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Asclepion MCL 31 Dermablate - Intended use

Asclepion MCL 31 Dermablate
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Introduction
2 182099015-V01-10.Juni2013-GA-MCL31-THAI
1.3 Intended use
Recommended use
Operating at a wavelength of 2.94 µm, which corresponds with maximum water absorption, the
MCL 31 Dermablate Er:YAG laser is perfectly suited for precise superficial skin ablation or cut-
ting, skin vaporization and skin coagulation.
Typical indications are: sebaceous adenoma, acne scars, epidermal nevi (soft), exophytic scars
(flat scars, no keloids), wrinkles ("skin resurfacing"), lentigines (simplex, senilis), nevi spili,
stepped scars, seborrhoeic keratosis, syringomas, xanthelasmas.
The MCL 31 Dermablate is also intended for ablative fractional skin resurfacing.
Please refer to chapter 6 Application for detailed information about the use of this device.
WARNING
Incorrect use of this device can cause serious danger to health. Therefore, all warnings,
instructions and information in this User Manual are to be observed under all
circumstances! Non-compliance is considered as misuse of the device!
No modification of this medical device is allowed!
Contra-indications
CAUTION
The intensive laser light in the infrared range can cause thermal damage to skin
structures. The contra-indications listed below are based on clinical experience in
operating laser devices for said purposes obtained over about 15 years. They do not
claim to be complete or valid indefinitely.
Microbiological infections (e.g. impetigo, herpes, pustular acne)
Heavily tanned skin
Patients with known unreasonable UV-light exposure
Tendency to hypertrophic scarring or keloids (perform a trial treatment in these cases)
Pregnancy