11
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NC iQ
2.6 Required Qualifications (User Requirements)
The device including its accessories is not to be used by persons (including children) with
reduced physical, sensory or mental capabilities. The device including its accessories is not
to be used by persons with lack of experience and knowledge, unless they have been given
supervision or instruction (training).
The device may only be used by persons that have completed the following training:
O
Qualification for micro-pigmentation/PMU
O
Basic knowledge of micro-pigmentation treatments (see chapter 6.4 and 6.5) on page 26
O
Knowledge of the hygiene and safety regulations (see 2.3 "Important hygiene and safety
regulations“ on page 8ff)
O
Knowledge of the risks and side effects (see chapter 2.4 "Contraindications“ on page
9 and 2.5 "Side effects“ on page 10)
2.7 Purpose, scope and intended use
2.7.1 Purpose
The purpose of the device is to facilitate the minimally invasive micro-pigmentation of sterile
or aseptic pigments of mineral or organic origin into the dermis (permanent make-up).
No open wounds are left in the skin due to minimally invasive puncturing of the epidermis
or dermis. This allows the epithelial function to be restored very quickly and the treatment
requires only a very short recovery period.
2.7.2 Area of application
Application examples for micro-pigmentation (PMU) are:
O
Pigmenting eyebrows
O
Pigmenting eye-liners
O
Pigmenting lip-liners and/or filling in lip colour
O
Cosmetic pigmentation of the areola
O
Cosmetic pigmentation of the body
2.7.3 Intended use
The procedure must be done in a dry, clean and smoke-free environment, and always under
hygienic conditions. The device must be prepared, used and maintained as described in this
operating manual. In particular, the applicable provision of workplace design must be taken
into account and the materials used must be sterile.
Proper use also includes these operating instructions and especially the chapter “Important
Safety Notes" being fully read and understood.
Intended use includes only the following groups of consumers: Adult men and women at
least 18 years of age who are in a good state of health.
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