Intended User; Intended Treatment Areas; Pre-Treatment Patient Preparation; Patient Pre-Treatment Preparation And Guidance - Novoxel Tixel2 User Manual

Any patient who has used oral Isotretinoin (Accutane

treatment or less.
Any patient who has a history of bleeding coagulopathies or use of anticoagulants.

Any patient who has tattoos or permanent makeup in the treated area.

Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to

be treated.
Any patient who underwent thread lifting of the area to be treated in the last 3 months.


Intended User

The operation of the Tixel2 device, including any of its components, is restricted to trained, qualified and
professionals and must be under the supervision of a physician.

Intended Treatment Areas

Any treatment area, which demonstrates any of the following, should be avoided: Hyperpigmentation,
hypopigmentation, burrowing hair, skin wounds and/or sores, infection or septic conditions, skin
inflammation, hemorrhage or risk of hemorrhage, bleeding, rash, psoriasis, eczema and/or dry and/or
fragile skin and/or any other abnormal skin condition.
Do not treat genital areas. All treatment areas must be treated with adequate settings (see below).

Pre-Treatment Patient Preparation

Patient Pre-Treatment Preparation and Guidance

Any caregiver contact with the patient should be performed using disposable gloves.

It is recommended that a physician examine the patient prior to every treatment session.

Instruct the patient not to tan for 4 weeks prior to treatment. In case the patient has to be exposed to

sun for short periods, she/he must apply a high SPF sunscreen, of at least 50.
Patients with a history of Herpes Simplex may be prescribed prophylactic drugs cord to the

physician's discretion.
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® or Roaccutane
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® ) within 3 months prior to
P/N T2-UM-E-ENG Rev 10