Amiea Med EXCEED Instrucciones De Uso página 34

Please be sure to inform your patient to avoid contact with
recently treated skin. Recently treated areas of skin should
also be protected from
Contamination and
O
UV and solar radiation
O
. Additional irritants such as
visits to swimming pools or saunas,
O
abrasive or chemical peelings,
O
hair removal at the treated areas or
O
self-tanning products
O
should be avoided by the patient in the first two to three
days after the treatment.
2.4 Contraindications and side effects
The following contraindications and side effects are the res-
ults of a thorough analysis of the professional clinical literat-
ure concerning microneedle treatment. If the person re-
sponsible for the treatment should have the smallest doubt
that the safety of the patient cannot be guaranteed, for ex-
ample due to secondary illnesses or conditions, the treat-
ment should be withheld or stopped immediately.
2.4.1 Contraindications
With the following contraindications, no microneedling
treatment should be performed:
Haemophilia or other blood-clotting disorders
O
Ongoing use of blood thinning medication (e.g. acet-
O
ylsalicylic acid, warfarin, aspirin, heparin)
Unregulated diabetes mellitus
O
Any form of active acne in the area of the treatment
O
Dermatosis (e.g. skin tumours, keloids or extreme sus-
O
ceptibility to keloid formation, solar keratosis, warts and/
or moles) in the area of the treatment
Open wounds and/or eczema and/or rashes in the area
O
of the treatment
Scars younger than 6 months
O
Systemic infections and infectious diseases (e.g. hepat-
O
itis of types A, B, C, D, E or F; HIV infection) or acute
local skin infections (e.g. herpes, rosacea)
During chemotherapy, radiotherapy or high-dosage cor-
O
ticosteroid therapy (recommendation: from 4 weeks be-
fore the start until 4 weeks after the end of the therapy)
Up to 12 months after a plastic surgery operation in the
O
area to be treated
Up to 6 months after filler injections in the area to be
O
treated
Allergy to topical anaesthetics (local anaesthetic)
O
34 EN
Under the influence of alcohol and/or drugs
O
Pregnancy and lactation
O
The treatment of mucous membrane and eyeballs is strictly
forbidden.
The treatment must be immediately aborted in the event of:
Excessive perception of pain
O
Fainting/dizziness
O
2.4.2 Side effects
In order to avoid unnecessary side effects:
Find out the patient's medical history and possible previ-
O
ous surgical procedures before the treatment.
Ensure that patients with a herpes simplex virus infec-
O
tion have been treated beforehand with a prophylactic
antiviral therapy.
Complications during and after a microneedling treatment
seldom occur in comparison to alternative methods of scar
treatment and are generally minor. In most cases, this is loc-
alised bleeding in the area of the treated skin. In some
cases, minor side effects may also arise. The following side
effects are reported in the professional clinical literature.
Frequent:
Pain and discomfort on the first day after the treatment
O
Short-term inflammatory reactions, erythema and/or
O
oedema up to 6 days after the treatment
Skin irritations (e.g. itching or increased temperature),
O
which normally subside during the first 12 to 72 hours
after the treatment
Formation of scabs, which normally recede in the first 5
O
days
Temporary peeling of the skin which normally subsides
O
within 8 days
Seldom:
Formation of herpes simplex virus type I (HSV-I) blisters
O
Formation of small pustules or milia as a result of inad-
O
equate cleaning of the skin prior to treatment
Hyperpigmentation with the body's own pigments, in par-
O
ticular with darker skin types, but completely cleared up
within a few weeks
Inflammatory reactions, haematoma, erythema and oed-
O
ema
Retinoid reaction (from slight reddening to peeling of the
O
skin)
As a matter of principle, recently treated skin areas should
be protected from UV and solar radiation.
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