Possible Adverse Effects; Pre-Treatment - InMode Envision Operator's Manual

Envision System Operator Manual
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Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
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Vitiligo.
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Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning
creams and sprays within the last two weeks.
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As per the practitioner's discretion, refrain from treating any condition which might
make it unsafe for the patient.
Do not treat the upper eyelids and the lips!
Do not treat over tattoo and permanent makeup!
Permanent hair reduction may occur in the treated area.
Do not treat over an area with a high density of hair. Absorption of light by hair
follicles may cause an adverse skin reaction.
6.3.

Possible Adverse Effects

Possible adverse effects include but are not limited by: discomfort or pain, excessive skin
redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister,
and burn), change of pigmentation (hyper- and hypo-pigmentation), and scarring.
Erythema, lasting not longer than 24h is a typical skin reaction to the Lumecca treatment.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the probability
of complications.
6.4.

Pre-Treatment

During the patient's first visit the treating attendant should:
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Complete or update the patient's medical and physical history.
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Exclude from treatment anyone with the listed contraindications.
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Determine why the patient is seeking treatment and what his/her expectations are.
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Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
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Instruct the patient about the safety warnings.
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Advise the patient to avoid skin irritation or skin tanning for at least 2 weeks.
Sunscreen is advisable during outdoor activity at daylight hours.
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Patient should discontinue any irritant topical agents for 2-3 days prior the treatment.
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Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
Section 6: Lumecca Treatment Information
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