POLLOGEN Legend Pro - Legend Pro treatment; VoluDerm Treatment using VO applicator; Pre-Treatment Preparation

Legend Pro™ System User Manual Version 7
Proprietary Information of Pollogen a company of Lumenis 46
12. Legend Pro™ treatment
This section is a safe start guidelines for treatments with the Legend Pro™ System.
This is intended as a guide only and it is not a replacement for clinical training, certification or supervised
experience. Please follow the instructions in this User Manual.
12.1 VoluDerm ™ Treatment using VO applicator
 Prior to the first treatment, a patch test should be done on a hidden area using Low, Medium and High
settings to evaluate the patient's response to the treatment. Skin reaction should be monitored
immediately and a few days after treatment. If there is an excessive and progressive skin reaction for all
settings lasting more than 2-3 days, the patient shouldn’t be treated
 Using higher parameters than needed can cause overtreatment and lead to undesired effects of the skin
 Patient safety can be ensured only when well-trained personnel operate the system
 Never treat a patient in areas that are not specified within the intended use
12.1.1 Pre-Treatment Preparation
During the first visit, the physician should assess the areas intended for treatment and take the following
actions:
• Take a detailed patient medical and physical history including previous treatment methods
• Determine if the patient is suitable for treatment - do not treat patients with any of the
contraindications outlined in this User Manual
• Determine why the patient is seeking treatment and what his/her expectations are
• Inform the patient about the course of treatment and possible side effects and discomfort
• Inform the patient about the safety warnings
• Inform the patient about post-treatment skin care. Advise the patient to avoid skin tanning or skin
irritation and that sunscreen is required when outdoors during daylight hours
• Instruct the patient to remove all jewelry prior to treatment
• Instruct the patient to shave any hair in the treatment area
• No coupling medium such as glycerin, lotion, or gel should be used during the treatment
• Topical anesthetic may be applied on the treatment area prior to treatment. It is recommended to use
EMLA. Use the anesthetic according to manufacturer guidelines. Pay attention to any contraindications
for use of the anesthesia
• Use low parameters when treating over bone areas and delicate skin
12.1.2 Treatment Guidelines:
Caution:
 In case of uncertainty regarding potential side effects, have the patients consult their physician
and bring consent for treatment.
 Verify that patient’s tolerance to the treatment was tested and verified
 Treatment area should be thoroughly cleaned: free of makeup, soap, glycerin etc.
 Make sure a suitable new and sterile treatment tip is attached correctly to the Applicator
 Before the treatment, the physician should inspect the area to be treated and determine the