Artyst NR.1 Manuel D'utilisation page 29

Allergic reactions to components of
O
the aseptic pigment color
2.4.2 Risks
In some cases, minor side effects can
arise during and after the micropigmen-
tation treatment. These side effects are
listed below.
Frequent:
Local bleeding on the surface of the
O
freshly treated skin
Pain and discomfort on the first day
O
after treatment
Temporary inflammatory reactions,
O
erythema and/or edema up to 6 days
after treatment
Skin irritations (e.g. itching or heating),
O
which normally wear off during the
first 12 to 72 hours after treatment
Scabbing, which normally recedes
O
within the first 5 days
Temporary flaking of the skin, which
O
normally wears off within 8 days
artyst NO.1
Rare:
Formation of blisters of the herpes-
O
simplex virus type I (HSV-I)
Formation of small pimples or skin
O
eruptions if skin is not cleaned care-
fully before the treatment
Hyper-pigmentation with body's own
O
pigments, in particular on dark skin
types, but which disappear completely
within a few weeks
Inflammatory reactions, haematomas,
O
erythema and edema
Retinoid reaction (slight irritation up to
O
peeling of skin)
Possible warming of the pigmented
O
area under PET and MRT radiation
Basically, recently treated areas of skin
should be protected from UV radiation
and sunlight.
Furthermore, the following problems can
occur with the micropigmentation intro-
duced:
Color differences
O
Pigment loss
O
Allergic reactions to components of
O
the aseptic PMU ink
2.4.3 Required qualifications (user
requirements)
The device, including its accessories,
may not be used by persons with re-
duced physical, sensory or mental capa-
bilities, or by children. The device, includ-
ing its accessories, may not be used by
persons who lack experience and knowl-
edge, unless they are being supervised
or instructed (training).
The device may only be used by people
who have acquired the following knowl-
edge:
Qualification training for micropig-
O
mentation (permanent makeup)
Basic knowledge of micropigmentation
O
treatment (see chapter Setting the
puncture frequency
page 37)
Knowledge of the hygiene and safety
O
regulations (see chapter
page 26)
Knowledge of the risks and side ef-
O
fects (see chapter 2.4.1 on page 28
and 2.4.2 on page 29).
and 6.3 on
2.3 on
EN 29