▪ History of skin disorders, keloids, abnormal wound healing.
▪ History of bleeding coagulopathies.
▪ Any surgical procedure in the treatment area within the last 3 months or before
complete healing.
▪ Any therapies or medications which may interfere with treatment.
▪ As per the practitioner's discretion, refrain from treating any condition which might
make it unsafe for the patient.
6.4 Possible Adverse Effects
The patient must understand the importance of pre-treatment and post-treatment
instructions and failure to comply with these instructions may increase the probability of
complications.
Possible adverse effects include, but are not limited by: discomfort or pain, excessive skin
redness (erythema) and/or swelling (edema), ecchymosis, burns, damage to natural skin
texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-
pigmentation), scarring, temporary injury to nerves (neuropraxia) where nerve branches
are superficial, and very slight risk of infection.
Make sure that Handpiece is dry and intact before use.
Do not use the Handpiece if it is damaged.
6.4.1 Gamma sterilized - Instruction Prior to Use
The Gamma sterilized Handpieces are sent sterile by gamma-rays in double sterilization
bags. Therefore, the gamma sterilized handpieces SHOULD NOT be autoclaved, as the
thermal fuse of the hand piece is destroyed and the handpieces are no longer functional.
There are a few signs to recognize the gamma-sterilized handpieces:
1. There is a white sticker on the large box, stating "Gamma Sterilized" and on it is a
small red sticker. This sticker is not on the smaller individual boxes.
2. The hand pieces are packed in double sterilization bags inside a small cardboard
box, two in each box.
3. There is a silver sticker on each large and small box carrying the sign “Sterile R”
that stands for Sterilization by Radiation.
4. The color of the handpiece is green (unlike the white color of the autoclavable
handpiece).
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