Instructions for use
Important: To be read before use
1. Presentation, identification, and traceability.
Semi-permanent colors implants intended for the pigmentation of the skin are made up of pigments in dispersion in glycerol, propylene, and additives in conformity with the Israeli pharmacopeia. The implant is conditioned in sterile packing. The implant is identified by it’s name, it’s reference and it’s bath number with must be kept by the beauty professional and must be noted on the implant customer card with the Date of the procedure. The composition and the sterile presentation are in conformity with the 93/42/EEC Directive, class 2 b, concerning the medical device.
No product of Human or Bovine origin contains.
2. Indication. Â The colored implant is intended to be put sterile in the dermis with a repairing or is an aesthetic aim.
The colored implant should not be used in the event of infection or skin disease (recent or old), hypergenic scars, a disease of the organ close to the skin (eye), or in a case of general diseases. Micro-pigmentation should not be practiced on a child or pregnant woman. The pigmentation is prohibited among allergic Patients, whatever is the form (allergy of the skin, to the food, to drugs, asthma or else). The pigmentation is prohibited for carriers of prosthesis (cardiac in particular), for Clients presenting a disorder of coagulation or taking drugs having a thinning blood effect (Aspirin, anti-inflammatory drugs or else)
4. Precaution for use.
Only a qualified trained professional person can practice the Micro-pigmentation procedure. A systematic test should be carried out before pigmentation. A positive reaction to the test contraindicated the implantation. In the event of an ambiguous answer, one’s has to do the second test. It is misadvised practicing a pigmentation after a filling of wrinkles or lips (prohibited after a filling with a permanent material such a silicone or PTFE). One’s must respect a period of several months between the pigmentation and an aesthetic treatment of the skin (laser, piling, abrasion and etc.). The site of implantation must be carefully disinfected. It is recommended to the patients not to wear makeup and not wet the pigmented zone, not to expose itself to the sun during the week following the treatment. Care after the act must be to done to avoid an infection and protect the colored area from the aggressions of the environment.
5. Potential side effect and complication.
As for many tattooing acts, complications and infections can occur without they were due to the implant. The professionals have to inform the clients for possible side effects, in an immediate or delayed way: inflammatory reaction, pain… These reactions can persist one or two weeks. An onset or Herpes can require a specific treatment. At the time of MRI exploration, the patients can present pain, irritation or edema at the zone of pigmentation. Ones can also observe a reactivation of dermatological disease: a week coloring because of poor implantation. The occurrence of a significant change of color must be checked by the test. Any other undesirable side effect related to the implantation of the device must be declared to IMPAR – “Magic Cosmetics”.
This product is for professional use only by qualified and trained professional person. Don’t re-sterilize, check the integrity of the packing before use. Don’t use the implant in case of unusual looking (anomaly of color or aspect). In this case, you have to inform the company IMPAR – “Magic Cosmetics”. The device must be stored in the packing in origin in a cool dry place. The implants must be preserved under normal and physiological environmental condition (pressure, temperature, irradiation, electric and magnetic field, acceleration or else). If this precaution is not respected, the implant must not be used.