Pre-Treatment Recommendations
1.) During the patient’s first visit, the treating attendant should:
- Complete or update the patient’s medical and physical history.
- Exclude from treatment anyone with the listed contraindications.
- Determine why the patient is seeking treatment and what his/her expectations are.
- Inform the patient about treatment arrangement, typical treatment results and possible adverse effects and discomfort.
- Instruct the patient about the safety warnings.
- Advise the patient to avoid skin irritation and discontinue any irritant topical agents 2 – 3 days prior to treatment.
- Determine accurately the patient’s Fitzpatrick skin type.
- Avoid intentional skin tanning. Sunscreen is advisable when patient is outdoors during daylight hours.
- Asian patients and patients with skin types IV to light V may also be treated with bleaching products 3 to 4 weeks prior to treatment. E.g., 4, 6 or 8% hydroquinone cream which may contain 0.1% retinoic acid, 4% kojic acid and 1% desonide base or plant extracts such as Lumixyl. Proposed protocol is 2 times for the first 1 – 2 weeks, 3 times for the next 1 – 2 weeks, every other day for the last 1 – 2 weeks and stop 48 to 72 hours prior to the iFRAX Fractional RF treatment.
2.) Thoroughly clean the treatment areas(s).
Note: Patient should shave the area(s) being treated. Long and dense hairs prevent electrode contact with the skin’s surface.
3.) The D-pin (sharp) needle cartridges are shipped in sterile packages. Be sure that the sterile packaging has not been damaged, torn or contaminated before using. THE D-PIN CARTRIDGES ARE SINGLE USE ONLY AND MUST BE DISPOSED OF AFTER EACH USE. DO NOT RE-USE—EVEN ON THE SAME PATIENT.
4.) Before each use of the iFRAX fractional handpiece and sharp needle cartridge, check the handpiece components’ integrity and the sterile packaging of each cartridge.
5.) Test spots: A small test spot should be performed in a non-conspicuous area of the treatment site (or adjacent region, e.g. behind the ear) prior to the first complete treatment session. The test spot is performed to establish the following requirements:
6.) To confirm the patient’s response for treatment. For skin type I – III, wait 10 – 15 minutes before assessing the skin response. For skin types IV – V, wait longer due to delayed response of dark skin. Asian patients consider using the test spot and waiting a period of time of 2 – 3 days when moderate and higher energy levels are used to determine the skin response.
7.) To assess lesions and determine treatment parameters. The deeper the lesions (wrinkles and depressed scars) the stronger the ablation needed and the higher the energy level to be used. If the desired end-point of erythema and edema in a tip shaped pattern has not been achieved within 10 – 15 minutes, increase the RF energy % in increments of 5%. If the response is excessive, decrease this parameter.
8.) To test the tolerance of patient to the treatment. If treatment is not tolerable to the patient and causes discomfort, topical or local anesthesia may be used.
Contraindications in the use of the iFRAX Fractional RF System include:
- Patients who have been taking more than one tablet of aspirin per day in the preceeding month. Pacemaker or internal defibrillator or other implanted electronic device.
- Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane.
- Take allergy and drug reaction history before-hand. If allergic reaction occurs, keep drugs like adrenaline, intubnbation set, iv-fluids and oxygen cylinder ready always.
- Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox®/HA/collagen/fat injections or other augmentation methods with bio-material, until the product has been dissipated (up to 6 months), except Botox after binding to the facial muscles (3 – 7 days). It is possible to treat sooner over injectable products placed in the deep, periosteal plane, as soon as the area has healed (1 – 3 weeks).
- Current or history of skin cancer or any other type of cancer or pre-malignant moles.
- Severe concurrent conditions such as cardiac disorders.
- Pregnancy and nursing.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area may be treated only following a prophylactic regime.
- Poorly controlled endocrine disorders such as diabetes.
- Any active skin condition in the treatment area such as sores, psoriasis, eczema and rash.
- History of skin disorders, keloids, abnormal wound healing as well as very dry and fragile skin.
- History of bleeding coagulopathies.
- Use of anticoagulants in the last 10 days.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session is a relative contraindication as per the practitioner’s discretion.
- Use of lsotretinoin (Accutane) within 6 months prior to treatment.
- Any facial surgery performed within a year prior to treatment.
- Facial dermabrasion, facial resurfacing or deep chemical peeling within the last 3 months.
- Superficial or medium depth chemical peeling in the last 1 – 6 weeks according to treatment depth and severity.
- Having received treatment with light, laser, RF or other devices in the treated area within 2 – 3 weeks for non-ablative procedures and 6 – 12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations.
- Treating over tattoo or permanent make-up.
- Treating over eyebrows or other hair-bearing surfaces.
- Skin type VI and dark V patients.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last 2 weeks.
- As per the practitioner’s discretion, refrain from treating any condition that might make it unsafe for the patient.