Purpose, Application Area And Intended Use; Purpose - Indications For Use; Application Area; Intended Use - Requirements For Safe Use - MT.DERM artyst NR.1 Instrucciones De Uso

2.5 Purpose, application area and
intended use
2.5.1

Purpose - Indications for use

The purpose of the device is the mini-
mally invasive penetration of sterile or
aseptic PMU inks of mineral or organic
origin into the dermis by means of mi-
cropigmentation (permanent make-up).
Due to the minimally invasive puncturing
of the epidermis (top layer of skin) and
dermis (middle layer of skin), the skin
does not bear any open wounds. There-
fore, the skin needs only a very short re-
generation phase, in which the epithelial
function is quickly restored.
2.5.2

Application area

Application examples for micropigmen-
tation (permanent makeup) are:
Pigmenting eyebrows
O
Pigmenting eye-liners
O
Pigmenting lip-liners or filling in the
O
lip color
Cosmetic pigmentation of the body
O
30 EN
2.5.3 Intended use - requirements
for safe use
The treatment must take place in a dry,
clean and smoke-free environment, and
under hygienic conditions. The device
must be prepared, used and maintained
in the manner described in this operating
manual. In particular, the applicable pro-
visions for workplace layout must be ob-
served, and the materials to be used
must be sterile.
Intended use also includes thoroughly
reading and understanding this operat-
ing manual, in particular the chapter Im-
portant safety notices.
The intended use exclusively includes the
following consumer groups: Adult men
and women who are in good health.
Unintended use is defined as using the
device or its accessories in a way other
than as described in this operating man-
ual, or failing to comply with its operat-
ing conditions. In particular, treatment of
contraindications is prohibited (see chap-
ter 2.4.1 on page 28).
2.6

Symbols on the product

The symbols described below can be
found in this operating manual, on the
device, its accessories or packaging:
Symbol Meaning
Satisfies the requirements of
directives 2014/35/EC (Low-
Voltage Directive) and
2014/30/EU (EMC Directive)
Attention!
Standby/Operation
Handpiece
Foot switch
DC connection / positive inner
pin
Housing provides protection
IP20
against coarse dust
Refer to operating manual!
Protection with double or rein-
forced insulation according to
Protection Class II
Manufacturer
artyst NO.1