Alma Opus - Page 41

Clinical Guide – all fields
Page A-3
B.3.4 Contraindications (Opus Colibri Applicator and Tips)
• Active infectious disease
(fungal/bacterial/viral/parasitic)
• Impaired immune system
• History of cancer in the treatment area less than 5
years
• Metal implants near treatment area
• Burns in the treatment area
• Extensive radiation therapy
• Pregnancy or IVF procedure and lactating
• Active collagen or vascular disease
• Coagulation disorder (coagulopathy)
• Scleroderma
• Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
• History of Keloid formation or wound healing process abnormalities in the treatment area
• Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months
B.3.5 Adverse Events and Side Effects (Opus Colibri Applicator and Tips)
The use of the system may cause:
• Heating sensation or pain – Patient may experience a heating sensation during or just following
the treatment, however, such pain is expected to be mild and resolved within a few minutes.
• Erythema –Redness in the treated area is expected and should disappear within 24 hours.
• Burns –Skin burns should be treated conventionally.
• Dry skin –Dryness can be detected up to12 hours post-treatment. Usually resolves spontaneously
within 48 hours. Lubrication with moisturizing cream is recommended.
• Transient skin scabbing -lasting up to 2 weeks
• Post inflammatory hyperpigmentation (PIH)
B.3.6 Accessories and Equipment
• Topical anesthetic (“EMLA”)
• 70% Alcohol (for cleaning skin and tip)