Intended Use; Indication For Use; Contraindications For Use - Novoxel Tixel2 User Manual

Chapter 7: Clinical Information and Guidelines

Intended Use

Dermatological procedures requiring ablative and/or non-ablative treatment of the skin. It is indicated for
use on human skin treatments.

Indication for Use

Treatment of Actinic Keratosis.

Contraindications for Use

Note: These mentioned contra-indications should be evaluated prior to every treatment session and

not only prior to the entire treatment series.
The device is contra-indicated for use on patients who demonstrate the following conditions:

Any patient who has undergone tanning during the 4 weeks prior to any treatment session and/or any

patient who plans to undergo tanning during the 4 weeks following any treatment session [patients
who may be exposed to the sun for short periods of time occasionally are not contra-indicated as long
as they apply a high SPF sunscreen (>50)].
Herpes Simplex.

Current skin cancer, malignant sites and/or advanced pre-malignant lesions or moles in the treatment

area.
Any female who is pregnant or plans to become pregnant during the treatment period, or is currently

breastfeeding.
An impaired immune system condition or use of immunosuppressive medication.

Collagen disorders, keloid formation and/or abnormal wound healing.

Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial

treatment or plans for such treatment during the course of the Tixel2 device treatment, or before
complete healing of such treatments has occurred.
Any patient who takes or has taken any medications (including via topical application), herbal

treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin
healing during the last 3 months.
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User Manual TXLD0012
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