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6.4 Possible Adverse Effects
Certain side effects may be experienced during treatment or shortly
afterwards which may or may not be a result of improper use of the system.
Although these side effects are rare and temporary, they should be
reported immediately to a physician for proper treatment. These are the
side effects that may appear in the treatment area:
▪ Pain
▪ Excessive redness (erythema)
▪ Swelling (edema)
▪ Muscles spasm
▪ Treatment area infection
▪ Skin irritation and burns beneath the electrodes have been reported
with the use of powered muscle stimulators.
▪ Skin burns
▪ Pigmentation change
▪ Scar
6.5 Applicator Cleaning Instructions Prior to Use
These cleaning instructions are for clinical use only.
The following processes validated for the Transform Applicators when used
in accordance with the instructions provided for cleaning products and/or
processes.
Any deviation from said instructions or the cleaning agents listed below
may affect the performance or durability of the product, and it’s prohibited.
Review those instructions for additional warnings and cautions.
We recommend the usage of the following cleaning agent that was tested
in our company for material compatibility as 70% alcohol solution.
Cleaning Procedure
▪ Thoroughly clean the applicator with 70% alcohol absorbed pad for at
least 30 sec and repeat as necessary.
▪ Leave it for complete drying.
Pre-use Check
Before each use of the Applicator, the device must pass the following:
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