
Introduction
2
1590 99 002_1 - 21. February 2011
1.3 Intended use
Recommended use
The MeDioStar NeXT is a pulsed diode laser (Class 4 laser product) that is used for the removal of
unwanted hair, for the treatment of acne, for vascular treatments and for skin rejuvenation. Melanin
and blood relatively strongly absorb the range of wavelengths of the radiation emitted by this laser,
whereas the surrounding skin absorbs only a little bit of it. In this way, the radiation thermally
destroys the target structure while protecting the surrounding skin.
Please refer to chapter 6
for detailed information about the use of this device.
WARNING
The incorrect using of this device can cause serious danger to health. Therefore, all
warnings, instructions and informations of this User Manual are to be observed under all
circumstances! The non-compliance is considered as unintended use of the device!
Any modification of this medical device is not allowed !
Contraindications
CAUTION
The intensive laser light in the infrared range can cause thermal damage of skin structures.
The contraindications listed below are based on clinical experience in operating laser
devices for said purposes of during about 15 years. They do not claim to completeness or
unlimited validity.
Light sensitivity
Usage of preparations that increase sensitivity to light
Cellulite therapies in the treatment area (wait a few weeks)
Cancerous and pre-cancerous lesions in the treatment area
Haired nevi in the treatment area
Herpes simplex in the treatment area
Keloids in the treatment area
WARNING
The intensive laser light in the infrared range can cause thermal damage to the eyes.
Therefore it is NOT PERMITTED to laser the area of the eyes! Occasionally, eye
inflammation and a reduction of the visual function were observed although the eyes
were protected by eyeshields!
WARNING
The intensive laser light in the infrared range can cause thermal damage to skin structures.
Therefore it is NOT PERMITTED to use laser treatment for pregnant women or children
because clinical studies do not exist for these patients.
CAUTION
Patients with tanned skin especially fresh tanned - develop more intensive side effects,
particularly subsequent pigment changes. They should postpone the laser epilation!
Tattoos in the treatment area cause stronger side effects, too. Moreover, the color will be
partly removed. Therefore, tattoos should not be treated.
Contraindications particularly for the treatment of spider leg veins
Superficial varices with a diameter larger than 3 mm
Summary of Contents for MeDioStar
Page 1: ......
Page 2: ......
Page 3: ...User Manual MeDioStar MeDioStar NeXT...
Page 4: ...Contents 1590 99 002_1 21 Februar 2011...
Page 6: ...Contents 1590 99 002_1 21 Februar 2011...
Page 10: ......
Page 67: ...Application 1590 99 002_1 21 February 2011 57...
Page 88: ...Disposal 78 1590 99 002_1 21 February 2011 13 EC declaration of conformity...
Page 94: ......