Amiea Med EXCEED Instrucciones De Uso página 35

2.5 User requirements (qualifications)
The device and its accessories may only be used by persons
who have acquired the following qualifications:
Medical training
O
Basic knowledge of microneedling treatment (see
O
chapter "6.4 Setting the penetration frequency" on
page 44 and "6.3 Switching the handpiece on and off"
on page 43)
Knowledge of health and safety provisions (see
O
chapter "2.3 Important health and safety precautions" on
page 33)
Knowledge of risks and side effects (see
O
chapter "2.4.1 Contraindications" on page 34 and
"2.4.2 Side effects" on page 34)
2.6 Intended purpose, indications and
proper use
2.6.1 Intended purpose
The intended purpose of the device is the percutaneous
collagen induction (PCI) through minimally invasive injury to
the epidermis and dermis by means of fine needle punc-
tures (microneedling).
There are no open wounds caused in the skin by this,
thanks to the minimally invasive puncturing of the epidermis
and the dermis. Afterwards, the skin requires only a very
short regeneration phase in which the epithelial function will
quickly be restored.
2.6.2 Indications
Treatment of facial acne scars for clinical improvement of
the scaring, in particular through a reduction in the scar
depth and the normalisation of the skin structure.
After a total of four treatments at intervals of 30 days re-
spectively, it was possible to show a significant improve-
ment in the acne scars on the basis of the Goodman and
Baron Scar Scale within the scope of a clinical study per-
formed by MT.DERM.
2.6.3 Proper intended use
The treatment must be carried out in a dry, clean and
smoke-free environment as well as under hygienic condi-
tions. The device must be prepared, used and looked after
as described in this operating manual. In particular, the ap-
plicable requirements concerning workplace design must be
observed and the materials to be used must be sterile.
EXCEED
Intended use also includes the assumption that this operat-
ing manual and in particular chapter "2 Important safety in-
structions" on page 32, have been read in full and under-
stood.
Intended use also assumes the following consumer groups
exclusively: Adult men and women who are in good health.
Improper use is when the device or its accessories are used
in a manner other than as described in this operating
manual or if the operating conditions have not been com-
plied with. The treatment of patients with contraindications
in particular is prohibited (see chapter "2.4.1 Contraindica-
tions" on page 34).
The device is designed to be placed on a level surface. Dur-
ing use, the handpiece is to be held in the user's hand in or-
der to treat a sedentary or recumbent patient. In doing so,
the user shall operate the device at a maximum distance of
70 cm.
2.7 Symbols on the product
The symbols described below can be found in this operating
manual, on the device and on its accessories or the pack-
aging:
SYM-
MEANING
BOL
Device complies with the requirements of the
Medical Device Directive 93/42/EWG.
Attention!
Housing offers protection from coarse dust and
water drops
Housing offers protection from jets of water
Housing offers protection from foreign objects
thicker than 1 mm and against dripping water
falling at an angle
Applied part, type B: Applied part provides
safety from electrical shock and leakage cur-
rents
Handpiece
Foot switch
EN 35