Alma Opus - Contraindications and Adverse Events

Clinical Guide – all fields
Page A-2
B.3.1 Contraindications (Opus Plasma 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.3.2 Adverse Events and Side Effects (Opus Plasma 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 to resolve within few
minutes.
• Erythema – may be present in the treated area and will likely disappear after 24 hours.
• Burns – might occur if the operator does not follow instructions, i.e. energy too high or
staying too long with the applicator on the same spot. If such a burn occurs, it should be
treated conventionally.
• Dry skin – may occur at the first 12 hours post-treatment. Usually it will resolve
spontaneously within 48 hours. Lubrication with moisturizing cream can be helpful.
• Transient skin scabbing -lasting up to 2 weeks
• Post inflammatory hyperpigmentation (PIH)
B.3.3 Accessories and Equipment
• Surgical marker
• Surgical pen (blue or violet)
• Medical/office bed (pneumatic is recommended)