Instruction For Use

Intended use

System ONE-M is intended for non-invasive tattoo removal and other aesthetic HIFU treatment of the human skin. It is used by qualified and trained healthcare professionals with knowledge to ultrasound, laser, electrotherapy, photodynamic therapy or similar clinical practices.

HIFU tattoo removal comprise treatments in which the skin is treated by closely spaced HIFU shots to fully or partly cover a tattoo. The skin reacts by forming a coherent wound crust, which contains a large part of the tattoo pigments in the treated tattoo. During healing of the superficial ultrasound skin lesion, the wound crust will gradually be expelled and replaced with new skin tissue without tattoo pigmentation.

Other aesthetic HIFU treatments include a wide range of non-medical dermatological conditions of aesthetic nature originating in the upper layers of the human dermis and epidermis. Such conditions for example include:

• Solar Lentigines (liver spots)
• Angiomas (cherry spots and venous lakes)
• Telangiectasia (spider veins)
• Fine-line wrinkles

Treatment dynamics for these conditions are analogous to that described for tattoo removal above. Depending on the treated condition, the density of treatment shots within a lesion, and the chosen dept of the ultrasound focal point relative to the layer of the skin, the treatment can be set to produce a continuous superficial skin necrosis or a superficial crustation only.

In superficial conditions exemplified by solar lentigines, a treatment with more scattered lesion coverage, and thereby a less severe horizonal synergy between each ultrasound shot may be more appropriate to quickly generate a desired aesthetic result with fast healing. A treatment for the above conditions therefore typically involves less treatment points with less and more superficial coverage compared to the case of HIFU tattoo removal. Tattoo pigment is situated in the outer 1/3 of the skin contrasting the more superficial aesthetic conditions.

 

Indication for use

The patient population is adults.

The user environment is hospital and dermatology clinics etc.

System ONE-M is for multiple use, supplied non-sterile, but to be cleaned between use.

The handpiece is for multiple use, supplied non-sterile, but to be cleaned before and after each session.

The shelf life is 12 months when stored in empty and dry state.

Duration of use is limited (≤ 24 hours). An average active  treatment session takes approximately 30 minutes.

System ONE-M is limited to a maximum energy emission of 1.3 J/shot. Under average use conditions a session consist of approximately 500 shots at 1 J/shot. Within the treatment session, the active HIFU transmission from the handpiece is typically in the range of 100 – 200 ms/shot, and the total active transmission is therefore less than 2 minutes per session.

The handpieces are limited to a maximum energy emission of 30 kJ. Under average use conditions as above, this corresponds to approximately 60 non-invasive sessions per handpiece with a duration of approximately 30 minutes of active HIFU treatment per session. This gives approximately 30 hours of treatment time per handpiece with active HIFU transmission of approximately 50 – 100 minutes.

 

Contraindications

The System ONE-M is contraindicated for:

• Ophthalmic use or any use causing the acoustic beam to enter the eye.
• Use on subjects less than 18 years at the time of the start of the treatment.
• Female patients who are pregnant, may be pregnant, or lactating.
• Treatment areas containing a breached dermis, e.g. an open wound or similar.
• Treatment areas located above or adjacent to (<5 cm) an implant (active or inactive).
• Treatment of subjects with known blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
• Treatments of subjects with a known history of pathological scar formation (e.g. keloid scarring).

 

Precautions

System ONE-M has not been evaluated, and is not recommended for use on subjects with the following subjects / conditions:

• Subjects with a systemic or local skin disease that may influence wound healing.
• Subjects with known immune-mediated dermatological disease.
• Subjects with diabetes.
• Subjects with epilepsy.
• Treatment on or nearby an existing keloid.
• Treatment on subjects genitalia.

 

Potential Side effects

Side effects reported during evaluation of the device are generally mild and transient in nature. The following effects have been observed:

Wheal-and-flare reaction: A wheal-and-flare reaction, characterized by an urticaria-like reaction with flared redness surrounding the treatment area, is a normal and immediate reaction to HIFU treatment. The reaction typically peaks after 5 – 10 min and fades over the subsequent 10 – 30 min.

Inflammation: Redness and swelling/edema in the treated area is common during the post treatment period. Inflammation may exceptionally persist for a few weeks depending on the location and intensity of the treatment and the healing dynamics of the subject. Inflammation normally decrease gradually over a few weeks, but subclinical inflammation may persist for over 3 months in rare cases.

Edema (swelling): The treated area may exhibit mild inflammatory edema, both of the treated area and the immediately 1-3 cm adjacent area following treatment. This typically resolves within 3 to 72 hours of treatment.

Erythema (redness): The treated area may exhibit inflammatory redness/erythema 1-2 days after a treatment. This condition typically resolves within a few days treatment.

Pain: Pain directly on HIFU application is short and confined to the site and limited in time to the ultrasound shot only.

A typical mild degree of tenderness to touch is related to post treatment inflammation, and resolves within a few days after the treatment.

Bruising: Mild bruising, which is caused by damage to dermal blood vessels, may occur in rare cases and typically resolves within 2 weeks of treatment.

Itching: Mild itching may result during the inflammatory healing phase, starting after treatment, typically resolving over a few days along with the spontaneous resolution of inflammation of the treated site.

Infection: Infections may result from bacterial intrusion during the time where the skin barrier is open. Infections will normally start within the first 1-2 weeks after the HIFU treatment. In case subjects suspect infection they should seek medical advice/assistance as soon as possible whether to start antibacterial treatment.

Dyspigmentation: The treatment may potentially destroy the melanocytes producing the brown skin pigment. Hypopigmentation for periods above 12 month may therefore appear. Subjects with dark skin types, i.e. Fitzpatrick Type 3 and above, are at higher risk of experiencing permanent dyspigmentation. Hyperpigmentation may be present for a few months depending on the degree of post treatment inflammation and the constitutive skin color and ethnicity of the person.

Scarring: Scar formation in the treated field (which may respond to medical care) may occur if incorrect treatment technique is used. Scars are more likely to form if the treated area is subjected with secondary infection or insufficient wound care. Patients with tendencies for easy scar formation have high risks for scar formation after treatment. Scarring depends on anatomical site; risk is higher on the chest and on the shoulder.

 

 

Please contact us for a complete IFU document for more details about the system and its cautions and warnings etc.