at all times.

Complaints and Adverse Events:

In use outside of the United States, no adverse events have been observed or reported with the use of the Zaffiro System. Neauvia North America follows FDA MDR (Medical Device Reporting) rules for handling complaints and adverse events. Should an adverse event be suspected or reported, contact Neauvia North America at (866) 836-3113; for those outside the US, contact your local Neauvia Representative.